UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

Form 10-K

(Mark One)


☑	ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the fiscal year ended ~~December~~January 272, ~~2024~~2026


☐	TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from to

Commission file number: 0-11634

STAAR SURGICAL COMPANY

(Exact name of registrant as specified in its charter)


Delaware		95-3797439
(State or other jurisdiction of incorporation or organization)		(I.R.S. Employer Identification No.)
25510 Commercentre Drive Lake Forest, California		92630
(Address of Principal Executive Offices)		(Zip Code)

(626) 303-7902

(Registrant’s telephone number, including area code)

Securities registered pursuant to Section 12(b) of the Act:


Title of each class	Trading Symbol(s)	Name of each exchange on which registered
Common	STAA	NASDAQ

Securities registered pursuant to Section 12(g) of the Act: None

Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes ☑ No ☐

Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act. Yes ☐ No ☑

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☑ No ☐

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☑ No ☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.


Large accelerated filer	☑	Accelerated filer	☐
Non-accelerated filer	☐	Smaller reporting company	☐
Emerging growth company	☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Indicate by check mark whether the registrant has filed a report on and attestation to its management’s assessment of the effectiveness of its internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered public accounting firm that prepared or issued its audit report. ☑

If securities are registered pursuant to Section 12(b) of the Act, indicate by check mark whether the financial statements of the registrant included in the filing reflect the correction of an error to previously issued financial statements. ☐

Indicate by check mark whether any of those error corrections are restatements that required a recovery analysis of incentive-based compensation received by any of the registrant’s executive officers during the relevant recovery period pursuant to §240.10D-1(b). ☐

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☑

The aggregate market value of the voting and non-voting common equity held by non-affiliates of the registrant as of June 2827, ~~2024~~2025, the last business day of the registrant’s most recently completed second fiscal quarter, was approximately $2883,~~340~~907,~~566,448~~564 based on the closing price per share of $4716.6192 of the registrant’s Common Stock on that date.

The registrant has 49,~~325~~888,~~372~~379 and 49,512,749 shares of common stock, par value $0.01 per share, issued and outstanding, respectively, as of February 1827, ~~2025~~2026.

DOCUMENTS INCORPORATED BY REFERENCE

Portions of the registrant’s definitive proxy statement relating to its ~~2025~~2026 annual meeting of stockholders, which will be filed with the Securities and Exchange Commission pursuant to Regulation 14A within 120 days of the close of the registrant’s last fiscal year, are incorporated by reference into Part III of this report.

STAAR SURGICAL COMPANY

TABLE OF CONTENTS

		PAGENUMBER
PART I		2
ITEM 1.	Business	2
ITEM 1A.	Risk Factors	1718
ITEM 1B.	Unresolved Staff Comments	3032
ITEM 1C.	Cybersecurity	3132
ITEM 2.	Properties	3234
ITEM 3.	Legal Proceedings	3234
ITEM 4.	Mine Safety Disclosures	3234
PART II		3234
ITEM 5.	Market for Registrant’s Common Equity, Related Stockholder Matters, and Issuer Purchases of Equity Securities	3234
ITEM 6.	[Reserved]	3336
ITEM 7.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	3437
ITEM 7A.	Quantitative and Qualitative Disclosures About Market Risk	4247
ITEM 8.	Financial Statements and Supplementary Data	4347
ITEM 9.	Changes in and Disagreements with Accountants on Accounting and Financial Disclosure	4347
ITEM 9A.	Controls and Procedures	4347
ITEM 9B.	Other Information	4650
ITEM 9C.	Disclosure Regarding Foreign Jurisdictions ~~That~~that Prevent Inspections	4650
PART III		4650
ITEM 10.	Directors, Executive Officers, and Corporate Governance	4650
ITEM 11.	Executive Compensation	4650
ITEM 12.	Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters	4651
ITEM 13.	Certain Relationships and Related Transactions, and Director Independence	4751
ITEM 14.	Principal Accounting Fees and Services	4751
PART IV		4751
ITEM 15.	Exhibits and Financial Statement Schedules	4751
ITEM 16.	Form 10-K Summary	5054
SIGNATURES		5155

PART I

SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS AND INDUSTRY DATA

This Annual Report on Form 10-K (Annual Report) contains statements that constitute “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended (Securities Act), and Section 21E of the Securities Exchange Act of 1934, as amended (Exchange Act), and the Private Securities Litigation Reform Act of 1995, and is subject to the safe harbor created therein. All statements other than statements of historical or current facts in this report or referred to or incorporated by reference into this report are forward-looking statements. These statements include comments regarding the intent, belief or current expectations of the Company and its management. In some cases, readers can recognize forward-looking statements by the use of words like “anticipate,” “estimate,” “expect,” “project,” “intend,” “may,” “plan,” “believe,” “will,” “should,” “could,” “forecast,” “potential,” “continue,” “ongoing” (or the negative of ~~these~~those words and similar words or expressions), although not all forward-looking statements contain these words. Forward-looking statements contained in this Annual Report include, without limitation, statements regarding the intent, belief or current expectations of the Company and its management regarding any of the following: demand for our Implantable Collamer® Lenses (ICLs); the benefits of our leadership realignment and related efforts; China macroeconomic conditions, procedure volumes, demand, and inventory levels; any projections of or guidance as to future earnings, revenue, sales, profit margins, expense rate, cash, effective tax rate, product mix, capital expense or any other financial items; ~~our expectations regarding~~ the ~~demand for ICLs in China and the macroeconomic trends in China; the~~ plans, strategies, and objectives of management for future operations or prospects for achieving such plans, including statements under the caption “Strategic Imperatives for ~~2025~~2026” in Part II. Item 7. “Management’s Discussion and Analysis of Financial Condition and Results of Operations”; statements regarding new, existing, or improved products, including but not limited to, expectations for success of new, existing, and improved products in the U.S. or international markets or government approval of a new or improved products; commercialization of new or improved products; future economic conditions or size of market opportunities globally; expected costs of operations; statements of belief, including as to achieving business plans for ~~2025~~2026 and beyond; expected regulatory activities and approvals, product launches, and any statements of assumptions underlying any of the foregoing. We caution investors and prospective investors that any such forward-looking statements are not guarantees of future performance and involve risks, uncertainties, assumptions and other factors, which if they do not materialize or prove correct, could cause actual results to differ materially from those expressed or implied by such forward-looking statements. We caution you not to place undue reliance on these forward-looking statements and to note they speak only as of the date hereof. Factors that could cause actual results to differ materially from those set forth in the forward-looking statements are included in the risk factors set forth in Item 1A, “Risk Factors.” We disclaim any intention or obligation to update or revise any financial projections or forward-looking statements due to new information or other events, except as required by law.

This Annual Report contains estimates, projections and other information concerning the ophthalmic industry, our business, and the markets for certain medical conditions, procedures, and products. Information that is based on estimates, forecasts, projections, market research or similar methodologies is inherently subject to uncertainties and actual events or circumstances may differ materially from the estimates and forecasts reflected in this information. Unless otherwise expressly stated, we obtained this industry, business, market, and other data from reports, research surveys, studies, and similar data prepared by market research firms and other third parties, industry, medical and general publications, government data, and similar sources.

In order to assist investors and prospective investors with an understanding of the ophthalmic industry, our business, certain medical conditions, procedures and products, we have included in this Annual Report a discussion of the structure and function of the human eye, commencing on page 8, and a glossary explaining many of the technical terms used in this Annual Report, commencing on page 1516.

ITEM 1. Business

STAAR Surgical Company designs, develops, manufactures, and sells implantable lenses for the eye and accessory delivery systems used to deliver the lenses into the eye. We are the leading manufacturer of phakic implantable lenses used worldwide in corrective or “refractive” surgery. We have been dedicated solely to ophthalmic surgery for over 40 years. Our goal is to position our refractive lenses throughout the world as primary and premium solutions for patients seeking visual freedom from wearing eyeglasses or contact lenses while achieving excellent visual acuity through refractive vision correction. Unless the context indicates otherwise, “we,” “us,” the “Company,” and “STAAR” refer to STAAR Surgical Company and its consolidated subsidiaries.

STAAR generates worldwide revenue almost exclusively from sales of our ~~implantable~~Implantable Collamer ~~lenses~~Lenses, or “ICLs.” Our ICLs are made from Collamer, which is a proprietary collagen copolymer material created and exclusively used by STAAR to make our lenses soft, flexible and biocompatible with the eye. Our ICLs are phakic lenses, meaning that they are implanted into the eye without removing the eye’s natural crystalline lens. This

exclusively used by STAAR to make our lenses soft, flexible and biocompatible with the eye. Our ICLs are phakic lenses, meaning that they are implanted into the eye without removing the eye’s natural crystalline lens. This distinguishes an ICL procedure from other refractive procedures, as it does not involve the removal of corneal eye tissue. All of our ICLs are foldable, which allows the surgeon to insert them into the eye through a small incision during minimally invasive surgery. Further, while ICLs are intended to be permanent, our ICLs are reversible lens implants, meaning they can be removed by a doctor if desired.

We market and sell our ICLs for refractive surgery to treat myopia (nearsightedness) as our “EVO” family of lenses. We believe our EVO lenses are an “Evolution in Visual Freedom” designed to provide premium refractive outcomes while optimizing patient comfort. Our EVO family of lenses includes our EVO ICL, EVO+ ICL, and EVO Visian ICL. Our newest offering, EVO Viva, has an extended depth of focus (EDoF) optic, which is designed to treat myopia with presbyopia (age-related loss of ability to focus). We also market and sell an ICL lens to treat hyperopia (farsightedness), which we call our Visian ICL. We make our ICL product offerings available in multiple models, powers and lengths, including some with toric ICL (TICL) versions to correct for astigmatism (blurred vision). Not all of our products are currently available in all markets where we sell ICLs today.

STAAR employs a commercialization strategy that strives for sustainable, profitable growth. Our growth strategy includes making our complete ICL product line available in our existing geographic markets and expanding into attractive markets where we do not sell our products today. In addition, we are focused on driving awareness of the ICL procedure and the clinical benefits of our ICLs, and providing surgeon training, support and education, particularly in our newer markets. Historically, the Company also manufactured and sold intraocular lenses (or “IOLs”) for use in surgery to treat cataracts. As the Company has focused its business and strategy on its ICL product offerings, we have phased out our cataract IOL product line. For the fiscal year ended ~~December~~January 272, ~~2024~~2026, approximately 100% of our net sales were generated from sales of ICLs.

Operations

STAAR has significant operations globally. For the fiscal year ended ~~December~~January 272, ~~2024~~2026, the Company generated 9491% of its reported worldwide revenue from product sales outside the United States. STAAR ~~sells~~products ~~its~~have ~~products~~been sold in more than 7585 countries, with direct distribution (i.e., via STAAR representatives) in Japan, the U.S., Germany, Spain, Singapore, Canada, and the U.K., with a combination of direct distribution and independent distribution (i.e., via distributors and STAAR representatives) in China, Korea, India, France, Benelux, and Italy, and with independent distribution in the remainder of the countries where we sell.

STAAR maintains operational and administrative facilities in the U.S., Switzerland, and Japan. An overview of STAAR’s current global operations and key facilities is as follows:

•

United States. STAAR’s global administrative offices, principal manufacturing, warehouse, and distribution facilities are located in Monrovia, California. We manufacture the raw material for Collamer lenses in our facility in Aliso Viejo, California. STAAR also operates a technology center housing its research and development (R&D) team and labs in Tustin, California. Our corporate headquarters, including our executive offices, our EVO Experience Center, and additional operational facilities, are located in Lake Forest, California.

•

Switzerland. STAAR operates an administrative, distribution, operational and ~~operational~~manufacturing ~~facility~~facilities in Brügg and Nidau, Switzerland under its wholly owned subsidiary, STAAR Surgical AG. We are in the process of expanding our manufacturing capabilities for STAAR’s ICL products in our Nidau, Switzerland facility.

•

Japan. STAAR operates administrative and distribution facilities in Japan under its wholly owned subsidiary, STAAR Japan Inc. (STAAR Japan). STAAR Japan’s administrative facilities are in Tokyo and Osaka, and its distribution facility is in Musashino City, in greater Tokyo.

We also maintain commercial offices in China, Germany, Spain, India, Singapore, and the U.K.

~~Financial~~Termination ~~Information~~of ~~about~~Alcon ~~Segments~~Merger ~~and Geographic Areas~~Agreement

~~100%~~As previously disclosed, on August 4, 2025, STAAR entered into an Agreement and Plan of Merger (the ~~Company’s~~“Merger ~~sales~~Agreement”) ~~are~~with ~~generated~~Alcon ~~from~~Research, ~~the~~LLC, ~~ophthalmic~~a ~~surgical~~Delaware ~~product~~limited ~~segment~~liability company (“Alcon”), and Rascasse Merger Sub, ~~therefore~~Inc., ~~the~~a ~~Company~~Delaware ~~operates~~corporation asand ~~one~~a ~~operating~~wholly ~~segment~~owned ~~for~~direct ~~financial~~subsidiary ~~reporting~~of ~~purposes~~Alcon (“Merger Sub”). The Merger Agreement provided, among other things, that subject to the satisfaction or waiver of the conditions set forth therein, Merger Sub will merge with and into the Company’s ~~principal~~(the ~~products~~“Merger”), ~~are~~with ~~ICLs~~the ~~used~~Company insurviving ~~refractive~~the ~~surgery~~Merger as a wholly owned subsidiary of Alcon. ~~See~~The ~~Note~~Company 16and Alcon entered into two amendments to the ~~Consolidated~~Merger ~~Financial~~Agreement, ~~Statements~~on ~~for~~November ~~financial~~7, ~~information~~2025 ~~about~~and ~~product~~December ~~lines~~9, 2025, and ~~operations~~the inCompany ~~geographic~~held ~~areas.~~a special meeting of stockholders (the “Special Meeting”) to

~~Principal~~vote ~~Products~~on the Merger on January 6, 2026. At the Special Meeting, the Company’s stockholders voted against the Merger, and the Merger Agreement was terminated in accordance with its terms effective January 6, 2026. None of the Company, Alcon or Merger Sub was required to pay any termination fee as a result of the termination of the Merger Agreement, and the parties are responsible for their respective costs and expenses related to the Merger Agreement and the transactions contemplated thereby. During fiscal 2025, we incurred $17.1 million in professional fees and expenses related to the Merger, which are recorded as Merger transaction and related costs on the Consolidated Statement of Operations. Following the termination of the Merger Agreement, on January 14, 2026, STAAR entered into a letter agreement (the “Cooperation Agreement”) with Broadwood Partners, L.P. and its affiliates (“Broadwood”), the Company’s largest stockholder. The Cooperation Agreement provided for certain governance and leadership changes, as well as reimbursement by the Company of expenses incurred by Broadwood and other stockholders in connection with their engagement with the Company, including the Special Meeting. See Note 1 – Organization and Description of Business and Accounting Policies – Termination of Alcon Merger Agreement and Note 19 – Subsequent Events to the Consolidated Financial Statements for information about the Merger Agreement and the Cooperation Agreement.

~~STAAR’s~~Financial ~~principal~~Information ~~products~~about ~~are~~Segments ~~ICLs used in refractive surgery, including our EVO family of lenses. In designing our ICL product offerings, we seek to delight patients~~ and ~~surgeons~~Geographic ~~by:~~Areas

~~Improving~~100% ~~patient~~of ~~outcomes;~~the Company’s sales are generated from the ophthalmic surgical product segment and, therefore, the Company operates as one operating segment for financial reporting purposes. The Company’s principal products are ICLs used in refractive surgery. See Note 17 – Disaggregation of Revenues, Geographic Sales and Product Sales to the Consolidated Financial Statements for financial information about product lines and operations in geographic areas.

~~Minimizing~~Principal ~~patient risk; and~~Products

~~Simplifying~~STAAR’s ~~ophthalmic~~principal ~~procedures~~products ~~and~~are ~~post-operative~~ICLs ~~care~~used ~~for~~in ~~the~~refractive ~~surgeon~~surgery, ~~and~~including ~~the~~our ~~patient~~EVO family of lenses. In designing our ICL product offerings, we seek to delight patients and surgeons by:

•

~~Refractive~~Improving ~~surgery~~patient corrects visual disorders that have traditionally been treated by eyeglasses or contact lenses. The field of refractive surgery includes both lens-based procedures, using products like our ICLs, and laser-based procedures like LASIK. Our ICL products are designed to treat a wide range of refractive conditions within commonly known vision disorders such as myopia (nearsightedness), hyperopia (farsightedness), astigmatism (blurred vision) and presbyopia (age-related loss of ability to focus).outcomes;

•

~~All~~Minimizing of our ICLs fold for minimally invasive implantation. During a quick surgical procedure, the ICL will be implanted behind the iris and in front of the natural crystalline lens, using techniques similar to those used to implant an IOL during cataract surgery, except that the natural lens remains intact in the eye. Lenses of this type are generically called “phakic IOLs” or “phakic implants” because they work along with the patient’s ~~natural~~risk; lens, or phakos, rather than replacing it. The surgeon typically implants the ICL using topical anesthesia on an outpatient basis. The patient usually experiences immediate vision improvement within a day. Typically, ICL surgery is an elective procedure paid for or financed by the patient.and

•

~~Our~~Simplifying ~~EVO~~ophthalmic ~~ICL~~procedures ~~is the only posterior chamber phakic IOL approved by the U.S. Food~~ and ~~Drug~~post-operative ~~Administration~~care ~~(FDA)~~ for ~~marketing and sale in~~ the ~~U.S.,~~surgeon and ~~we believe it is~~ the ~~world’s largest selling phakic IOL~~patient. Our biocompatible Collamer material belongs to a family of materials known as collagen copolymers. Collagen copolymers are compounds formed by joining molecules of collagen derived from biological sources with synthetic monomer molecules. The proprietary Collamer material is exclusive to us. We believe that the biocompatibility of the Collamer material used for our ICL product line is a significant factor in the ability to place this lens safely in the posterior chamber of the eye.

~~STAAR~~Refractive ~~began~~surgery ~~selling~~corrects ~~the~~visual ~~ICL~~disorders ~~for~~that ~~myopia~~have ~~for~~traditionally ~~use~~been ~~outside~~treated ~~the~~by ~~U.S.~~eyeglasses inor ~~1997.~~contact Ulenses.S. ~~sales~~The ~~commenced~~field inof ~~2006.~~refractive Insurgery ~~September~~includes ~~2011,~~both ~~STAAR~~lens-based ~~launched the ICL with CentraFLOW technology~~procedures, ~~commonly~~using ~~known~~products aslike ~~EVO~~our ~~ICL~~ICLs, ~~which~~and ~~uses~~laser-based aprocedures ~~port~~that ininvolve the ~~center~~removal ofor ~~the~~modification ~~ICL optic in markets outside the U.S. The port is~~ of acorneal ~~size intended to optimize the flow of fluid within the~~ eye without affecting the quality of vision. The central port also eliminates the need for the surgeon to perform a YAG peripheral iridotomy procedure days before the ICL implant. The CentraFLOW technology makes the visual outcomes of the ICL available through a relatively quick and comfortable surgical implantation experience. We are authorized to sell the EVO ICL in all countries where we sell our ICL family of lenses. In December 2015tissue, welike ~~received~~LASIK ~~the CE Mark for EVO+, an ICL with CentraFLOW technology~~ and ~~an expanded optical zone of up to 20%~~SMILE. WeOur ~~believe the expanded optical zone may further improve certain patients’ visual experience, thus making the~~ ICL ~~increasingly~~products ~~desirable for both patients and ophthalmic surgeons. We~~ are ~~authorized~~designed to ~~sell~~treat ~~the~~a ~~EVO+~~wide inrange the following regions: the approximately 31 countries that require the European Union CE Mark, Korea, Japan, India, Canada, the U.S., Hong Kong, Turkey, and several countries in the Middle East. In March 2022, the U.S. FDA granted approval of ~~the~~refractive ~~EVO~~conditions ~~ICL,~~within ~~EVO+~~commonly ~~ICL,~~known ~~and~~vision ~~the~~disorders ~~EVO~~such ~~Visian~~as ~~ICL (for the correction of~~ myopia ~~and myopia with astigmatism~~(nearsightedness)., ~~The Visian ICL for~~ hyperopia, ~~which treats~~ (farsightedness), isastigmatism ~~sold~~(blurred ~~primarily~~vision) in countries that require the European Union CE Mark. In July 2020, we received the CE Mark for EVO Viva, a presbyopia-correcting ICL with an aspheric EDoF optic. We commenced certifying surgeons located in countries that recognize the CE Mark to implant the EVO Viva lens. The EVO Viva lens adds near and ~~intermediate vision correction for patients with~~ presbyopia. We(age-related ~~believe~~loss ~~the EVO Viva lens will assist certain patients with eliminating the burdens~~ of ~~reading~~ability ~~glasses~~to ~~or frequent replacement contact lenses~~focus). The launch of EVO ICL and EVO+ ICL have helped drive our growth, and in March 2024, STAAR announced the achievement of a significant milestone for the Company, having sold an aggregate of more than 3,000,000 ICLs worldwide.

WeAll ~~make~~of our ~~ICL~~ICLs ~~product~~fold ~~offerings~~for ~~available~~minimally ininvasive ~~multiple~~implantation. ~~models~~During a quick surgical procedure, ~~powers~~the ICL will be implanted behind the iris and ~~lengths,~~in ~~including~~front ~~some~~of ~~with~~the ~~toric~~natural ~~ICL~~crystalline ~~(TICL)~~lens, ~~versions~~using techniques similar to ~~correct~~those ~~for~~used ~~astigmatism.~~to Asimplant aan ~~result~~IOL during cataract surgery, weexcept ~~manufacture~~that ~~hundreds~~the ofnatural ~~different~~lens ~~types~~remains ofintact ~~lenses~~in the eye. ~~This~~Lenses ~~requires~~of usthis totype ~~carry~~are agenerically ~~significant~~called ~~amount~~“phakic ofIOLs” ~~inventory~~or to“phakic ~~meet~~implants” ~~customer~~because ~~preference~~they ~~for~~work ~~rapid~~along ~~delivery~~with the patient’s natural lens, or phakos, rather than replacing it. We ~~are~~The ~~investing~~surgeon intypically ~~our~~implants ~~manufacturing~~the ~~and~~ICL ~~operations~~using ~~capabilities~~topical toanesthesia beon ~~able~~an tooutpatient ~~meet~~basis. ~~forecasted~~The ~~demand~~patient ~~and~~usually ~~further~~experiences ~~shorten~~immediate ~~lead~~vision ~~times~~improvement within a day. Typically, ICL surgery is an elective procedure paid for or financed by the patient.

4Our EVO ICL is the only posterior chamber phakic IOL approved by the U.S. Food and Drug Administration (FDA) for marketing and sale in the U.S., and we believe it is the world’s largest selling phakic IOL. Our biocompatible Collamer material belongs to a family of materials known as collagen copolymers. Collagen copolymers are compounds formed by joining molecules of collagen derived from biological sources with synthetic monomer molecules. The proprietary Collamer material is exclusive to us. We believe that the biocompatibility of the Collamer material used for our ICL product line is a significant factor in the ability to place this lens safely in the posterior chamber of the eye.

~~According~~STAAR tobegan ~~Market~~selling ~~Scope,~~the ~~LLC~~ICL afor ~~publisher~~myopia offor ~~ophthalmic~~use ~~industry~~outside ~~data,~~the ~~approximately 5~~U.2S. ~~million refractive procedures, primarily laser vision procedures, were expected to be performed worldwide~~ in ~~2024~~1997. ~~The~~U.S. ~~incidence~~sales ofcommenced ~~myopia~~in is growing globally, with high myopia becoming more common according to recently published articles, affecting nearly 5 billion and 1 billion people, respectively, by 2050 (Global Prevalence of Myopia and High Myopia and Temporal Trends from 2000 through 2050, Ophthalmology, Vol2006. ~~123,~~In ~~No.~~September 52011, ~~May~~STAAR ~~2016;~~launched ~~Global~~the ~~trends~~ICL inwith ~~myopia~~CentraFLOW ~~management attitudes and strategies in clinical practice~~technology, ~~Contact~~commonly ~~Lens~~known ~~and~~as ~~anterior~~EVO ~~Eye~~ICL, ~~Vol.~~which ~~39,~~uses ~~2016). We~~a ~~believe~~port ~~this will result~~ in athe ~~significantly~~center ~~increased number~~ of ~~patients seeking refractive procedures. We believe that over~~ the ~~past~~ICL ~~decade~~optic ~~negative~~in ~~publicity~~markets ~~regarding~~outside ~~LASIK has reduced patient interest in~~ the ~~LASIK procedure~~U.S. The ~~ICL~~port is of a ~~lens-based~~size ~~refractive~~intended ~~procedure (unlike LASIK), and STAAR has sold more than 3,000,000 ICLs~~ to ~~date.~~optimize ~~Surgeons~~the ~~have~~flow ~~published hundreds~~ of ~~peer-reviewed~~fluid ~~articles~~within ~~with~~the ~~clinical~~eye ~~data~~without ~~regarding~~affecting the ~~safety, effectiveness, and visual~~ quality of ~~the ICL~~vision. WeThe ~~believe~~central ~~the~~port ~~ICL~~also ~~provides~~eliminates athe ~~safe~~need ~~and effective solution~~ for the ~~growing~~surgeon ~~number~~to ofperform ~~patients~~a ~~with~~YAG ~~refractive~~peripheral ~~conditions~~iridotomy ~~who~~procedure ~~will~~days ~~seek~~before ~~visual~~the ~~freedom~~ICL ~~from~~implant. ~~eyeglasses~~The ~~and~~CentraFLOW ~~contact~~technology ~~lenses.~~makes

We plan to continue to develop and launch innovative products to support clinical needs and to address the increasing demands of our customers. As part of our sales and marketing efforts, we attend and participate in major ophthalmic conventions around the world and invest in market development, practice support, healthcare professional training and patient outreach. We have started working more closely with leading refractive clinics to drive awareness of the ICL procedure and the clinical benefits of our ICLs and to enhance education and practice development. Our marketing programs seek to position our ICL products as a premium and primary option for appropriate patients at the clinic and via digital and social media. We believe that surgeon education and training is critical to the continued adoption of the ICL procedure. In April 2024, we announced the launch of STAAR University, which offers surgeons access to publications, key clinical outcomes data, and other resources to support clinical confidence. In September 2024, we announced the opening of a new EVO Experience Center at our headquarters in Lake Forest, CA, to serve as a hub for comprehensive, hands-on training and education in lens-based vision correction. STAAR offers a comprehensive range of professional education programs to support ophthalmic professionals including wet labs, peer mentorship, and proctorship.4

~~Sales~~the visual outcomes of ~~ICLs~~the ~~accounted~~ICL available through a relatively quick and comfortable surgical implantation experience. We are authorized to sell the EVO ICL in all countries where we sell our ICL family of lenses. In December 2015, we received the CE Mark for ~~approximately~~EVO+, ~~100%~~an ICL with CentraFLOW technology and an expanded optical zone of ~~our~~up ~~total~~to ~~sales~~20%. inWe ~~fiscal~~believe ~~2024~~the expanded optical zone may further improve certain patients’ visual experience, thus making the ICL increasingly desirable for both patients and ophthalmic surgeons. We are authorized to sell the EVO+ in the following regions: the approximately ~~99%~~31 ofcountries ~~our~~that ~~total~~require ~~sales~~the European Union CE Mark, China, Korea, Japan, India, Canada, the U.S., Hong Kong, Turkey, and several countries in ~~fiscal~~the ~~2023~~Middle East. In March 2022, the U.S. FDA granted approval of the EVO ICL, EVO+ ICL, and ~~approximately~~the ~~95%~~EVO Visian ICL (for the correction of myopia and myopia with astigmatism). The Visian ICL for hyperopia, which treats farsightedness, is sold primarily in countries that require the European Union CE Mark. In July 2020, we received the CE Mark for EVO Viva, a presbyopia-correcting ICL with an aspheric EDoF optic. The launch of EVO ICL and EVO+ ICL have helped drive our ~~total~~growth, ~~sales~~and in ~~fiscal~~February ~~2022~~2026, STAAR announced the achievement of a significant milestone for the Company, having sold an aggregate of more than 4,000,000 ICLs worldwide.

~~Other~~We ~~Products~~make our ICL product offerings available in multiple models, powers and lengths, including some with toric ICL (TICL) versions to correct for astigmatism. As a result, we manufacture hundreds of different types of lenses. This requires us to carry a significant amount of inventory to meet customer preference for rapid delivery. We are investing in our manufacturing and operations capabilities to be able to meet forecasted demand and further shorten lead times.

~~While~~According ~~STAAR~~to ~~generates~~Market ~~worldwide~~Scope, ~~revenue~~LLC, ~~almost~~a ~~exclusively~~publisher ~~from sales~~ of ~~our~~ophthalmic ~~ICLs~~industry data, weapproximately ~~also~~4.9 ~~record~~million ~~Other~~refractive ~~Products~~procedures, ~~revenue~~primarily laser vision procedures, ~~which~~were ~~includes~~expected ~~sales~~to be performed worldwide in 2025. The incidence of ~~IOLs~~myopia is growing globally, ~~delivery~~with ~~systems~~high myopia becoming more common according to recently published articles, with myopia and ~~normal~~high ~~recurring~~myopia ~~sales~~affecting ~~adjustments~~nearly ~~such~~5 asbillion ~~sales~~and ~~return~~1 ~~allowances.~~billion ~~Historically~~people, ~~the~~respectively, ~~Company~~by ~~manufactured~~2050 (Global Prevalence of Myopia and ~~sold~~High ~~IOLs~~Myopia ~~for~~and ~~use~~Temporal inTrends ~~surgery~~from to2000 ~~treat~~through ~~cataracts~~2050, asOphthalmology, ~~well~~Vol. as123, ~~injectors~~No. ~~for~~5, ~~use~~May 2016; Global trends in ~~cataract~~myopia ~~surgery~~management attitudes and ~~injector~~strategies ~~parts.~~in ~~Sales~~clinical ~~from~~practice, ~~these~~Contact ~~cataract~~Lens ~~IOLs~~ and ~~other~~anterior ~~surgical~~Eye, ~~products~~Vol. 39, as2016). ~~well~~We asbelieve ~~sales~~this ~~adjustments~~will ~~such~~result asin ~~return~~a ~~allowances,~~significantly ~~are~~increased ~~recorded~~number asof ~~Other~~patients ~~Products~~seeking ~~revenue~~refractive procedures. AsWe believe that over the ~~Company~~past decade negative publicity regarding LASIK has ~~focused~~reduced ~~its~~patient ~~business~~interest ~~and~~in ~~strategy~~the onLASIK ~~its~~procedure. The ICL ~~product~~is ~~offerings,~~a welens-based ~~have~~refractive ~~phased~~procedure ~~out~~(unlike ~~sales~~LASIK), ofand ~~our~~STAAR ~~cataract~~has ~~IOLs~~sold ~~and~~more ~~other~~than ~~surgical~~4,000,000 ~~products~~ICLs to date. WeSurgeons ~~did~~have ~~not~~published ~~record~~hundreds ~~revenue~~of ~~from~~peer-reviewed ~~cataract~~articles ~~IOL~~with ~~sales~~clinical indata ~~fiscal~~regarding ~~2024~~the safety, effectiveness, and wevisual doquality ~~not~~of ~~expect~~the ~~such~~ICL. ~~sales~~We inbelieve the ~~future.~~ICL ~~Other~~provides ~~Products~~a ~~revenue~~safe ~~accounted~~and effective solution for ~~less~~the ~~than~~growing 1%number of ~~our~~patients ~~total~~with ~~sales~~refractive inconditions ~~fiscal~~who ~~2024,~~will seek visual freedom from eyeglasses and ~~approximately~~contact 1%lenses. Further, we believe there is a growing number of ~~our~~patients ~~total~~with ~~sales~~refractive inconditions ~~fiscal~~who ~~2023,~~will seek visual freedom from eyeglasses and ~~approximately~~contact 5%lenses, many of ~~our~~whom ~~total~~are ~~sales~~looking infor ~~fiscal~~alternatives ~~2022~~to laser-based refractive procedures.

~~Sources~~We plan to continue to develop and ~~Availability~~launch innovative products to support clinical needs and to address the increasing demands of ~~Raw~~our ~~Materials~~customers. As part of our sales and marketing efforts, we attend and participate in major ophthalmic conventions around the world and invest in market development, practice support, healthcare professional training and patient outreach. We have started working more closely with leading refractive clinics to drive awareness of the ICL procedure and the clinical benefits of our ICLs and to enhance education and practice development. Our marketing programs seek to position our ICL products as a premium and primary option for appropriate patients at the clinic and via digital and social media. We believe that surgeon education and training is critical to the continued adoption of the ICL procedure. STAAR offers surgeons access to publications, key clinical outcomes data, and other resources to support clinical confidence through STAAR University. In addition, our EVO Experience Center at our headquarters in Lake Forest, California, serves as a hub for comprehensive, hands-on training and education in lens-based vision correction. STAAR offers a comprehensive range of professional education programs to support ophthalmic professionals including wet labs, peer mentorship, and proctorship.

~~STAAR~~Sales ~~uses a wide range~~ of ~~raw~~ICLs ~~materials~~accounted infor ~~the~~approximately ~~production~~100% of our ~~ICLs.~~total ~~STAAR~~sales ~~purchases~~in ~~most~~fiscal of2025, ~~the~~approximately ~~raw~~100% ~~materials and components from external suppliers. Some~~ of our ~~raw~~total ~~materials~~sales ~~are~~in ~~single-sourced~~fiscal ~~due to regulatory constraints~~2024, ~~cost effectiveness, availability, quality,~~ and ~~vendor~~approximately ~~reliability~~99% ~~issues. Many~~ of our ~~components~~total ~~are~~sales ~~standard~~in ~~parts~~fiscal ~~or materials and are available from a variety of sources~~2023. ~~We do not typically pursue regulatory and quality certification of multiple sources of supply.~~

~~Patents,~~Other ~~Trademarks, and Licenses~~Products

WeSTAAR ~~strive~~generates toworldwide ~~protect~~revenue ~~our~~almost ~~investment~~exclusively infrom ~~the~~sales ~~research,~~of ~~development,~~our ~~manufacturing~~ICLs. In prior years, ~~and~~we ~~marketing~~also ofrecorded ~~our~~Other ~~products~~Products ~~through~~revenue, ~~the~~which ~~use~~included sales of ~~patents~~IOLs, ~~trademarks,~~delivery ~~licenses,~~systems ~~trade~~and ~~secrets,~~normal ~~and~~recurring ~~copyrights.~~sales Weadjustments ~~own~~such oras ~~have~~sales ~~rights~~return toallowances. aHistorically, ~~number~~the ofCompany ~~patents,~~manufactured ~~licenses,~~and ~~trademarks,~~sold ~~copyrights,~~IOLs ~~trade~~for ~~secrets,~~use ~~know-how~~in ~~and~~surgery ~~other~~to ~~intellectual~~treat ~~property~~cataracts, ~~related~~as ~~and~~well ~~important~~as toinjectors ~~our~~for ~~business.~~use Asin ofcataract ~~December~~surgery ~~27,~~and ~~2024,~~injector weparts. ~~owned~~Sales ~~approximately~~from 66these ~~United~~cataract ~~States~~IOLs and ~~foreign~~other ~~patents~~surgical ~~and~~products ~~had~~were 21recorded ~~patent~~as ~~applications~~Other ~~pending~~Products revenue. WeAs ~~rely~~the ~~more~~Company onhas ~~trade~~focused ~~secrets~~its ~~than~~business ~~patents~~ and ~~believe~~strategy ~~that~~on noits ~~particular~~ICL ~~patent~~product isofferings, sowe ~~important~~have ~~that~~phased ~~its~~out ~~loss~~sales orof ~~expiration~~our ~~would~~cataract ~~materially~~IOLs ~~adversely~~and ~~affect~~other ~~our~~surgical ~~operations~~products. asWe adid ~~whole.~~not record

Our intellectual property generally relates to the design, production, and manufacture of the Collamer lens material and related materials, ICLs and related lenses, and lens delivery systems for folding intraocular lenses 5

5revenue from cataract IOL sales in fiscal 2025, and we do not expect such sales in the future. Other Products revenue accounted for less than 1% of our total sales in fiscal 2024, and approximately 1% of our total sales in fiscal 2023.

~~(injectors~~Sources and ~~cartridges,~~Availability both stand-alone and preloaded) used with ICLs. We believe it would require extensive time and effort for a competitor to duplicate our intellectual property and processes to develop a product with comparable capabilities to our ICL family of ~~products.~~Raw Materials

~~Worldwide,~~STAAR weuses ~~sell~~a ~~all~~wide range of ~~our~~raw ~~major~~materials ~~products~~in ~~under~~the ~~trademarks~~production weof ~~consider to be important to~~ our ~~business~~ICLs. STAAR®, ~~STAAR~~purchases ~~Surgical™,~~most ~~EVO ICL™, EVO+ ICL™, EVO Visian® ICL™, EVO Viva™, Evolution in Visual Freedom®, Visian®, Collamer®, CentraFLOW®, and AquaPORT®, are trademarks or registered trademarks~~ of ~~STAAR in~~ the ~~U.S.,~~raw ~~the~~materials ~~European Union, or other countries. The scope~~ and ~~duration~~components offrom ~~trademark~~external ~~protection varies widely throughout the world~~suppliers. InSome ~~some countries, trademark protection continues only as long as the mark is used. Other countries require registration~~ of ~~trademarks~~our ~~and~~raw ~~the~~materials ~~payment of registration fees. Trademark registrations~~ are ~~generally~~single-sourced ~~for~~due ~~fixed~~to ~~but~~regulatory ~~renewable~~constraints, ~~terms.~~cost ~~This~~effectiveness, ~~Annual~~availability, ~~Report~~quality, ~~may refer to these~~ and ~~other~~vendor ~~trademarks~~reliability ~~and tradenames~~issues. ~~Solely~~ ~~for~~Many ~~convenience,~~of our ~~trademarks~~components ~~and~~are ~~tradenames~~standard ~~referred~~parts ~~to in this Annual Report may appear without the ®~~ or ™materials ~~symbols,~~and ~~but such references~~ are ~~not~~available ~~intended~~from toa ~~indicate~~variety inof ~~any~~sources. ~~way~~We ~~that~~do ~~we will~~ not ~~assert,~~typically topursue ~~the~~regulatory ~~fullest extent under applicable law, our rights to these trademarks~~ and ~~tradenames.~~quality ~~This~~certification ~~Annual~~of ~~Report~~multiple ~~may~~sources ~~also include trademarks owned by other parties, and all other such trademarks mentioned in this Annual Report are the property~~ of ~~their respective owners~~supply.

~~We protect our proprietary technology~~Patents, ~~in part~~Trademarks, ~~through confidentiality~~ and nondisclosure agreements with employees, consultants, and other parties. Our confidentiality agreements with employees and consultants generally contain standard provisions requiring those individuals to assign to STAAR, without additional consideration, inventions conceived or reduced to practice by them while employed or retained by STAAR, subject to customary exceptions. We cannot provide any assurance that employees and consultants will abide by the confidentiality or other terms of their agreements. Despite measures taken to protect our intellectual property, unauthorized parties may copy aspects of our products or obtain and use information that we regard as proprietary.Licenses

~~Seasonality~~We strive to protect our investment in the research, development, manufacturing, and marketing of our products through the use of patents, trademarks, licenses, trade secrets, and copyrights. We own or have rights to a number of patents, licenses, trademarks, copyrights, trade secrets, know-how and other intellectual property related and important to our business. As of January 2, 2026, we owned approximately 87 United States and foreign patents and had 30 patent applications pending. We rely more on trade secrets than patents and believe that no particular patent is so important that its loss or expiration would materially adversely affect our operations as a whole.

~~While~~Our ~~certain~~intellectual ~~individual~~property ~~markets~~generally ~~may~~relates beto ~~impacted~~the bydesign, ~~seasonal~~production, ~~trends~~and onmanufacture aof ~~quarterly~~the ~~basis~~Collamer lens material and related materials, inICLs ~~the~~and ~~aggregate~~related lenses, ~~seasonality~~and ~~does~~lens ~~not~~delivery ~~materially~~systems ~~affect~~for folding intraocular lenses (injectors and cartridges, both stand-alone and preloaded) used with ICLs. We believe it would require extensive time and effort for a competitor to duplicate our ~~sales~~intellectual property and processes to develop a product with comparable capabilities to our ICL family of products.

~~Working~~Worldwide, ~~Capital~~we ~~Requirements~~sell all of our major products under trademarks we consider to be important to our business. STAAR®, STAAR Surgical™, EVO ICL™, EVO+ ICL™, EVO Visian® ICL™, EVO Viva™, Evolution in Visual Freedom®, Visian®, Collamer®, CentraFLOW®, and AquaPORT®, are trademarks or registered trademarks of STAAR in the U.S., the European Union, or other countries. The scope and duration of trademark protection varies widely throughout the world. In some countries, trademark protection continues only as long as the mark is used. Other countries require registration of trademarks and the payment of registration fees. Trademark registrations are generally for fixed but renewable terms. This Annual Report may refer to these and other trademarks and tradenames. Solely for convenience, our trademarks and tradenames referred to in this Annual Report may appear without the ® or ™ symbols, but such references are not intended to indicate in any way that we will not assert, to the fullest extent under applicable law, our rights to these trademarks and tradenames. This Annual Report may also include trademarks owned by other parties, and all other such trademarks mentioned in this Annual Report are the property of their respective owners.

~~There~~We ~~are~~protect noour ~~special~~proprietary ~~inventory~~technology, ~~requirements~~in part, through confidentiality and nondisclosure agreements with employees, consultants, and other parties. Our confidentiality agreements with employees and consultants generally contain standard provisions requiring those individuals to assign to STAAR, without additional consideration, inventions conceived or ~~credit~~reduced ~~terms~~to ~~extended~~practice by them while employed or retained by STAAR, subject to ~~customers~~customary exceptions. We cannot provide any assurance that ~~have~~employees aand ~~material~~consultants ~~adverse~~will ~~effect~~abide onby the confidentiality or other terms of their agreements. Despite measures taken to protect our ~~working~~intellectual ~~capital~~property, unauthorized parties may copy aspects of our products or obtain and use information that we regard as proprietary.

~~Distribution and Customers~~Seasonality

WeWhile ~~market~~certain ~~our~~individual ~~products~~markets tomay abe ~~variety~~impacted ofby ~~health~~seasonal ~~care~~trends ~~providers,~~on ~~including~~a ~~ophthalmic~~quarterly ~~surgeons~~basis, ~~vision~~in ~~centers,~~the ~~surgical centers~~aggregate, ~~hospitals,~~seasonality ~~government~~does ~~facilities,~~not ~~and~~materially ~~distributors.~~affect ~~Ophthalmologists are the primary users of~~ our ~~products~~sales.

WeWorking ~~sell~~Capital our products directly through our own sales representatives in Japan, the U.S., Germany, Spain, Singapore, Canada, and the U.K. We sell through a combination of our own representatives and independent distributors in China, Korea, India, France, Benelux, and Italy. We sell through independent distributors in other countries. Our products are sold in more than 75 countries worldwide. We maintain a global marketing team, as well as regional marketing personnel to support the promotion and sale of our products. The global marketing department supports selling efforts by developing and providing promotional materials, speakers’ programs, digital and social media sites, participation in trade shows and technical presentations. Where we distribute products directly, we rely on local sales representatives to help generate sales by promoting and demonstrating our products with physicians. Our clinical affairs personnel provide training and educational courses globally.Requirements

~~Two~~There ~~customers,~~are ~~our~~no ~~China~~special ~~distributors~~inventory ~~who~~requirements ~~sell~~or ~~into~~credit ~~China~~terms ~~and~~extended ~~Hong~~to ~~Kong,~~customers ~~accounted~~that ~~for~~have ~~approximately~~a ~~51%~~material ofadverse ~~our~~effect ~~consolidated~~on ~~net sales during fiscal 2024. Net sales to~~ our ~~China~~working ~~distributors during each of the last three fiscal years were as follows:~~ capital.

Net Sales to China Distributors
Fiscal Year	Net Sales($, in thousands)		Net Sales as Percentage of Consolidated Net Sales
2024	$	161,321		51.4	%
2023	$	185,554		57.6	%
2022	$	148,167		52.1	%

Distribution and Customers

6We market our products to a variety of health-care providers, including ophthalmic surgeons, vision centers, surgical centers, hospitals, government facilities, and distributors. Ophthalmologists are the primary users of our products.

Our agreements with our distributors in China provide for minimum inventory requirements based on forecasted demand. These requirements are intended to establish minimum levels of inventory in-country to mitigate potential delays associated with importation and logistics, as well as to establish a sufficient supply of lenses to support quick and efficient delivery and fulfillment for surgical procedures. Our distributors often purchase lenses above the minimums required by their agreements. During fiscal 2024, our distributors purchased lenses above such minimums in anticipation of higher procedural volumes during what is typically a summer “high season” in China. Due to dynamic macroeconomic conditions and other factors, the number of ICL procedures performed during the high season and the second half of 2024 overall was lower than expected. Accordingly, our distributors in China held, as of December 27, 2024, elevated levels of ICL product inventory. Given the size of the Company’s business in China relative to its net sales in the rest of the world, macroeconomic conditions in China have a significant impact on the Company’s business, operations, and financial results. The sluggish economy and weak consumer consumption in China negatively impacted the Company’s financial results for fiscal 2024, and as discussed further in “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” is expected to continue to impact demand for our ICLs in China in fiscal 2025. 6

~~Backlog~~We sell our products directly through our own sales representatives in Japan, the U.S., Germany, Spain, Singapore, Canada, and the U.K. We sell through a combination of our own representatives and independent distributors in China, Korea, India, France, Benelux, and Italy. We sell through independent distributors in other countries. Our products have been sold in more than 85 countries worldwide. We maintain a global marketing team, as well as regional marketing personnel to support the promotion and sale of our products. The global marketing department supports selling efforts by developing and providing promotional materials, speakers’ programs, digital and social media sites, participation in trade shows and technical presentations. Where we distribute products directly, we rely on local sales representatives to help generate sales by promoting and demonstrating our products with physicians. Our clinical affairs personnel provide training and educational courses globally.

WeTwo ~~generally keep sufficient inventory on hand to ship product immediately or shortly after receipt of an order. As we offer different types of ICLs to treat different refractive conditions~~customers, ~~and~~ our ~~ICLs~~China ~~are~~distributors ~~manufactured~~who tosell ~~address~~into ~~refractive~~China ~~prescriptions~~and ~~across~~Hong ~~a broad range of correction~~Kong, weaccounted ~~maintain~~for aapproximately ~~large~~32% ~~number~~ of ~~Stock~~our ~~Keeping~~consolidated ~~Units~~net ~~(SKUs). The~~sales ~~challenge~~during ~~of maintaining inventory in all models can result in a backlog in customer orders. During~~ fiscal 2024, we continued to increase our inventory levels to meet the significant level of anticipated demand for our ICL lenses and to support quick and efficient delivery and fulfillment for surgical procedures2025. ~~Increasing~~Net ~~our~~sales ~~inventory levels also helps mitigate risks associated with potential disruptions~~ to our ~~manufacturing~~China ~~and~~distributors ~~production~~during ~~process.~~each ~~We currently manufacture all~~ of ~~our ICL products at a single facility in Monrovia, California. To mitigate~~ the ~~risk~~last ofthree ~~fire,~~fiscal ~~flood,~~years ~~earthquake,~~were ~~terrorism or other natural or man-made disasters, including manufacturing challenges such~~ as ~~equipment~~follows: or information technology (IT) failure, we have increased our inventory levels. We maintain this inventory at different sites in the United States, Switzerland, and Japan. As of December 27, 2024, finished goods inventory, net was $43.3 million, or 194 Days’ Inventory on Hand (DOH), including consignment inventory.

Government Contracts


Net Sales to China Distributors
Fiscal Year	Net Sales ($, in thousands)		Net Sales as Percentage of Consolidated Net Sales
2025	$	77,781		32.5	%
2024	$	162,287		51.7	%
2023	$	184,569		57.2	%

NoOur ~~material~~agreements ~~portion~~with our distributors in China provide for minimum inventory requirements based on forecasted demand. These requirements are intended to establish minimum levels of ~~our~~inventory ~~business~~in-country isto ~~subject~~mitigate potential delays associated with importation and logistics, as well as to ~~renegotiation~~establish a sufficient supply of ~~profits~~lenses orto ~~termination~~support quick and efficient delivery and fulfillment for surgical procedures. Our distributors often purchase lenses above the minimums required by their agreements. During fiscal 2024, our distributors purchased lenses above such minimums in anticipation of ~~any~~higher ~~particular~~procedural ~~contract~~volumes orduring ~~subcontract~~what atis typically a summer “high season” in China. Due to dynamic macroeconomic conditions and other factors, the ~~election~~number of ICL procedures performed during the Uhigh season and the second half of 2024 overall was lower than expected.S Accordingly, our distributors in China held, as of December 27, 2024, elevated levels of ICL product inventory. ~~Government~~The level of inventory owned by our distributors in China has decreased substantially since December 27, 2024, and has returned to contractual levels. As anticipated, we reported lower China ICL sales in fiscal 2025 compared to fiscal 2024.

~~Competition~~In April 2025, in response to the announcement of tariffs by the United States on Chinese goods, China announced retaliatory tariffs on U.S.-origin goods. In order to mitigate potential financial exposure from such tariffs, we negotiated and implemented consignment agreements with our two distributors in China, and we delivered consigned inventory to China in advance of the implementation of tariffs and delivered additional consignment inventory throughout fiscal 2025. While the tariff situation is evolving, we believe that these efforts to increase the amount of ICLs in China reduce the Company’s tariff risk in China in the near-term. In addition, we are rapidly ramping up our production capabilities in Switzerland to supplement our manufacturing capacity in the United States to provide optionality under multiple tariff scenarios.

~~Competition~~Given that we maintained consigned inventory in ~~the~~China ~~ophthalmic~~in ~~surgical~~2025, ~~product~~purchases ~~market~~by isour ~~intense~~distributors ~~and~~were issatisfied ~~primarily~~in ~~driven~~part byfrom ~~technological~~our ~~innovation~~consigned ~~and~~inventory, ~~the~~rather ~~regulatory~~than ~~approval~~through ~~required~~bulk topurchases. ~~commercialize~~As ~~products~~our inChina ~~the~~distributor ~~key~~inventory ~~markets~~levels ~~around~~have ~~the~~normalized, ~~world.~~we ~~The~~intend ~~development~~to ofreduce ~~new~~our orconsigned ~~improved~~inventory ~~products~~levels ~~may~~in ~~make~~China ~~existing~~going ~~products~~forward. ~~less~~We ~~attractive~~reduced our China inventory levels in 2025, ~~reduce~~and ~~them~~we have taken steps to ~~commodity~~mitigate ~~status~~the orrisk ~~even~~of ~~make~~elevated ~~them~~inventory ~~obsolete.~~buildup Toby ~~remain~~our ~~competitive~~distributors, ~~companies~~while ~~such~~at asthe ~~STAAR~~same ~~must~~time ~~devote~~maintaining ~~continued~~sufficient ~~efforts~~ICL ~~and~~inventory ~~significant~~in ~~financial~~China ~~resources~~ to ~~enhance~~support ~~their~~quick ~~existing~~and ~~products~~efficient delivery and tofulfillment ~~develop~~for ~~new~~surgical ~~products~~procedures.

~~Our~~Given ~~ICL~~the ~~technology~~size ~~competes~~of ~~with~~the ~~other~~Company’s ~~elective~~business ~~surgical~~in ~~procedures~~China ~~such~~relative asto ~~laser~~its ~~vision~~net ~~correction~~sales ~~(e.g.~~in the rest of the world, ~~LASIK)~~macroeconomic ~~for~~conditions ~~those~~in ~~consumers~~China ~~who~~have ~~are~~a ~~looking~~significant ~~for~~impact anon ~~alternative~~the toCompany’s ~~eyeglasses~~business, oroperations, ~~contact~~and ~~lenses~~financial toresults. ~~correct~~The ~~their~~sluggish ~~vision~~economy and weak consumer consumption in China negatively impacted the Company’s financial results for fiscal 2025 and 2024, and as discussed further in “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” is expected to acontinue ~~lesser~~to ~~extent~~impact ~~phakic~~demand ~~lens~~for ~~implants~~our ICLs in China in fiscal 2026.

WeBacklog believe our primary competition in selling the ICL to patients seeking surgery to correct refractive conditions lies not in similar products to the ICL, but in laser surgical procedures. Alcon (formerly a part of Novartis), Johnson & Johnson (formerly Advanced Medical Optics or AMO), Bausch Health Companies (formerly Valeant, Bausch & Lomb or B+L), and Carl Zeiss Meditec AG, all market lasers for corneal refractive surgery and promote their sales worldwide.

~~Phakic~~We ~~implants~~generally ~~that~~keep ~~compete~~sufficient ~~with~~inventory ~~the~~on ~~ICL~~hand ~~are~~to ~~also~~ship ~~available~~product inimmediately ~~the~~or ~~marketplace.~~shortly ~~The~~after ~~two~~receipt ~~principal types~~ of ~~phakic~~an implantable lenses are (1) posterior chamber designs like the ICL, including lenses made by Biotech Vision Care, Care Group, and Eyebright and (2) iris clip anterior chamber designs, including lenses made by Ophtecorder. ~~While~~As ~~most~~we ~~competing~~offer ~~lenses~~different ~~are made from~~ types of ~~silicone or acrylic, we believe our~~ ICLs ~~offer compelling clinical advantages due~~ to ~~our~~treat ~~proprietary~~different ~~Collamer~~refractive ~~lens material~~conditions, ~~as well as their design~~ and ~~features. We also believe~~ our ~~track~~ICLs ~~record of safety and effectiveness, and high levels of patient satisfaction,~~ are ~~competitive~~manufactured ~~advantages relative~~ to ~~laser~~address ~~surgical~~refractive ~~procedures~~prescriptions ~~and~~across ~~other~~a ~~implantable~~broad ~~lenses.~~range ~~Notably,~~of ~~our EVO ICL is the only foldable~~correction, ~~minimally~~we ~~invasive~~maintain ~~posterior~~a ~~chamber~~large ~~phakic~~number ~~intraocular~~of ~~lens~~Stock ~~approved~~Keeping ~~for~~Units ~~sale in the U.S. In addition, competitors from Asia are beginning to~~

~~appear~~(SKUs). The challenge of maintaining inventory in all models can result in a backlog in customer orders. During fiscal 2024, we continued to increase our inventory levels to meet the ~~market~~significant level of anticipated demand for our ICL lenses and to support quick and efficient delivery and fulfillment for surgical procedures. Increasing our inventory levels also helps mitigate risks associated with ~~their~~potential ~~low~~disruptions to our manufacturing and production process. Our principal ICL manufacturing facility is located in Monrovia, California, and in 2025, we expanded our manufacturing capabilities for ICL products in our Nidau, Switzerland facility. To mitigate the risk of fire, flood, earthquake, terrorism or other natural or man-~~cost~~made ~~version~~disasters, including manufacturing challenges such as equipment or information technology (IT) failure, we have increased our inventory levels. We maintain this inventory at different sites in the United States, Switzerland, and Japan. As of aJanuary ~~posterior~~2, ~~chamber~~2026, ~~implantable~~finished ~~contact~~goods ~~lens~~inventory, ~~increasing~~net, which includes consignment inventory, was $39.7 million, or 219 Days’ Inventory on Hand (DOH). DOH is calculated using the ~~level~~first quarter 2026 projected cost of ~~competition~~sales.

~~The~~Government ~~Human Eye~~Contracts

~~The~~No ~~following~~material ~~discussion~~portion ~~provides background information on the structure, function, and some~~ of ~~the~~our ~~disorders~~business ofis ~~the~~subject ~~human eye~~ to ~~enhance~~renegotiation ~~the reader’s understanding~~ of ~~our~~profits ~~products~~or ~~described~~termination ~~in this Annual Report. The human eye is a specialized sensory organ capable~~ of ~~receiving~~any ~~visual~~particular ~~images~~contract ~~and~~or ~~transmitting~~subcontract ~~them~~at to the ~~visual~~election ~~center~~of in the ~~brain~~U.S. ~~The eye has an anterior segment and a posterior segment that are separated by the natural crystalline lens~~Government.

The anterior segment consists of the cornea, the iris and ciliary body and the trabecular meshwork. It is filled with a water-based fluid called aqueous humor and is divided, by the iris, into an anterior chamber and a posterior chamber. The cornea is a clear lens at the front of the eye through which light first passes and is focused toward the back of the eye. The interior surface of the cornea is lined with a single layer of flat, tile-like endothelial cells, whose function is to maintain the transparency of the cornea. The iris is a pigmented muscular curtain located behind the cornea which opens and closes to regulate the amount of light entering the eye through the pupil, an opening at the center of the iris. The crystalline lens, located behind the iris, completes the focusing of light and can change shape to focus objects at different distances onto the retina, located in the back of the eye. The trabecular meshwork, a drainage channel located between the iris and the surrounding white portion of the eye, maintains a normal pressure in the anterior chamber of the eye by draining excess aqueous humor.Competition

~~The~~Competition ~~posterior~~in ~~segment~~the ofophthalmic ~~the~~surgical ~~eye~~product ~~that~~market is ~~behind~~intense ~~the~~and ~~natural~~is ~~lens~~primarily isdriven ~~filled~~by ~~with~~technological ainnovation ~~jelly-like~~and ~~material~~the ~~called~~regulatory approval required to commercialize products in the ~~vitreous~~key ~~humor~~markets around the world. The ~~retina~~development isof anew ~~layer~~or ofimproved ~~nerve~~products ~~tissue~~may inmake ~~the~~existing ~~back~~products ofless ~~the~~attractive, ~~eye~~reduce ~~consisting~~them ofto ~~millions~~commodity ofstatus ~~light~~or ~~receptors~~even ~~called~~make ~~rods~~them ~~and~~obsolete. ~~cones~~To remain competitive, ~~which~~companies ~~receive~~such ~~the~~as ~~light~~STAAR ~~image~~must devote continued efforts and ~~transmit~~significant itfinancial resources to ~~the~~enhance ~~brain~~their ~~via~~existing ~~the~~products ~~optic~~and ~~nerve~~to develop new products.

~~Common~~Our ~~visual~~ICL ~~disorders,~~technology ~~disease~~competes orwith ~~trauma~~other ~~can~~elective ~~affect~~surgical ~~the~~procedures ~~eye.~~such ~~One~~as oflaser ~~the~~vision ~~most~~correction ~~prevalent~~(e.g., ~~ocular~~LASIK ~~disorders~~and isSMILE) ~~cataracts.~~for ~~Cataract~~those ~~formation~~consumers iswho ~~generally~~are looking for an ~~age-related~~alternative ~~disorder~~to ~~that~~eyeglasses ~~involves~~or ~~the~~contact ~~hardening~~lenses to correct their vision, and ~~loss~~to ofa ~~transparency~~lesser ofextent ~~the~~phakic lens implants, including refractive lens exchange (RLE) procedures, where a patient’s natural crystalline lens, ~~impairing~~is ~~visual~~removed ~~acuity~~and replaced with an artificial lens.

~~Refractive~~We ~~disorders,~~believe ~~which~~our ~~generally~~primary ~~are~~competition ~~not~~in ~~age-related,~~selling ~~include myopia, hyperopia, and astigmatism. A normal, well-functioning eye receives images of objects at varying distances from~~ the ~~eye~~ICL ~~and~~to ~~focuses~~patients ~~the~~seeking ~~images~~surgery onto ~~the~~correct ~~retina.~~refractive ~~Refractive~~conditions ~~errors~~lies ~~occur when the eye’s natural optical system does~~ not ~~properly~~in ~~focus~~similar anproducts ~~image~~to on the ~~retina. Myopia~~ICL, ~~also~~but ~~known~~in aslaser ~~nearsightedness,~~surgical ~~occurs~~procedures. ~~when~~Alcon ~~the~~(formerly ~~eye’s~~a ~~lens~~part ~~focuses images in front~~ of ~~the retina. Hyperopia~~Novartis), orJohnson ~~farsightedness,~~& ~~occurs~~Johnson ~~when~~(formerly ~~the~~Advanced ~~eye’s~~Medical ~~lens~~Optics ~~focuses images behind the plane of the retina. Individuals with myopia~~ or ~~hyperopia~~AMO), ~~may~~Bausch ~~also~~Health ~~have~~Companies ~~astigmatism.~~(formerly ~~Astigmatism~~Valeant, isBausch ~~due~~& toLomb ~~an irregular curvature of the cornea~~ or ~~defects~~B+L), inand ~~the~~Carl ~~natural~~Zeiss ~~lens~~Meditec ~~that~~AG, ~~causes~~all ~~light~~market tolasers ~~not~~for ~~focus~~corneal ~~at a single depth in the eye resulting in blurred vision. Presbyopia is an age-related~~ refractive ~~disorder~~surgery ~~that limits a person’s ability to see in the near~~ and ~~middle-distance~~promote ~~range~~their assales ~~the natural crystalline lens loses its elasticity, reducing the eye’s ability to accommodate or adjust its focus for varying distances~~worldwide.

~~Regulatory~~Phakic ~~Matters~~implants that compete with the ICL are also available in the marketplace. The two principal types of phakic implantable lenses are (1) posterior chamber designs like the ICL, including lenses made by Biotech Vision Care, Care Group, and Eyebright and (2) iris clip anterior chamber designs, including lenses made by Ophtec. While most competing lenses are made from types of silicone or acrylic, we believe our ICLs offer compelling clinical advantages due to our proprietary Collamer lens material, as well as their design and features. We also believe our track record of safety and effectiveness, and high levels of patient satisfaction, are competitive advantages relative to laser surgical procedures and other implantable lenses. Notably, our EVO ICL is the only foldable, minimally invasive posterior chamber phakic intraocular lens approved for sale in the U.S. In addition, competitors from Asia are beginning to appear in the market with their low-cost version of a posterior chamber implantable contact lens, increasing the level of competition, and we are aware that other companies are developing competitive products that have not yet been brought to market.

~~Nearly~~The ~~all~~Human countries where we sell our products have regulations requiring premarket clearance or approval of medical devices by governmental or regulatory authorities. Various federal, state, local and foreign laws also apply to our operations, including, among other things, working conditions, laboratory, clinical, advertising and promotions, and design and manufacturing practices, and the use and disposal of hazardous or potentially hazardous substances.Eye

The ~~requirements~~following ~~for~~discussion ~~clearance~~provides orbackground ~~approval~~information toon ~~market medical products vary widely by country. The requirements range from minimal requirements to rigorous requirements comparable to those established by~~ the ~~U.S. FDA. Obtaining clearance or approval to distribute medical products is complex~~structure, ~~costly~~function, and ~~time-consuming~~some inof ~~virtually all~~ the ~~major~~disorders ~~markets~~of ~~where~~the wehuman ~~sell~~eye ~~medical~~to ~~devices.~~enhance Wethe ~~cannot~~reader’s ~~give~~understanding ~~any~~of ~~assurance that any new medical devices we develop will be cleared or approved in any country where we propose to sell~~ our ~~medical~~products ~~devices~~described ~~or, if approved, whether such approvals will be granted~~ in athis ~~timely~~Annual ~~or cost-effective manner, be as broad in scope as we seek, or be conditioned on post-market study requirements or restrictive labeling~~Report. WeThe ~~also~~human ~~cannot~~eye ~~give~~is ~~any assurance that if our medical devices are approved for sale in~~ a ~~country,~~specialized ~~subsequent~~sensory ~~action~~organ ~~will~~capable ~~not~~of bereceiving ~~taken~~visual byimages ~~the~~and ~~responsible~~transmitting ~~regulatory~~them ~~authorities in the country with respect~~ to ~~our medical devices that might affect our ability to maintain~~ the ~~required~~visual ~~approvals~~center in the ~~country or to continue to sell our medical devices in the country~~brain. The ~~regulatory~~eye ~~requirements~~has inan ~~our~~anterior ~~most~~segment ~~important~~and ~~current~~a ~~markets,~~posterior ~~China,~~segment ~~Europe,~~that ~~Japan,~~are ~~Korea~~separated ~~and~~by the ~~U.S.,~~natural ~~are~~crystalline ~~discussed below~~lens.

~~Medical~~The ~~Device~~anterior ~~Regulations~~segment inconsists of the ~~United~~cornea, ~~States~~the iris and ciliary body and the trabecular meshwork. It is filled with a water-based fluid called aqueous humor and is divided, by the iris, into an anterior chamber and a posterior chamber. The cornea is a clear lens at the front of the eye through which light first passes and is focused toward the back of the eye. The interior surface of the cornea is lined with a single layer of flat, tile-like endothelial cells, whose function is to maintain the transparency of the cornea. The iris is a pigmented muscular curtain located behind the cornea which opens and closes to regulate the amount of light entering the eye through the pupil, an opening at the center of the iris. The crystalline lens, located behind the iris, completes the focusing of light and can change shape to focus objects at

Under the United States Federal Food, Drug & Cosmetic Act, as amended (the Act), the FDA has the authority to regulate, among other things, the design, development, manufacturing, preclinical and clinical testing, labeling, 8

8different distances onto the retina, located in the back of the eye. The trabecular meshwork, a drainage channel located between the iris and the surrounding white portion of the eye, maintains a normal pressure in the anterior chamber of the eye by draining excess aqueous humor.

~~product~~The ~~safety,~~posterior ~~marketing,~~segment ~~sales,~~of ~~distribution,~~the ~~premarket~~eye ~~clearance~~that ~~and~~is ~~approval,~~behind ~~recordkeeping,~~the ~~reporting,~~natural ~~advertising,~~lens ~~promotion,~~is ~~post~~filled with a jelly-~~market~~like ~~surveillance,~~material called the vitreous humor. The retina is a layer of nerve tissue in the back of the eye consisting of millions of light receptors called rods and ~~import~~cones, which receive the light image and ~~export~~transmit ofit ~~medical~~to ~~devices~~the brain via the optic nerve.

~~Most~~Common visual disorders, disease or trauma can affect the eye. One of ~~our~~the ~~products~~most ~~are~~prevalent ~~classified~~ocular asdisorders ~~medical~~is ~~devices~~cataracts. ~~intended~~Cataract ~~for~~formation ~~human~~is ~~use~~generally ~~within~~an ~~the~~age-related ~~meaning~~disorder ofthat involves the ~~Act~~hardening and, ~~therefore,~~loss ~~are~~of ~~subject~~transparency toof ~~FDA~~the ~~regulation~~natural crystalline lens, impairing visual acuity.

~~Each~~Refractive ~~medical~~disorders, ~~device~~which wegenerally ~~seek~~are tonot ~~commercially~~age-related, ~~distribute~~include inmyopia, ~~the~~hyperopia, ~~United~~and ~~States~~astigmatism. ~~must~~A ~~first~~normal, ~~receive~~well-functioning ~~clearance~~eye toreceives ~~market~~images ~~under~~of aobjects ~~notification~~at ~~submitted~~varying ~~pursuant~~distances tofrom ~~Section 510(k) of~~ the ~~Act,~~eye ~~known~~and asfocuses the ~~510(k)~~images ~~premarket~~on ~~notification, or premarket approval (PMA) from~~ the ~~FDA,~~retina. ~~unless~~Refractive ~~specifically~~errors ~~exempted~~occur bywhen the ~~agency~~eye’s ornatural ~~subject~~optical tosystem ~~another~~does ~~form~~not ofproperly ~~FDA~~focus ~~premarket~~an ~~review.~~image ~~The~~on ~~FDA~~the ~~classifies all medical devices into one of three classes~~retina. ~~The~~Myopia, ~~FDA~~also ~~establishes~~known ~~procedures~~as ~~for~~nearsightedness, ~~compliance~~occurs ~~based~~when ~~upon~~ the ~~device~~eye’s ~~classification~~lens asfocuses ~~Class~~images Iin ~~(general~~front ~~controls,~~of ~~such~~the asretina. ~~establishment registration and device listing with FDA~~Hyperopia, ~~labeling~~or ~~and record-keeping requirements)~~farsightedness, ~~Class~~occurs IIwhen ~~(performance~~the ~~standards~~eye’s inlens ~~addition~~focuses toimages ~~general~~behind ~~controls)~~the orplane ~~Class~~of ~~III~~the ~~(PMA required before commercial marketing)~~retina. ~~Devices~~Individuals ~~deemed~~with tomyopia ~~pose~~or ~~lower~~hyperopia ~~risk~~may ~~are~~also ~~categorized~~have ~~as either Class I (low risk) or II (moderate risk)~~astigmatism. ~~Manufacturers~~Astigmatism ofis ~~Class~~due ~~II devices are generally required~~ to ~~submit~~an toirregular ~~the~~curvature ~~FDA a 510(k) premarket notification requesting clearance~~ of the ~~device~~cornea ~~for~~or ~~commercial~~defects ~~distribution~~ in the ~~United~~natural ~~States.~~lens ~~Most~~that ~~low~~causes ~~risk~~light ~~(Class~~to I)not ~~devices~~focus ~~and~~at ~~some~~a ~~Class~~single IIdepth ~~devices~~in ~~are exempt from this requirement. The FDA deems Class III devices to pose~~ the ~~greatest~~eye ~~risk~~resulting ~~and~~in ~~are~~blurred ~~the most extensively regulated~~vision. ~~These~~Presbyopia ~~devices~~is ~~include~~an ~~life~~age-~~supporting,~~related ~~life~~refractive ~~sustaining,~~disorder orthat ~~implantable~~limits ~~devices, or devices deemed not substantially equivalent to~~ a ~~previously~~person’s ~~510(k)~~ability ~~cleared device. The effect of assigning a device~~ to ~~Class~~see ~~III~~in isthe tonear ~~require~~and ~~each~~middle-distance ~~manufacturer~~range toas ~~submit to~~ the ~~FDA~~natural acrystalline ~~PMA~~lens ~~that~~loses ~~includes~~its ~~information~~elasticity, onreducing the ~~safety~~eye’s ~~and~~ability ~~effectiveness~~to ofaccommodate ~~the~~or ~~device.~~adjust ~~The FDA reviews device applications and notifications through~~ its ~~Office~~focus offor ~~Device~~varying ~~Evaluation (ODE)~~distances.

~~510(k)~~Regulatory Clearance. Our lens injector systems are Class I devices subject to the 510(k) premarket review and clearance process. A medical device that is substantially equivalent to either a previously-cleared medical device or a device that was in commercial distribution before May 28, 1976 for which the FDA has not yet called for the submission of a PMA, or is a device that has been reclassified from Class III to either Class II or I may be eligible for the FDA’s 510(k) premarket notification process. FDA clearance under Section 510(k) of the Act does not imply that the safety, reliability, and effectiveness of the medical device has been approved or validated by the FDA. The review period and FDA determination as to substantial equivalence generally takes from three to twelve months from the date the application is submitted and filed. However, the process may take significantly longer, and clearance is never assured. Although many 510(k) premarket notifications are cleared without clinical data, in some cases, the FDA requires significant clinical data to support substantial equivalence. In reviewing a premarket notification, the FDA may request additional information including clinical data, which may significantly prolong the review process.Matters

~~After~~Nearly aall ~~device~~countries ~~receives~~where ~~510(k)~~we ~~clearance,~~sell ~~any~~our ~~modification~~products ~~that~~have ~~could~~regulations ~~significantly~~requiring ~~affect~~premarket ~~its~~clearance ~~safety~~ or ~~effectiveness,~~approval orof ~~that~~medical ~~would~~devices ~~constitute~~by agovernmental ~~major change in its intended use, will require a new 510(k) clearance~~ or ~~could~~regulatory ~~require premarket approval~~authorities. ~~The~~Various ~~FDA~~federal, ~~requires~~state, ~~each~~local ~~manufacturer~~and toforeign ~~make~~laws ~~its~~also ~~own~~apply ~~initial determination as~~ to ~~whether~~our aoperations, ~~change~~including, ~~meets~~among ~~this~~other ~~threshold. However~~things, ~~the~~working ~~FDA~~conditions, ~~can~~laboratory, ~~review~~clinical, ~~any~~advertising ~~such~~and ~~decision~~promotions, and ~~can~~design ~~disagree~~and ~~with~~manufacturing ~~a manufacturer’s determination. If the FDA disagrees with a manufacturer’s determination~~practices, ~~the~~and ~~FDA can require~~ the ~~manufacturer~~use toand ~~cease~~disposal ~~marketing~~of orhazardous ~~recall the modified device until 510(k) clearance~~ or apotentially ~~PMA~~hazardous ~~is obtained~~substances.

~~Premarket~~The ~~Approval.~~requirements ~~Our~~for ~~ICL~~clearance or approval to market medical products ~~are~~vary ~~Class~~widely ~~III~~by ~~devices~~country. ~~subject~~The requirements range from minimal requirements to rigorous requirements comparable to those established by the ~~PMA~~U.S. FDA. Obtaining clearance or approval ~~process~~to distribute medical products is complex, costly, and ~~not~~time-consuming ~~510(k)~~in ~~clearance. The~~virtually ~~more~~all ~~rigorous~~the ~~PMA~~major ~~process~~markets ~~requires~~where uswe tosell ~~demonstrate~~medical devices. We cannot give any assurance that aany new medical ~~device~~devices iswe ~~safe~~develop ~~and~~will be cleared or approved in any country where we propose to sell our medical devices or, if approved, whether such approvals will be granted in a timely or cost-effective ~~for~~manner, ~~its~~be ~~intended~~as ~~use~~broad in scope as we seek, or be conditioned on post-market study requirements or restrictive labeling. ~~The~~We ~~FDA~~also ~~may~~cannot ~~require~~give any assurance that if our medical devices are approved for sale in a ~~PMA~~country, subsequent action will not be ~~supported~~taken by, ~~among~~the ~~other~~responsible ~~things,~~regulatory ~~extensive~~authorities ~~technical,~~in ~~pre-clinical,~~the ~~clinical~~country ~~testing,~~with ~~manufacturing,~~respect ~~and~~to ~~labeling~~our ~~data~~medical devices that might affect our ability to ~~demonstrate~~maintain the required approvals in the country or to continue to sell our medical devices in the ~~FDA’s~~country. ~~satisfaction~~The regulatory requirements in our most important current markets, ~~the~~China, ~~safety~~Europe, ~~and~~Japan, ~~effectiveness~~Korea ofand the ~~device~~U.S., are discussed below.

~~After~~Medical aDevice ~~PMA~~Regulations ~~application is submitted and filed, the FDA begins an~~ in~~-depth~~ ~~review of~~ the ~~submitted~~United ~~information, which typically takes between six and twelve months, but may take significantly longer depending on the questions received from the FDA regarding the application~~States. During the review period, the FDA may request additional information or clarification of information already provided. In addition to its own review, the FDA may organize an independent advisory panel of experts to review the PMA whenever a device is the first of its kind or the FDA otherwise determines panel review is warranted. The FDA holds panels on a regular basis, but the need to schedule panel review usually adds some weeks or months to the review process. In addition, the FDA will conduct a pre-approval inspection of the manufacturing facility to ensure compliance with Quality System Regulation (QSR) which imposes elaborate design, development, testing, control, validation, documentation, complaint handling, supplier control, and other quality assurance procedures in the design and manufacturing process. The FDA may approve a PMA application with post-approval conditions intended to ensure the safety and effectiveness of the device including, among other things, restrictions on labeling, promotion, sale and distribution and conduct of additional post-approval clinical studies or collection of long-term follow-up from patients in the clinical study that supported approval. Failure

9Under the United States Federal Food, Drug & Cosmetic Act, as amended (the Act), the FDA has the authority to regulate, among other things, the design, development, manufacturing, preclinical and clinical testing, labeling, product safety, marketing, sales, distribution, premarket clearance and approval, recordkeeping, reporting, advertising, promotion, post-market surveillance, and import and export of medical devices.

toMost ~~comply~~of ~~with~~our ~~the~~products ~~conditions~~are ofclassified ~~approval~~as ~~can~~medical ~~result~~devices inintended ~~materially~~for ~~adverse~~human ~~enforcement~~use ~~action,~~within ~~including~~the meaning of the ~~loss~~Act orand, ~~withdrawal~~therefore, ofare ~~the~~subject ~~approval~~to FDA regulation.

IfEach amedical ~~manufacturer~~device ~~plans~~we seek to ~~make~~commercially ~~significant~~distribute ~~modifications~~in the United States must first receive clearance to ~~the~~market ~~manufacturing~~under ~~process~~a notification submitted pursuant to Section 510(k) of the Act, ~~labeling~~known as the 510(k) premarket notification, or ~~design~~premarket ofapproval an(PMA) ~~approved~~from ~~PMA~~the ~~device~~FDA, unless specifically exempted by the ~~manufacturer~~agency ~~must~~or ~~submit~~subject anto ~~application~~another ~~called~~form aof ~~“PMA~~FDA ~~Supplement”~~premarket ~~regarding~~review. ~~the~~The ~~change~~FDA classifies all medical devices into one of three classes. The FDA ~~generally~~establishes ~~reviews~~procedures ~~PMA~~for ~~Supplements~~compliance onbased aupon ~~180-day~~the ~~agency~~device’s ~~timetable,~~classification ~~which~~as ~~may~~Class beI ~~extended~~(general ifcontrols, ~~significant~~such ~~questions~~as ~~arise~~establishment inregistration ~~review~~and ofdevice ~~the~~listing ~~supplement.~~with AFDA, ~~manufacturer~~labeling ~~may~~and ~~implement~~record-keeping ~~limited~~requirements), ~~changes~~Class ~~prior~~II (performance standards in addition to ~~the~~general ~~FDA’s~~controls) ~~review~~or ofClass aIII (PMA ~~Supplement~~required before commercial marketing). ~~The~~Devices ~~FDA~~deemed ~~designates~~to ~~some~~pose ~~PMA~~lower ~~Supplements~~risk are categorized as ~~“panel-track”~~either ~~supplements,~~Class ~~which~~I ~~means~~(low ~~that~~risk) or II (moderate risk). Manufacturers of Class II devices are generally required to submit to the ~~agency~~FDA ~~believes~~a ~~review~~510(k) bypremarket annotification ~~advisory~~requesting ~~panel~~clearance ~~may~~of bethe ~~warranted~~device for commercial distribution in the United States. ~~Designation~~Most aslow arisk ~~panel-track~~(Class ~~supplement~~I) ~~does~~devices ~~not~~and ~~necessarily~~some ~~mean~~Class ~~that~~II ~~panel~~devices ~~review~~are ~~will~~exempt ~~occur~~from this requirement. The FDA deems Class III devices to pose the greatest risk and are the most extensively

Clinical or Market Trials. A clinical trial is typically required to support a PMA application and is sometimes required for a 510(k) premarket notification. Clinical trials conducted to support premarket clearance or approval generally require submission of an application for an Investigational Device Exemption (IDE) to the FDA. Appropriate data must support the IDE application, such as animal and laboratory testing results, showing that it is safe to test the device in humans and that the investigational protocol is scientifically sound. The IDE application must be approved by the FDA for a specified number of patients, unless the product is deemed eligible for more abbreviated IDE requirements. Clinical trials for a significant risk device may begin once the FDA approves the IDE application. All FDA-regulated clinical studies, whether significant or non-significant risk, must be approved and overseen by the appropriate institutional review boards (IRBs) for each clinical trial, and informed consent of the patients participating in the clinical trial must be obtained. After a trial begins, the FDA may place it on hold or terminate it, if, among other reasons, it concludes that the clinical subjects are exposed to an unacceptable health risk. Any trials we conduct in the United States must be conducted in accordance with FDA regulations as well as other federal regulations and state laws concerning human subject protection and privacy. Moreover, the results of a clinical trial may not be sufficient to obtain clearance or approval of the product.9

~~Oversight~~regulated. ofThese ~~compliance~~devices ~~with~~include ~~quality~~life-supporting, ~~medical~~life ~~device reporting~~sustaining, ~~clinical~~or ~~study~~implantable devices, ~~and~~or ~~other~~devices ~~regulations.~~deemed ~~Both~~not ~~before~~substantially ~~and~~equivalent ~~after~~to ~~we receive premarket clearance or approval and release~~ a ~~product~~previously ~~commercially,~~510(k) wecleared ~~have ongoing responsibilities under FDA regulations~~device. The ~~FDA~~effect ~~reviews~~of ~~design~~assigning ~~and~~a ~~manufacturing~~device ~~practices,~~to ~~labeling~~Class ~~and~~III ~~record~~is ~~keeping,~~to ~~product~~require ~~complaints~~each ~~and~~ manufacturer’s ~~required reports of adverse experiences, product corrections and removals, and other information~~ to ~~identify~~submit ~~potential problems with marketed medical devices. We are also subject~~ to ~~periodic~~the ~~inspection~~FDA bya ~~the~~PMA ~~FDA~~that ~~for~~includes ~~compliance~~information ~~with~~on the ~~FDA’s~~safety ~~QSR~~ and ~~other~~effectiveness ~~requirements,~~of ~~such~~the ~~as requirements for advertising and promotion~~device. The ~~Good~~FDA ~~Manufacturing~~reviews ~~Practice~~device ~~(GMP)~~applications ~~regulations for medical devices embodied in the QSR govern the methods used in,~~ and ~~the~~notifications ~~facilities~~through ~~and~~its ~~controls~~Center ~~used~~ for, ~~the~~Devices ~~design, manufacture, packaging, labeling,~~ and ~~servicing~~Radiological ofHealth ~~all finished medical devices intended for human use~~(CDRH).

~~The~~510(k) Clearance. Our lens injector systems are Class I devices subject to the 510(k) premarket review and clearance process. A medical device that is substantially equivalent to either a previously-cleared medical device or a device that was in commercial distribution before May 28, 1976 for which the FDA has not yet called for the submission of a PMA, or is a device that has been reclassified from Class III to either Class II or I may be eligible for the FDA’s ~~Bioresearch~~510(k) ~~Monitoring~~premarket ~~Program~~notification process. FDA clearance under Section 510(~~BIMO~~k), ~~reviews~~of ~~our~~the ~~activities~~Act asdoes anot ~~sponsor~~imply that the safety, reliability, and effectiveness of ~~clinical~~the ~~research~~medical device has been approved or validated by the FDA. ~~BIMO~~The ~~conducts~~review ~~facilities~~period ~~inspections~~and FDA determination as ~~part~~to ofsubstantial aequivalence ~~program~~generally ~~designed~~takes from three to ~~ensure~~twelve ~~that~~months ~~data~~from ~~and~~the ~~information~~date ~~contained~~the inapplication ~~requests~~is ~~for~~submitted ~~IDEs~~and filed. However, ~~PMA~~the ~~applications~~process may take significantly longer, and clearance is never assured. Although many 510(k) ~~submissions~~premarket notifications are ~~scientifically~~cleared ~~valid~~without clinical data, ~~reliable~~in some cases, ~~and~~the ~~accurate~~FDA requires significant clinical data to support substantial equivalence. ~~Another~~In ~~objective~~reviewing ofa ~~the~~premarket ~~program~~notification, isthe toFDA ~~ensure~~may ~~that~~request ~~human~~additional ~~subjects~~information ~~are~~including ~~protected~~clinical ~~from~~data, ~~undue~~which ~~hazard~~may orsignificantly ~~risk~~prolong ~~during~~the ~~scientific~~review ~~investigations~~process.

IfAfter ~~the~~a ~~FDA~~device ~~were~~receives to510(k) ~~conclude~~clearance, ~~that~~any wemodification ~~are~~that ~~not~~could insignificantly ~~compliance~~affect ~~with~~its ~~applicable~~safety ~~laws~~ or ~~regulations~~effectiveness, or that ~~any~~would ofconstitute ~~our~~a ~~medical~~major ~~devices~~change ~~are~~in ~~ineffective~~its orintended ~~pose an unreasonable health risk~~use, ~~the~~will ~~FDA could~~ require ~~us to notify health professionals and others that the devices present unreasonable risk or substantial harm to public health, order~~ a ~~recall,~~new repair, replacement, or refund of the devices, detain, or seize adulterated or misbranded medical devices, or ban the medical devices. The FDA may also issue warning letters or untitled letters, refuse our request for 510(k) clearance or ~~PMA~~could ~~approval,~~require ~~revoke~~premarket ~~existing~~approval. ~~510(k)~~The ~~clearances~~FDA orrequires ~~PMA~~each ~~approvals~~manufacturer ~~previously~~to ~~granted,~~make ~~impose~~its ~~operating~~own ~~restrictions,~~initial ~~enjoin,~~determination ~~and~~as ~~restrain certain violations of applicable law pertaining~~ to ~~medical~~whether ~~devices~~a ~~and~~change ~~assess~~meets ~~civil~~this orthreshold. ~~criminal penalties against our officers~~However, ~~employees,~~the orFDA ~~us.~~can ~~The~~review ~~FDA~~any ~~may~~such ~~also~~decision ~~recommend~~and ~~prosecution~~can todisagree ~~the~~with ~~Department~~a ofmanufacturer’s ~~Justice~~determination. InIf the ~~case~~FDA ofdisagrees ~~devices~~with ~~subject~~a tomanufacturer’s ~~pending premarket clearance or approval applications~~determination, ~~FDA has broad authority to halt~~ the ~~review~~FDA ofcan ~~applications and~~ require ~~significant~~the ~~additional~~manufacturer ~~data analyses, audits, and other corrective actions where clinical data contained in an application are deemed~~ to becease ~~actually~~marketing or ~~potentially~~recall ~~unreliable,~~the ~~inaccurate,~~modified ordevice ~~not~~until in510(k) ~~compliance~~clearance ~~with clinical study~~ or ~~good~~a ~~clinical~~PMA ~~practice~~is ~~requirements~~obtained.

~~Healthcare~~Premarket ~~Fraud~~Approval. Our ICL products are Class III devices subject to the PMA approval process and ~~Abuse~~not ~~Laws~~510(k) clearance. The more rigorous PMA process requires us to demonstrate that a new medical device is safe and ~~Regulations~~effective infor its intended use. The FDA may require that a PMA be supported by, among other things, extensive technical, pre-clinical, clinical testing, manufacturing, and labeling data to demonstrate to the ~~United~~FDA’s ~~States~~satisfaction, the safety and effectiveness of the device.

~~Even~~After ~~though~~a wePMA doapplication ~~not~~is ~~control~~submitted ~~referrals~~and filed, the FDA begins an in-depth review of ~~healthcare~~the ~~services~~submitted information, which typically takes between six and twelve months, but may take significantly longer depending on the questions received from the FDA regarding the application. During the review period, the FDA may request additional information or ~~bill~~clarification ~~directly~~of information already provided. In addition to ~~Medicare~~its own review, ~~Medicaid~~the FDA may organize an independent advisory panel of experts to review the PMA whenever a device is the first of its kind or ~~other~~the ~~third~~FDA otherwise determines panel review is warranted. The FDA holds panels on a regular basis, but the need to schedule panel review usually adds some weeks or months to the review process. In addition, the FDA will conduct a pre-~~party~~approval ~~payers~~inspection of the manufacturing facility to ensure compliance with Quality System Regulation (QSR) which imposes elaborate design, ~~certain~~development, ~~federal~~testing, ~~state~~control, validation, documentation, complaint handling, supplier control, and ~~international~~other ~~healthcare~~quality ~~laws~~assurance procedures in the design and ~~regulations~~manufacturing ~~pertaining~~process. The FDA may approve a PMA application with post-approval conditions intended to ~~fraud~~ensure the safety and ~~abuse~~effectiveness of the device including, among other things, restrictions on labeling, promotion, sale and distribution and conduct of additional post-approval clinical studies or collection of long-term follow-up from patients’ ~~rights~~in ~~may~~the beclinical ~~applicable~~study tothat ~~our~~supported ~~business~~approval. WeFailure ~~may~~to becomply ~~subject~~with tothe ~~healthcare~~conditions ~~fraud~~of ~~and~~approval ~~abuse~~can ~~and~~result ~~patient~~in materially adverse enforcement action, including the loss or withdrawal of the approval.

10If a manufacturer plans to make significant modifications to the manufacturing process, labeling, or design of an approved PMA device, the manufacturer must submit an application called a “PMA Supplement” regarding the change. The FDA generally reviews PMA Supplements on a 180-day agency timetable, which may be extended if significant questions arise in review of the supplement. A manufacturer may implement limited changes prior to the FDA’s review of a PMA Supplement. The FDA designates some PMA Supplements as “panel-track” supplements, which means that the agency believes review by an advisory panel may be warranted. Designation as a panel-track supplement does not necessarily mean that panel review will occur.

~~privacy~~Clinical ~~regulation~~or byMarket Trials. A clinical trial is typically required to support a PMA application and is sometimes required for a 510(k) premarket notification. Clinical trials conducted to support premarket clearance or approval generally require submission of an application for an Investigational Device Exemption (IDE) to the ~~federal~~FDA. ~~government,~~Appropriate data must support the ~~states~~IDE application, such as animal and ~~the~~laboratory ~~international~~testing ~~jurisdictions~~results, inshowing ~~which~~that weit ~~conduct~~is ~~our~~safe ~~business.~~to ~~The~~test ~~regulations~~the device in humans and that ~~may~~the ~~affect~~investigational ~~our~~protocol ~~ability~~is toscientifically ~~operate~~sound. ~~include,~~The ~~without~~IDE ~~limitation:~~application must be approved

the federal Anti-Kickback Statute, which prohibits, among other things, any person from knowingly and willfully offering, soliciting, receiving, or providing remuneration, directly or indirectly, to induce either the referral of an individual, for an item or service or the purchasing or ordering of a good or service, for which payment may be made under federal healthcare programs such as the Medicare and Medicaid programs;10

by the ~~federal~~FDA ~~False~~for ~~Claims~~a ~~Act,~~specified ~~which~~number ~~prohibits~~of patients, ~~among~~unless ~~other~~the ~~things,~~product ~~individuals,~~is ordeemed ~~entities~~eligible ~~from~~for ~~knowingly~~more ~~presenting~~abbreviated IDE requirements. Clinical trials for a significant risk device may begin once the FDA approves the IDE application. All FDA-regulated clinical studies, whether significant or ~~causing~~non-significant torisk, must be ~~presented~~approved and overseen by the appropriate institutional review boards (IRBs) for each clinical trial, ~~false~~and ~~claims~~informed consent of the patients participating in the clinical trial must be obtained. After a trial begins, the FDA may place it on hold or ~~knowingly~~terminate ~~using~~it, ~~false~~if, ~~statements~~among other reasons, it concludes that the clinical subjects are exposed to ~~obtain~~an ~~payment~~unacceptable ~~from~~health risk. Any trials we conduct in the United States must be conducted in accordance with FDA regulations as well as other federal ~~government,~~regulations and ~~which~~state ~~may~~laws ~~apply~~concerning tohuman ~~entities~~subject ~~that~~protection ~~provide~~and ~~coding~~privacy. ~~and~~Moreover, ~~billing~~the ~~advice~~results of a clinical trial may not be sufficient to ~~customers;~~obtain clearance or approval of the product.

~~federal~~Oversight ~~criminal~~of ~~laws~~compliance ~~that~~with ~~prohibit~~quality, ~~executing~~medical device reporting, clinical study, and other regulations. Both before and after we receive premarket clearance or approval and release a ~~scheme~~product commercially, we have ongoing responsibilities under FDA regulations. The FDA reviews design and manufacturing practices, labeling and record keeping, product complaints and manufacturer’s required reports of adverse experiences, product corrections and removals, and other information to ~~defraud~~identify ~~any~~potential ~~healthcare~~problems ~~benefit~~with ~~program~~marketed ormedical ~~making~~devices. ~~false~~We ~~statements~~are ~~relating~~also subject to ~~healthcare~~periodic ~~matters;~~inspection by the FDA for compliance with the FDA’s QSR and other requirements, such as requirements for advertising and promotion. The Good Manufacturing Practice (GMP) regulations for medical devices embodied in the QSR govern the methods used in, and the facilities and controls used for, the design, manufacture, packaging, labeling, and servicing of all finished medical devices intended for human use. The FDA has issued a final rule to implement the Quality Management System Regulation (QMSR), which is intended to harmonize U.S. quality system requirements more closely with ISO 13485, and the transition to QMSR could require updates to our quality system documentation and processes.

~~the~~The ~~federal~~FDA’s ~~physician~~Bioresearch ~~sunshine~~Monitoring ~~requirements~~Program ~~under~~(BIMO), ~~the~~reviews ~~Patient~~our ~~Protection~~activities ~~and~~as ~~Affordable~~a ~~Care~~sponsor ~~Act~~ of ~~2010,~~clinical ~~which~~research. ~~requires~~BIMO ~~manufacturers~~conducts offacilities ~~drugs,~~inspections ~~devices,~~as ~~biologics,~~part ~~and~~of ~~medical~~a ~~supplies~~program todesigned ~~report annually~~ to ~~the~~ensure ~~Centers~~that ~~for~~data ~~Medicare~~and ~~& Medicaid Services~~ information ~~related~~contained toin ~~payments~~requests ~~and~~for ~~other~~IDEs, ~~transfers~~PMA ofapplications ~~value~~and ~~relating~~510(k) tosubmissions ~~certain~~are ~~drugs,~~scientifically ~~devices~~valid, ~~biologics~~reliable, and ~~medical~~accurate. ~~supplies~~Another toobjective ~~physicians,~~of ~~other~~the ~~healthcare~~program ~~providers,~~is ~~and~~to ~~teaching~~ensure ~~hospitals,~~that ~~and~~human ~~ownership~~subjects ~~and~~are ~~investment~~protected ~~interests~~from ~~held~~undue byhazard ~~physicians~~or ~~and~~risk ~~other~~during ~~healthcare~~scientific ~~providers and their immediate family members;~~investigations.

If the ~~federal~~FDA ~~Health~~were ~~Insurance~~to ~~Portability~~conclude that we are not in compliance with applicable laws or regulations, or that any of our medical devices are ineffective or pose an unreasonable health risk, the FDA could require us to notify health professionals and ~~Accountability~~others ~~Act~~that the devices present unreasonable risk or substantial harm to public health, order a recall, repair, replacement, or refund of ~~1996~~the devices, asdetain, ~~amended~~or byseize adulterated or misbranded medical devices, or ban the ~~Health~~medical ~~Information~~devices. ~~Technology~~The FDA may also issue warning letters or untitled letters, refuse our request for ~~Economic~~510(k) clearance or PMA approval, revoke existing 510(k) clearances or PMA approvals previously granted, impose operating restrictions, enjoin, and ~~Clinical~~restrain ~~Health~~certain ~~Act~~violations of ~~2009~~applicable law pertaining to medical devices and assess civil or criminal penalties against our officers, ~~which~~employees, ~~governs~~or us. The FDA may also recommend prosecution to the ~~conduct~~Department of ~~certain~~Justice. ~~electronic~~In ~~healthcare~~the ~~transactions~~case ~~and~~of ~~protects~~devices subject to pending premarket clearance or approval applications, FDA has broad authority to halt the ~~security~~review of applications and ~~privacy~~require ofsignificant ~~protected~~additional ~~health~~data ~~information;~~analyses, audits, and other corrective actions where clinical data contained in an application are deemed to be actually or potentially unreliable, inaccurate, or not in compliance with clinical study or good clinical practice requirements.

~~state~~Healthcare ~~and~~Fraud ~~international law equivalents of each of the above federal laws, such as anti-kickback~~ and ~~false~~Abuse ~~claims~~Laws laws which may apply to items or services reimbursed by any third-party payer, including commercial insurers; state laws that require device companies to comply with the industry’s voluntary compliance guidelines and ~~the~~Regulations applicable compliance guidance promulgated by the federal government, or otherwise restrict payments that may be made to healthcare providers and other potential referral sources; state and international laws that require device manufacturers to report information related to payments and other transfers of value to physicians and other healthcare providers or marketing expenditures; and state and international laws governing the privacy and security of health information in ~~certain circumstances, which may differ from each other and may not have~~ the ~~same~~United ~~effect, thus complicating compliance efforts~~States.

~~Because~~Even ofthough ~~the~~we ~~breadth~~do ofnot ~~these~~control ~~laws~~referrals ~~and the narrowness~~ of ~~the~~healthcare ~~statutory~~services ~~exceptions~~or ~~and~~bill ~~safe~~directly ~~harbors~~to ~~available~~Medicare, itMedicaid ~~is possible that some of our business activities could be subject to challenge under one~~ or ~~more~~other ofthird-party ~~such~~payers, ~~laws.~~certain ~~In addition~~federal, ~~recent~~state ~~health~~and ~~care~~international ~~reform~~healthcare ~~legislation has strengthened these~~ laws. ~~For~~and ~~example,~~regulations ~~the~~pertaining ~~Health~~to ~~Care~~fraud ~~Reform~~and ~~Law,~~abuse ~~among~~and ~~other~~patients’ ~~things,~~rights ~~amends~~may ~~the~~be ~~intent~~applicable ~~requirement~~to ofour ~~the~~business. ~~Federal~~We ~~Anti-Kickback~~may ~~Statute~~be ~~and~~subject ~~criminal~~to healthcare fraud ~~statutes.~~and Aabuse ~~person~~and orpatient ~~entity~~privacy noregulation ~~longer~~by ~~needs to have actual knowledge of~~ the ~~statute~~federal ~~or specific intent to violate it. In addition~~government, the ~~Patient~~states ~~Protection~~ and ~~Affordable Care Act provides that~~ the ~~government~~international ~~may~~jurisdictions ~~assert~~in ~~that~~which awe ~~claim~~conduct ~~including~~our ~~items~~business. orThe ~~services~~regulations ~~resulting~~that ~~from~~may aaffect ~~violation~~our ofability ~~the~~to ~~Federal~~operate ~~Anti-Kickback~~include, ~~Statute~~without ~~constitutes a false or fraudulent claim for purposes of the False Claims Act.~~limitation:

•

~~Medical~~the ~~Device~~federal ~~Regulations~~Anti-Kickback ~~Outside~~Statute, which prohibits, among other things, any person from knowingly and willfully offering, soliciting, receiving, or providing remuneration, directly or indirectly, to induce either the ~~United~~referral ~~States.~~of an individual, for an item or service or the purchasing or ordering of a good or service, for which payment may be made under federal healthcare programs such as the Medicare and Medicaid programs;

•

~~CE Marking. In~~ the ~~European~~federal ~~Economic~~False ~~Area~~Claims ~~(EEA)~~Act, which isprohibits, ~~comprised~~among ofother ~~the 27 Member States of the European Union plus Norway~~things, ~~Iceland~~individuals, ~~and~~or ~~Liechtenstein,~~entities ~~legacy~~from ~~medical~~knowingly ~~devices~~presenting, ~~must~~or ~~comply~~causing ~~with the essential requirements of the EU Medical Devices Directive (Council Directive 93/42/EEC). Compliance with the essential requirements of the EU Medical Device Directive is a prerequisite~~ to be ~~able~~presented, tofalse ~~affix a Conformité Européenne Mark (CE Mark)~~claims, ~~without which medical devices cannot be marketed~~ or ~~sold~~knowingly inusing ~~the~~false ~~EEA.~~statements, Toto ~~demonstrate~~obtain ~~compliance~~payment ~~with~~from the ~~essential~~federal ~~requirements~~government, ~~medical~~and ~~device manufacturers must undergo a conformity assessment procedure,~~ which ~~varies~~may ~~according~~apply to ~~the~~entities ~~type~~that ofprovide ~~medical~~coding ~~device~~ and ~~its~~billing ~~classification.~~advice to customers;

The method of assessing conformity varies depending on the class of the product, but normally involves a combination of self-assessment by the manufacturer and a third-party assessment by a “Notified Body.” Notified Bodies are a group of private quality-monitoring organizations that are accredited to review medical devices and to monitor quality systems and adverse event reporting. The independent Notified Bodies perform, on a privatized basis, functions similar to the FDA in the U.S. and the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan. 11

•

11federal criminal laws that prohibit executing a scheme to defraud any healthcare benefit program or making false statements relating to healthcare matters;

•

~~Our~~the ~~facilities~~federal inphysician sunshine requirements under the ~~United~~Patient ~~States~~Protection and ~~Switzerland~~Affordable ~~are~~Care ~~subject~~Act toof ~~regular~~2010, ~~inspection~~which byrequires amanufacturers ~~designated~~of ~~Notified~~drugs, ~~Body.~~devices, ~~Other countries~~biologics, ~~such~~and asmedical ~~Switzerland~~supplies ~~and~~to report annually to the ~~United~~Centers ~~Kingdom,~~for ~~have~~Medicare ~~voluntarily~~& ~~adopted~~Medicaid ~~laws~~Services ~~and~~information ~~regulations~~related ~~that~~to ~~largely~~payments ~~mirror~~and ~~those~~other transfers of ~~the~~value ~~European~~relating ~~Union~~to ~~with~~certain ~~respect~~drugs, todevices, biologics, and medical ~~devices~~supplies to physicians, other healthcare providers, and ateaching ~~number~~hospitals, ofand ~~countries~~ownership ~~outside~~and ofinvestment ~~Europe~~interests ~~permit~~held ~~importation~~by ofphysicians ~~devices~~and ~~bearing~~other ~~the~~healthcare CEproviders ~~Mark.~~and their immediate family members;

•

~~The European Union regulatory bodies finalized a new Medical Device Regulation (MDR) in 2017, which replaced~~ the ~~existing~~federal ~~Directives~~Health ~~and~~Insurance ~~provided~~Portability ~~three years for transition~~ and ~~compliance.~~Accountability ~~The~~Act ~~MDR will change several aspects~~ of ~~the existing regulatory framework~~1996, ~~such~~ as ~~updating~~amended clinical data requirements and introducing new ones, such as Unique Device Identification (UDI). We and the Notified Bodies who will oversee compliance to the new MDR face uncertainties and increased costs as the MDR is rolled out and enforced by the ~~European~~Health ~~Commission~~Information ~~and~~Technology EEA Competent Authorities, creating risks in several areas, including the CE Marking process and data transparency, in the upcoming years. In March 2023, the European Union extended the EU MDR transition periods for ~~devices~~Economic ~~transitioning to the EU MDR from May 2024 to May 2026 for class III implantable custom-made devices,~~ and ~~December~~Clinical ~~31,~~Health ~~2027~~Act ~~for class III and implantable class IIb devices. The exit~~ of ~~the UK from the European Union (BREXIT) in 2020 resulted in the requirement to re-certify our preloaded acrylic cataract IOL under a non-UK Notified Body~~2009, ~~and~~which togoverns ~~separately register our CE Marked products for sale in~~ the ~~UK.~~conduct ~~In 2023, the UK extended to June 2028 the allowance~~ of ~~medical~~certain ~~devices~~electronic ~~with~~healthcare atransactions ~~valid declaration~~ and CEprotects ~~marking to be placed on~~ the ~~Great~~security ~~Britain market. The failure of Switzerland~~ and ~~the~~privacy ~~EU to enter into a Mutual Recognition Agreement resulted in a change~~ of ~~our~~protected EChealth ~~Authorized~~information; ~~Representative, discontinuance of the pre-loaded acrylic cataract IOL for the Swiss market,~~ and registration of our remaining products under Swiss law. We have since stopped manufacturing our preloaded acrylic cataract IOL and have phased out sales of our cataract IOLs as we focus on growing our ICL business.

•

Westate ~~have~~and ~~affixed~~international law equivalents of each of the CEabove ~~Mark~~federal tolaws, ~~all~~such ~~our~~as ~~principal~~anti-kickback ~~products~~and ~~sold~~false inclaims CElaws ~~Mark~~which ~~jurisdictions~~may ~~including~~apply ~~ICLs~~to ~~and~~items ~~delivery~~or ~~systems.~~services Inreimbursed ~~July~~by ~~2022~~any third-party payer, ~~our~~including ~~Notified~~commercial ~~Body~~insurers; instate ~~the~~laws ~~European~~that ~~Union,~~require ~~DEKRA,~~device ~~certified~~companies ~~the~~to CEcomply ~~Marking~~with ~~for~~the ~~our~~industry’s ~~currently~~voluntary ~~certified~~compliance guidelines and ~~commercially~~the ~~available~~applicable ~~ICLs,~~compliance ~~delivery~~guidance ~~systems~~promulgated by the federal government, ~~and~~or ~~calculation~~otherwise ~~software~~restrict ~~under~~payments ~~the~~that ~~new~~may ~~MDR.~~be ~~During~~made ~~the~~to ~~fourth~~healthcare ~~quarter~~providers ofand ~~2021~~other potential referral sources; state and ~~the~~international ~~first~~laws ~~quarter~~that ofrequire ~~2022,~~device ~~DEKRA~~manufacturers ~~performed~~to ~~audits~~report ofinformation ~~our~~related USto payments and ~~Swiss~~other ~~facilities~~transfers ~~certifying~~of ~~them~~value to ~~the~~physicians ~~MDR~~and ~~requirements,~~other ENhealthcare ~~ISO~~providers ~~13485:2016~~or asmarketing ~~well~~expenditures; asand tostate ~~the~~and ~~“Medical~~international ~~Device~~laws ~~Single~~governing ~~Audit~~the ~~Program”~~privacy ~~(MDSAP).~~and ~~MDSAP~~security ~~provides~~of ~~for~~health ainformation ~~single~~in ~~audit~~certain ~~recognized~~circumstances, bywhich ~~Australia,~~may ~~Brazil,~~differ ~~Canada,~~from ~~Japan~~each other and ~~the~~may ~~United~~not ~~States~~have ~~demonstrating~~the ~~routine~~same ~~compliance~~effect, ~~with~~thus ~~QSR/GMP~~complicating ~~requirements~~compliance efforts.

~~Medical~~Because ~~Device~~of ~~Regulation~~the inbreadth ~~Japan. The Japanese Ministry~~ of ~~Health,~~these ~~Labor,~~laws and ~~Welfare~~the ~~(MHLW)~~narrowness ~~regulates~~of the ~~sale~~statutory ofexceptions ~~medical~~and ~~devices~~safe ~~under~~harbors ~~Japan’s~~available, ~~Pharmaceuticals~~it ~~and~~is ~~Medical~~possible ~~Devices~~that ~~Act~~some ~~(PMD~~of ~~Act).~~our ~~The~~business ~~Pharmaceuticals~~activities ~~and~~could ~~Medical~~be ~~Devices~~subject ~~Agency~~to ~~(PMDA),~~challenge aunder ~~quasi-governmental~~one ~~organization,~~or ~~performs~~more ~~many~~ of ~~the~~such ~~medical~~laws. ~~device~~In ~~review~~addition, ~~functions~~recent ~~for~~health ~~MHLW.~~care ~~Medical~~reform ~~devices~~legislation ~~generally~~has ~~must~~strengthened ~~undergo~~these ~~thorough~~laws. ~~safety~~For ~~examinations~~example, ~~and~~the ~~demonstrate~~Health ~~medical~~Care ~~effectiveness~~Reform ~~before~~Law, ~~the~~among ~~MHLW~~other ~~grants~~things, ~~shonin~~amends ~~(premarket~~the ~~device~~intent ~~approval)~~requirement orof ~~ninsho~~the ~~(premarket~~Federal ~~certification).~~Anti-Kickback ~~Manufacturers~~Statute and ~~resellers~~criminal ~~(referred~~healthcare tofraud asstatutes. ~~Marketing~~A ~~Authorization~~person ~~Holders~~ or ~~MAHs)~~entity ~~must~~no ~~also~~longer ~~satisfy~~needs ~~certain~~to ~~requirements~~have ~~before~~actual ~~the~~knowledge ~~MHLW~~of ~~grants~~the astatute ~~business license,~~ or ~~kyoka.~~specific ~~Requirements~~intent ~~for~~to ~~manufacturers~~violate ~~and~~it. ~~MAHs~~In ~~include~~addition, ~~compliance~~the ~~with~~Patient ~~Japanese~~Protection ~~regulations covering GQP (good quality practice)~~ and ~~GVP~~Affordable ~~(good~~Care ~~vigilance~~Act ~~practice),~~provides ~~which~~that ~~largely include conformity to~~ the ~~ISO~~government ~~13485~~may ~~standard~~assert ~~and~~that ~~are~~a ~~similar~~claim toincluding ~~good~~items ~~manufacturing~~or ~~practice~~services ~~and~~resulting ~~post-market~~from ~~surveillance~~a ~~requirements~~violation inof the ~~United~~Federal ~~States,~~Anti-Kickback asStatute ~~well~~constitutes asa ~~the~~false ~~assignment~~or offraudulent ~~internal~~claim ~~supervisors~~for ~~over~~purposes ~~marketing,~~of ~~quality~~the ~~assurance,~~False ~~and~~Claims ~~safety control~~Act.

~~Approval~~Medical ~~for~~Device aRegulations ~~new~~Outside ~~medical device that lacks a substantial equivalent in~~ the ~~Japanese~~United ~~market will generally require the submission of clinical trial data~~States. Only a licensed MAH can apply for premarket device approval in Japan, and in most cases, the clinical trial data must include data gathered from Japanese subjects. For example, STAAR Japan conducted a separate clinical trial in Japan for the shonin application for the ICL. Also, approval for a new medical device will require the manufacturer to undertake to reexamine the safety and effectiveness of the device with a review of post-market data gathered within a certain period - normally four years - after approval. The specific post-market reexamination requirement for a medical device is announced at the time of approval.

~~STAAR~~CE ~~Japan~~Marking. ~~currently~~In ~~holds shonin approval for~~ the ~~ICL~~European ~~products,~~Economic ~~preloaded~~Area ~~injectors~~(EEA), ~~and~~which ~~their~~is ~~associated~~comprised ~~lenses, and kyoka licensing as a manufacturer and MAH~~ of ~~medical~~the ~~devices.~~27 ~~The~~Member ~~sponsor~~States of ~~a clinical trial submitted to~~ the ~~PMDA~~European ~~must~~Union ~~strictly~~plus ~~follow~~Norway, ~~Good~~Iceland, ~~Clinical~~and ~~Practice~~Liechtenstein, ~~(GCP)~~legacy ~~standards~~medical ~~and~~devices must ~~follow~~comply ~~the trial~~ with ~~standard~~the ~~Good~~essential ~~Post-Market~~requirements ~~Study~~of ~~Practice (GPSP) reporting and a follow-up program. MHLW and PMDA also assess~~ the ~~quality~~EU ~~management~~Medical ~~systems~~Devices ofDirective ~~manufacturers~~(Council ~~and~~Directive ~~the~~93/42/EEC). ~~conformity~~Compliance ofwith ~~products to~~ the essential requirements of the ~~PMD~~EU ~~Act.~~Medical ~~STAAR~~Device Directive is ~~subject~~a prerequisite to ~~inspection~~be ~~for~~able ~~compliance by these agencies. A company’s failure~~ to ~~comply~~affix ~~with~~a ~~the~~Conformité ~~PMD~~Européenne ~~Act~~Mark ~~can~~(CE ~~result in severe penalties~~Mark), ~~including~~without ~~revocation~~which ormedical ~~suspension~~devices ofcannot abe ~~company’s~~marketed ~~business~~or ~~license~~sold ~~and~~in ~~possible~~the ~~criminal sanctions~~EEA. IfTo ~~the~~demonstrate ~~PMDA were to conclude that we are not in~~ compliance with ~~applicable~~the ~~laws~~essential ~~or regulations~~requirements, ~~or that any of our~~ medical ~~devices~~device ~~are~~manufacturers ~~ineffective~~must orundergo ~~pose~~a anconformity ~~unreasonable~~assessment ~~health risk~~procedure, ~~they~~which ~~could~~varies ~~take~~according ~~a variety of regulatory or legal actions, similar~~ to the ~~U.S.~~type ~~FDA,~~of ~~which~~medical ~~could~~device ~~have a material~~ and ~~negative~~its ~~impact on the Company~~classification.

12The method of assessing conformity varies depending on the class of the product, but normally involves a combination of self-assessment by the manufacturer and a third-party assessment by a “Notified Body.” Notified Bodies are a group of private conformity assessment organizations that are accredited to review medical devices and to audit quality systems and assess manufacturers’ post-market surveillance and vigilance processes. The independent Notified Bodies perform, on a privatized basis, functions that assess adherence to regulations, which is similar to the FDA in the U.S. and the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan. Our facilities in the United States and Switzerland are subject to regular inspection by a designated Notified Body. Other countries, such as Switzerland and the United Kingdom, have voluntarily adopted laws and regulations that largely mirror those of the European Union with respect to medical devices, and a number of countries outside of Europe permit importation of devices bearing the CE Mark.

The European Union finalized a new Medical Device Regulation (MDR) in ~~China~~2017, which replaced the existing Directives and ~~Korea~~established a transition period for devices previously certified under the Directives. ~~Sales~~The MDR will change several aspects of ~~our~~the ~~products~~existing inregulatory ~~China~~framework, such as updating clinical data requirements and ~~Korea~~introducing new ones, such as Unique Device Identification (UDI). We and the Notified Bodies who will oversee compliance to the new MDR face uncertainties and increased costs as the MDR is rolled out and enforced by the European Commission and EEA Competent Authorities, creating risks in ~~other~~several ~~countries~~areas, ~~are~~including ~~also~~the ~~subject~~CE toMarking ~~regulatory~~process ~~requirements~~and data transparency, in the upcoming years. In March 2023, the European Union extended the EU MDR

In China, medical devices such as our ICLs are mainly regulated by Regulations on the Supervision and Administration of Medical Device (Decree No. 739) promulgated by the State Council. National Medical Products Administration (NMPA) is the governmental authority principally responsible for the supervision and administration of medical devices in China. 12

~~Each~~transition ~~medical~~periods ~~device~~for ~~intended~~devices ~~for~~transitioning ~~commercial~~to ~~distribution~~the inEU ~~China~~MDR isfrom ~~subject~~May 2024 to aMay ~~mandatory~~2026 ~~filing~~for orclass ~~registration~~III ~~regime~~custom-made ~~regulated~~implantable bydevices, and December 31, 2027 for class III and implantable class IIb devices. Class IIb (non-implantable), Class IIa and Class I devices requiring Notified Body involvement may continue to be placed on the ~~NMPA~~market until December 31, 2028, provided specified conditions are met. The ~~classification~~exit of ~~such~~the ~~devices~~UK ~~mainly~~from ~~determines~~the European Union (BREXIT) in 2020 resulted in the ~~filing~~requirement ~~pathways.~~to ~~China~~re-certify ~~has~~our preloaded acrylic cataract IOL under a ~~three~~non-~~class~~UK ~~classification~~Notified ~~system~~Body, ~~from~~and ~~Class~~to Iseparately ~~(lowest~~register ~~risk)~~our toCE ~~Class~~Marked ~~III~~products ~~(highest~~for ~~risk)~~sale in the UK. ~~Most~~In of2023, ~~STAAR’s~~the ~~medical~~UK ~~devices~~extended ~~are~~to ~~Class~~June II2028 ~~and~~the ~~Class~~allowance ~~III~~of medical devices with a valid declaration and ~~are~~CE ~~subject~~marking to abe ~~restricted~~placed ~~registration~~on ~~pathway.~~the ~~Applicants~~Great ~~are~~Britain ~~required~~market (subject to ~~submit~~the aterms ~~product~~of ~~technical~~the ~~requirements~~UK ~~(PTR)~~transitional ~~document~~regime and, ~~which~~in ~~shall~~general, ~~mainly~~until ~~include~~the earlier of the ~~performance~~applicable ~~indicators~~deadline ~~and~~or ~~testing~~the ~~methods~~expiration of the ~~medical~~CE ~~device~~certificate). ~~Also,~~The ~~applicants~~failure ~~must~~of ~~have~~Switzerland ~~samples~~and of the ~~device~~EU ~~tested~~to inenter into a ~~government-recognized~~Mutual ~~lab~~Recognition orAgreement ~~submit~~resulted in~~-house~~ ora ~~qualified~~change ~~third-party~~of ~~testing~~our ~~results.~~European ~~The~~Union ~~PTR~~Authorized Representative, ~~test~~the ~~reports,~~appointment ~~quality~~of ~~system~~a ~~documents,~~Swiss ~~labeling~~Authorized ~~information~~Representative, ~~together~~discontinuance ~~with~~of ~~other~~the ~~registration~~pre-loaded ~~documents,~~acrylic ~~are~~cataract ~~submitted~~IOL tofor the ~~Center~~Swiss ~~for~~market, ~~Medical~~and ~~Device~~registration ~~Evaluation~~of ~~(CMDE)~~our ~~division~~remaining products under Swiss law. We have since stopped manufacturing our preloaded acrylic cataract IOL and have phased out sales of ~~the~~our ~~NMPA~~cataract ~~for~~IOLs ~~technical~~as ~~evaluation.~~we focus on growing our ICL business.

IfWe ~~approved~~have affixed the CE Mark to all our principal products sold in CE Mark jurisdictions including ICLs and delivery systems. In July 2022, ~~NMPA~~our ~~issues~~Notified Body in the ~~medical~~European ~~device~~Union, aDEKRA, ~~registration~~certified ~~license~~the ~~valid~~CE Marking for ~~five~~our ~~years~~currently certified and commercially available ICLs, delivery systems, and calculation software under the new MDR. ~~The~~During ~~manufacturer~~the ~~submits~~fourth aquarter ~~renewal~~of ~~application~~2021 ~~before~~and the ~~license~~first ~~expiration~~quarter ~~date~~of 2022, DEKRA performed audits of our US and Swiss facilities certifying them to ~~renew~~the aMDR ~~medical~~requirements, ~~device’s~~EN ~~registration~~ISO 13485:2016 as well as to the “Medical Device Single Audit Program” (MDSAP). MDSAP provides for a single audit recognized by Australia, Brazil, Canada, Japan and the United States demonstrating routine compliance with quality management system requirements.

~~After~~Medical ~~approval,~~Device Regulation in ~~case~~Japan. The Japanese Ministry of ~~substantial~~Health, ~~changes~~Labor, toand Welfare (MHLW) regulates the ~~design,~~sale ~~raw~~of ~~materials,~~medical ~~manufacturing~~devices ~~process,~~under Japan’s Pharmaceuticals and ~~indications~~Medical Devices Act (PMD Act). The Pharmaceuticals and Medical Devices Agency (PMDA), ~~among~~a ~~other~~quasi-governmental ~~things~~organization, ~~that~~performs ~~may~~many ~~affect~~of the medical device's review functions for MHLW. Medical devices generally must undergo thorough safety examinations and demonstrate medical effectiveness, before the ~~manufacturer~~MHLW ~~applies~~grants toshonin ~~NMPA~~(premarket ~~for~~device approval) ofor ~~such~~ninsho ~~registration~~(premarket ~~changes~~certification). InManufacturers ~~case~~and ofresellers ~~minor~~(referred ~~changes~~to ~~that~~as doMarketing ~~not~~Authorization ~~affect~~Holders or MAHs) must also satisfy certain requirements before the ~~medical~~MHLW ~~device's~~grants ~~safety~~a business license, or kyoka. Requirements for manufacturers and ~~effectiveness~~MAHs include compliance with Japanese regulations covering GQP (good quality practice) and GVP (good vigilance practice), which largely include conformity to the ~~manufacturer~~ISO ~~submits~~13485 astandard ~~change~~and ~~notification~~are similar to ~~NMPA.~~quality management system and post-market surveillance requirements in the United States, as well as the assignment of internal supervisors over marketing, quality assurance, and safety control.

~~While~~Approval ~~STAAR~~for ~~Surgical~~a AGnew ~~and~~medical ~~STAAR~~device ~~Surgical~~that ~~Company~~lacks ~~hold~~a substantial equivalent in the ~~licenses,~~Japanese ~~STAAR~~market ~~China~~will ~~serves~~generally asrequire athe ~~local~~submission ~~agent.~~of ~~The~~clinical ~~local~~trial ~~agent~~data. isOnly ~~authorized~~a tolicensed ~~submit~~MAH ~~the~~can ~~registration~~apply ~~application~~for ~~materials~~premarket todevice ~~NMPA~~approval in Japan, and ~~provides~~in ~~maintenance~~most ~~support~~cases, ~~and~~the ~~technical~~clinical ~~service,~~trial ~~oversees~~data ~~the~~must ~~registration~~include ~~and~~data ~~clinical~~gathered ~~trial~~from ~~process~~Japanese subjects. ~~Under~~For ~~Decree 1~~example, ~~Medical~~STAAR ~~Device~~Japan ~~Adverse~~conducted ~~Event~~a ~~Reporting~~separate ~~and~~clinical ~~Reevaluation,~~trial in Japan for the ~~license~~shonin ~~holder~~application ~~bears~~for the ~~primary~~ICL. ~~responsibility~~Also, approval for ~~monitoring~~a new medical device ~~adverse~~will ~~events~~require ~~(AEs)~~the manufacturer to undertake to reexamine the safety and ~~establishing~~effectiveness anof AEthe ~~monitoring~~device ~~system~~with a review of post-market data gathered within a certain period - normally four years - after approval. The ~~local~~specific ~~agent~~post-market ~~helps~~reexamination ~~manage~~requirement ~~AEs~~for ina ~~case~~medical of device ~~malfunction~~is announced at the time of approval.

STAAR Japan currently holds shonin approval for the ICL products, preloaded injectors, and their associated lenses, and kyoka licensing as a manufacturer and MAH of medical devices. The ~~license~~sponsor ~~holder~~of a clinical trial submitted to the PMDA must strictly follow Good Clinical Practice (GCP) standards and ~~local~~must ~~agent~~follow ~~are~~the ~~responsible~~trial ~~for~~with ~~carrying~~standard ~~out~~Good ~~self~~Post-~~inspection~~Market ofStudy Practice (GPSP) reporting and a follow-up program. MHLW and PMDA also assess the quality management ~~system~~systems ~~periodically~~of manufacturers and the conformity of products to the requirements of the PMD Act. ~~They~~STAAR ~~are~~is ~~also~~subject ~~responsible~~to inspection for ~~identifying,~~compliance ~~monitoring~~by these agencies. A company’s failure to comply with the PMD Act can result in severe penalties, including revocation or suspension of a company’s business license and ~~trending~~possible ~~adverse~~criminal ~~events~~sanctions. ~~related~~If the PMDA were to ~~the~~conclude that we are not in compliance with applicable laws or regulations, or that any of our medical ~~device~~devices are ineffective or pose an unreasonable health risk, they could take a variety of regulatory or legal actions, similar to the U.S. FDA, which could have a material and negative impact on the Company.

~~In Korea, a registration of medical devices such as our ICLs is overseen by the Ministry of Food and Drug Safety (MFDS) pursuant to the~~ Medical Device ~~Act.~~Regulation ~~The~~in ~~Medical~~China ~~Device Safety Bureau of the MFDS holds primary responsibility for medical device regulations, while departments within the National Institute of Food~~ and ~~Drug Safety Evaluation (NIFDS) oversee the evaluation and research of medical devices. Medical devices require registration and/or approval prior to commercialization. In~~ Korea, medical device classification closely follows the Global Harmonization Task Force (GHTF) Classification guidelines, with Class I, II, III and IV designations being ranked from low- to high-risk categorization. ~~The~~Sales ~~registration review route depends on the risk classification~~ of ~~the device. Typically, the MFDS requires similar documentation as required to obtain a CE Mark. Our distributor in Korea is contractually required to obtain, with~~ our ~~assistance, the necessary health registrations, governmental approvals, or clearances to import, market and sell our~~ products. Inin ~~Korea,~~China ~~we provide our distributor with information~~ and data to obtain appropriate registrations and approvals, and the distributor obtains such registrations. In addition to the device registration, MFDS requires all devices Class II and above to comply with Korean Good Manufacturing Practice (KGMP) quality system standards in order to be marketed in Korea~~. KGMP standards are based on ISO 13485 quality system standards. However~~, ~~they~~as ~~are not identical. Therefore, ISO 13485 certificates issued by a notified body~~ in ~~the EU will not be sufficient. To obtain KGMP certification, documents that pertain to all areas of compliance, including design, risk assessment, technical requirements and any~~ other ~~quality system requirements~~countries, ~~need~~are toalso besubject ~~submitted~~ to anregulatory ~~MFDS-authorized third party~~requirements. Our distributor in Korea submits the application on behalf of STAAR. After the application is submitted, the manufacturing site undergoes either a paper audit or an onsite inspection/audit by an authorized third party and MFDS. Medical device registration licenses do not expire, but the KGMP certificate must be renewed every three years.

IfIn ~~the~~China, ~~NMPA~~medical ordevices ~~MFDS~~such ~~were~~as toour ~~conclude~~ICLs ~~that we~~ are ~~not~~mainly inregulated ~~compliance~~by ~~with~~Regulations ~~applicable~~for ~~laws~~the orSupervision ~~regulations,~~and orAdministration ~~that any~~ of ~~our~~Medical ~~medical~~Device ~~devices~~(Decree ~~are~~No. ~~ineffective~~739) orpromulgated ~~pose~~by anthe ~~unreasonable~~State ~~health~~Council. ~~risk,~~National ~~they~~Medical ~~could~~Products ~~take a variety of~~

~~regulatory~~Administration or(NMPA) ~~legal~~is ~~actions~~the ingovernmental ~~their~~authority ~~respective~~principally ~~countries,~~responsible ~~similar~~for to the ~~U.S.~~supervision ~~FDA, which could have a material~~ and ~~negative~~administration ~~impact~~of onmedical ~~the~~devices ~~Company.~~in China.

~~Third~~Each medical device intended for commercial distribution in China is subject to a mandatory filing or registration regime regulated by the NMPA. The classification of such devices mainly determines the filing pathways. China has a three-~~Party~~class ~~Coverage~~classification system, from Class I (lowest risk) to Class III (highest risk). Most of STAAR’s medical devices are Class II and ~~Reimbursement~~Class III devices and are subject to a restricted registration pathway. Applicants are required to submit a Product Technical Requirements (PTR) document, which shall mainly include the performance indicators and testing methods of the medical device. Also, applicants must have samples of the device tested in a government-recognized lab or submit in-house or qualified third-party testing results. The PTR, test reports, quality system documents, labeling information, together with other registration documents, are submitted to the Center for Medical Device Evaluation (CMDE) division of the NMPA for technical evaluation.

~~Health~~If ~~care providers generally rely on third-party payers~~approved, ~~including~~NMPA ~~governmental~~issues ~~payers such as Medicare and Medicaid, private insurance plans and workers’ compensation plans, to cover and reimburse~~ the ~~cost of~~ medical ~~devices~~device ~~and~~a ~~related~~registration ~~services.~~license ~~These~~valid ~~third-party~~for ~~payers~~five ~~may~~years. ~~deny~~The ~~coverage~~manufacturer orsubmits ~~reimbursement for~~ a ~~medical~~renewal ~~device~~application ifbefore ~~they determine that~~ the ~~product~~license orexpiration ~~procedure~~date ~~using~~to ~~the~~renew ~~product~~a ~~was not medically appropriate or necessary, and they are increasingly challenging the price of~~ medical ~~devices~~device’s ~~and services~~registration.

~~Our~~After ~~ICL~~approval, ~~products~~in ~~generally~~case ~~are~~of ~~not~~substantial ~~covered~~changes byto ~~third-party~~the ~~payers~~design, ~~and~~raw ~~patients~~materials, ~~incur~~manufacturing ~~out-of-pocket~~process, ~~costs~~and ~~for~~indications, ~~these~~among ~~products~~other ~~and~~things, ~~related~~that ~~procedures~~may ~~using~~affect ~~our~~the ~~products.~~medical ~~Our~~device's ~~cataract~~safety ~~IOL~~and ~~products~~effectiveness, ~~used~~the inmanufacturer ~~cataract~~applies ~~procedures~~to ~~generally~~NMPA ~~are~~for ~~covered~~approval byof ~~third-party~~such ~~payers~~registration inchanges. ~~whole~~In orcase inof ~~part~~minor ~~depending~~changes ~~upon~~that ado ~~variety~~not ofaffect ~~factors, including~~ the ~~specific~~medical ~~product~~device's ~~used~~safety and ~~geographic~~effectiveness, ~~location where~~ the ~~procedure~~manufacturer ~~using~~submits ~~the~~a ~~covered~~change ~~product~~notification isto ~~performed~~NMPA. ~~The market for some of our IOL products therefore is influenced by third-party payers’ policies.~~

~~Other~~While ~~Regulations~~STAAR Surgical AG and STAAR Surgical Company hold the licenses, STAAR China serves as a local agent. The local agent is authorized to submit the registration application materials to NMPA, provides maintenance support and technical service, and oversees the registration and clinical trial process. Under the Measures for Adverse Event Monitoring and Reevaluation of Medical Devices (Decree No. 1), Medical Device Adverse Event Reporting and Reevaluation, the license holder bears the primary responsibility for monitoring medical device adverse events (AEs) and establishing an AE monitoring system. The local agent helps manage AEs in case of device malfunction.

~~Our~~The ~~business~~license ~~and~~holder ~~our ICL products are subject to extensive regulation by numerous other governmental agencies, both within the U.S.~~ and ~~internationally.~~local Inagent ~~the U.S., apart from the agencies discussed above, our facilities, operations, employees, and products~~ are ~~regulated~~responsible byfor ~~the~~carrying ~~Environmental~~out ~~Protection~~self-inspection ~~Agency, the Occupational Health & Safety Administration, the Department~~ of ~~Labor,~~ the ~~Department~~quality ofmanagement ~~Commerce,~~system ~~the Department of Treasury, the Department of Justice and others~~periodically. ~~State~~They ~~agencies~~are also ~~regulate~~responsible ~~our~~for ~~facilities~~identifying, ~~operations~~monitoring, ~~employees,~~ and ~~products~~trending ~~within~~adverse ~~their~~events ~~respective~~related states. Government agencies internationally also regulate public health, product registration, manufacturing, environmental conditions, labor, exports, imports, bribery and corruption and other aspects of our global operations. Any failure to ~~comply~~the ~~with~~medical applicable legal and regulatory obligations could result in fines and penalties, restrictions on certain business activities, and other remedial measures, which if significant, could disrupt our operations, distract management, and harm our businessdevice.

~~The~~In ~~advertising~~Korea, ~~and~~a ~~promotion~~registration of ~~our~~medical ~~ICL~~devices ~~products~~such as our ICLs is ~~also~~overseen ~~subject~~by tothe ~~extensive~~Ministry ~~regulation,~~of ~~which~~Food ~~can~~and ~~vary~~Drug ~~significantly~~Safety ~~from~~(MFDS) ~~country~~pursuant to ~~country~~the Medical Device Act. InThe Medical Device Safety Bureau of the ~~U.S.~~MFDS holds primary responsibility for medical device regulations, while departments within the ~~FDA~~National Institute of Food and ~~the~~Drug ~~Federal~~Safety ~~Trade~~Evaluation ~~Commission~~(NIFDS) ~~regulate~~oversee the ~~advertising~~evaluation and ~~promotion~~research of ~~our~~medical ~~products~~devices. ~~and~~Medical devices require ~~that~~registration and/or approval prior to commercialization. In Korea, medical device classification closely follows the ~~claims~~Global weHarmonization ~~make~~Task ~~are~~Force ~~consistent~~(GHTF) Classification guidelines, with ~~our~~Class ~~regulatory~~I, ~~clearances~~II, III and ~~approvals~~IV designations being ranked from low- to high-risk categorization. The registration review route depends on the risk classification of the device. Typically, ~~that~~the ~~there~~MFDS isrequires ~~adequate~~similar ~~and~~documentation ~~reasonable~~as ~~data~~required to ~~substantiate~~obtain a CE Mark. Our distributor in Korea is contractually required to obtain, with our assistance, the ~~claims~~necessary health registrations, governmental approvals, or clearances to import, market and ~~that~~sell our ~~promotional~~products. ~~labeling~~In Korea, we provide our distributor with information and ~~advertising~~data isto ~~neither~~obtain ~~false~~appropriate ~~nor~~registrations ~~misleading~~and approvals, and the distributor obtains such registrations. ~~Many~~In ~~international~~addition ~~regulators~~to ~~impose~~the ~~similar~~device ~~requirements~~registration, ~~but~~MFDS ~~some~~requires ~~jurisdictions~~all ~~impose~~devices ~~significant~~Class ~~restrictions~~II onand ~~the~~above ~~ability~~to ofcomply ~~medical~~with ~~device~~Korean ~~companies~~Good Manufacturing Practice (KGMP) quality system standards in order to ~~engage~~be marketed in ~~advertising~~Korea. ~~and~~KGMP ~~promotion~~standards ~~activities~~are based on, but not identical to, ISO 13485 quality system standards. ~~Because~~Therefore, ISO 13485 certificates issued by a ~~key~~notified ~~element~~body ofin ~~our~~the ~~growth~~EU ~~strategy~~will isnot be sufficient. To obtain KGMP certification, documents that pertain to ~~drive~~all ~~awareness~~areas of ~~the~~compliance, ~~ICL~~including ~~procedure~~design, risk assessment, technical requirements and any other quality system requirements, need to be submitted to an MFDS-authorized conformity assessment body. Our distributor in Korea submits the ~~clinical~~application ~~benefits~~on behalf of ~~our~~STAAR. ~~ICLs~~After the application is submitted, ~~limitations~~the onmanufacturing ~~our~~site ~~ability~~undergoes toeither ~~advertise~~a ~~and~~paper ~~promote~~audit ~~our~~or ~~ICL~~an ~~products~~onsite ~~could~~inspection/audit ~~harm~~by ~~our~~an ~~business~~authorized third party and MFDS. Medical device registration licenses do not expire, but the KGMP certificate must be renewed every three years.

InIf ~~addition, we are subject to U.S. federal and state and foreign data privacy, security and data breach notification laws governing~~ the ~~collection,~~NMPA ~~use,~~or ~~disclosure~~MFDS ~~and~~were ~~protection~~to ofconclude ~~health-related~~that ~~and~~we ~~other~~are ~~personal~~not ~~information.~~in Incompliance ~~the~~with ~~U.S.,~~applicable ~~numerous federal and state~~ laws ~~and~~or regulations, ~~including~~or ~~data~~that ~~breach~~any ~~notification~~of ~~laws,~~our ~~health~~medical ~~information~~devices ~~privacy~~are ~~and~~ineffective ~~security~~or ~~laws~~pose ~~and~~an ~~consumer~~unreasonable ~~protection laws and regulations govern the collection, use, disclosure, and protection of~~ health~~-related~~ ~~and other personal information. In addition~~risk, ~~certain~~they ~~foreign~~could ~~laws~~take ~~govern~~a ~~the~~variety ~~privacy and security~~ of personal data, including health-related data. Privacy and security laws, regulations, and other obligations are constantly evolving, may conflict with each other to complicate compliance efforts, and can result in investigations, proceedings, or actions that lead to significant civil and/or criminal penalties and restrictions on data processing.

~~Research and Development~~14

Weregulatory ~~focus~~or onlegal ~~furthering~~actions ~~technological advancements~~ in ~~the~~their ~~ophthalmic~~respective ~~products~~countries, ~~industry~~similar ~~through~~to the ~~development~~U.S. ~~of innovative premium ophthalmic products (lenses and accessory delivery systems)~~FDA, ~~materials~~which ~~and~~could ~~designs.~~have Wea ~~maintain~~material ~~active internal research~~ and ~~development~~negative ~~programs.~~impact Toon ~~achieve~~the ~~our business objectives, we will continue our investment in research and development~~Company.

~~During~~Third-Party ~~2025,~~Coverage ~~we intend to continue our focus on research~~ and ~~development in the following areas:~~Reimbursement.

~~Development~~Health-care ofproviders ~~new~~generally ~~presbyopia~~rely on third-~~correcting~~party ~~phakic~~payers, ~~intraocular~~including ~~lenses~~governmental ~~that~~payers ~~simultaneously~~such ~~correct~~as ~~sphere~~Medicare and ~~cylinder~~Medicaid, (iprivate insurance plans and workers’ compensation plans, to cover and reimburse the cost of medical devices and related services.e. These third-party payers may deny coverage or reimbursement for a medical device if they determine that the product or procedure using the product was not medically appropriate or necessary, ~~astigmatism);~~and they are increasingly challenging the price of medical devices and services.

~~Development~~Our ofICL ~~preloaded~~products ~~injector~~generally ~~systems~~are not covered by third-party payers, and patients incur out-of-pocket costs for ~~ophthalmic~~these ~~medical~~products ~~devices;~~and related procedures using our products. Our cataract IOL products used in cataract procedures generally are covered by third-party payers in whole or in part depending upon a variety of factors, including the specific product used and geographic location where the procedure using the covered product is performed. The market for some of our IOL products therefore is influenced by third-party payers’ policies.

~~Development~~Other ~~of a new generation of ophthalmic medical devices and materials~~Regulations.

14Our business and our ICL products are subject to extensive regulation by numerous other governmental agencies, both within the U.S. and internationally. In the U.S., apart from the agencies discussed above, our facilities, operations, employees, and products are regulated by the Environmental Protection Agency, the Occupational Safety and Health Administration (OSHA), the Department of Labor, the Department of Commerce, the Department of the Treasury, the Department of Justice and others. State agencies also regulate our facilities, operations, employees, and products within their respective states. Government agencies internationally also regulate public health, product registration, manufacturing, environmental conditions, labor, exports, imports, bribery and corruption and other aspects of our global operations. Any failure to comply with applicable legal and regulatory obligations could result in fines and penalties, restrictions on certain business activities, and other remedial measures, which if significant, could disrupt our operations, distract management, and harm our business.

~~Environmental~~The ~~Matters~~advertising and promotion of our ICL products is also subject to extensive regulation, which can vary significantly from country to country. In the U.S., the FDA and the Federal Trade Commission regulate the advertising and promotion of our products and require that the claims we make are consistent with our regulatory clearances and approvals, that there is adequate and reasonable data to substantiate the claims and that our promotional labeling and advertising is neither false nor misleading. Many international regulators impose similar requirements, but some jurisdictions impose significant restrictions on the ability of medical device companies to engage in advertising and promotion activities. Because a key element of our growth strategy is to drive awareness of the ICL procedure and the clinical benefits of our ICLs, limitations on our ability to advertise and promote our ICL products could harm our business.

WeIn addition, we are subject to U.S. federal, and state, ~~local~~ and foreign ~~environmental~~data ~~laws~~privacy, security and ~~regulations.~~data Webreach ~~believe~~notification ~~that~~laws ~~our~~governing ~~operations~~the ~~comply~~collection, inuse, ~~all~~disclosure ~~material~~and ~~respects~~protection ~~with~~of ~~applicable~~health-related ~~environmental laws~~ and ~~regulations~~other inpersonal ~~each~~information. ~~country~~In ~~where~~the ~~we do business~~U.S., Wenumerous dofederal ~~not~~and ~~expect~~state ~~compliance with these~~ laws toand ~~affect~~regulations, ~~materially~~including ~~our~~data ~~capital~~breach ~~expenditures,~~notification ~~earnings~~laws, orhealth ~~competitive~~information ~~position.~~privacy Weand ~~have~~security nolaws ~~plans~~and toconsumer ~~invest~~protection inlaws ~~material~~and ~~capital~~regulations ~~expenditures~~govern ~~for~~the ~~environmental~~collection, ~~control~~use, ~~facilities~~disclosure, ~~for~~and ~~the~~protection ~~remainder~~ of ~~our~~health-related ~~current~~and ~~fiscal~~other ~~year~~personal information. WeIn ~~are not aware of any pending actions~~addition, ~~litigation~~certain orforeign ~~significant~~laws ~~financial~~govern ~~obligations~~the ~~arising~~privacy ~~from~~and ~~current~~security orof ~~past~~personal ~~environmental~~data, ~~practices~~including ~~that~~health-related ~~are~~data. ~~likely~~Privacy toand ~~have~~security alaws, ~~material~~regulations, ~~adverse~~and ~~impact~~other onobligations ~~our~~are ~~financial~~constantly ~~position. However~~evolving, ~~environmental~~may ~~problems~~conflict ~~relating~~with toeach ~~our~~other ~~properties~~to ~~could~~complicate ~~develop~~compliance ~~in the future~~efforts, and ~~such~~can ~~problems~~result ~~could~~in ~~require~~investigations, ~~significant expenditures. In addition~~proceedings, ~~we cannot predict changes in environmental legislation~~ or ~~regulations~~actions that ~~may~~lead beto ~~adopted~~significant civil and/or ~~enacted~~criminal inpenalties ~~the future~~ and ~~that~~restrictions ~~may~~on ~~adversely~~data ~~affect us~~processing.

WeResearch ~~seek to achieve our corporate goals in an environmentally sustainable manner. Our most recent Sustainability Report, which includes information about our approach to environmental, social~~ and governance (or “ESG”) at STAAR, is available in the Investors section of our website, www.staar.com, under the Sustainability tab. We established a cross-functional climate risk committee to identify the risks presented by climate change and opportunities to reduce our environmental impact. STAAR has undertaken several projects designed to reduce energy and waste, such as our investment in solar photovoltaic panels at three locations in California (our principal manufacturing facility in Monrovia, our precision manufacturing center of excellence facility in Lake Forest, and our technology center in Tustin). Development

~~Human~~We ~~Capital~~focus on furthering technological advancements in the ophthalmic products industry through the development of innovative premium ophthalmic products (lenses and accessory delivery systems), materials and designs. We maintain active internal research and development programs. To achieve our business objectives, we will continue our investment in research and development.

~~Our~~During ~~goal is to develop~~2026, manufacture and sell ophthalmic products throughout the world as primary and premium solutions for patients seeking visual freedom from wearing eyeglasses or contact lenses while achieving excellent visual acuity through refractive vision correction. To achieve our goal, we ~~continually~~intend ~~seek~~ to ~~attract,~~continue ~~develop~~our ~~and~~focus ~~retain~~on ~~talented~~research ~~people. We strive to make STAAR a diverse, inclusive, safe workplace, with opportunities for employees to grow~~ and ~~develop~~development ~~their~~in ~~careers.~~the Wefollowing ~~offer competitive compensation and benefits.~~areas:

•

AsDevelopment of ~~December~~new ~~27,~~presbyopia-correcting ~~2024,~~phakic weintraocular ~~had~~lenses ~~approximately~~that ~~1,211~~simultaneously ~~employees,~~correct ofsphere ~~which 404 were employed outside the U.S. Of the 1,211 employees, 1,157 were regular full-time,~~ and 54cylinder ~~were temporary. In fiscal year 2024, we added approximately 262 employees~~ (~~including 54 temporary employees)~~i. ~~Our global overall turnover rate in fiscal year 2024 was approximately 7~~e.~~6% (excluding temporary employees)~~, ~~below the overall turnover rate of approximately 18.9% in the medical device industry. Management periodically provides human capital management updates and data to our Board of Directors.~~astigmatism);

•

~~The~~Development ~~health and safety~~ of ~~our~~preloaded ~~employees~~injector issystems afor ~~top~~ophthalmic ~~priority.~~medical Wedevices; ~~created~~ and we follow various safety policies and procedures, and we offer health insurance and wellness programs. We invest in our employees by offering numerous training opportunities, such as to teach new skills, provide career development opportunities and communicate expectations regarding business conduct and ethics. In addition to salaries, we provide additional compensation and benefits programs (which vary by country) such as cash bonuses, stock awards, a 401(k) plan, health insurance benefits, health savings and flexible spending accounts, paid time off, family leave, and employee assistance programs, among others.

•

~~Additional~~Development ~~Information~~of a new generation of ophthalmic medical devices and materials.

We make available free of charge through our website, www.staar.com, our Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and amendments to any reports filed or furnished pursuant to Section 13(a) of the Securities Exchange Act of 1934, as soon as reasonably practicable, after those reports are filed with or furnished to the Securities and Exchange Commission (SEC).15

~~The~~Environmental SEC maintains an Internet site that contains reports, proxy and information statements, and other information regarding STAAR and other issuers that file electronically with the SEC at http://www.sec.gov.Matters

~~Glossary~~We are subject to federal, state, local and foreign environmental laws, and regulations. We believe that our operations comply in all material respects with applicable environmental laws and regulations in each country where we do business. We do not expect compliance with these laws to affect materially our capital expenditures, earnings, or competitive position. We have no plans to invest in material capital expenditures for environmental control facilities for the remainder of our current fiscal year. We are not aware of any pending actions, litigation or significant financial obligations arising from current or past environmental practices that are likely to have a material adverse impact on our financial position. However, environmental problems relating to our properties could develop in the future, and such problems could require significant expenditures. In addition, we cannot predict changes in environmental legislation or regulations that may be adopted or enacted in the future and that may adversely affect us.

~~The~~We ~~following~~seek ~~glossary~~to isachieve ~~intended~~our corporate goals in an environmentally sustainable manner. Our most recent Sustainability Report, which includes information about our approach to ~~help~~environmental, ~~the~~social ~~reader~~and ~~understand~~governance ~~some~~(or “ESG”) at STAAR, is available in the Investors section of our website, www.staar.com, under the ~~terms~~Sustainability ~~used~~tab. We established a cross-functional climate risk committee to identify the risks presented by climate change and opportunities to reduce our environmental impact. STAAR has undertaken projects designed to reduce energy and waste, such as our investment in ~~this~~solar ~~Annual~~photovoltaic ~~Report~~panels at several locations in California, including our principal manufacturing facility in Monrovia, CA.

~~acrylic~~Human ~~– a broadly used family of plastics. Acrylic materials used in IOLs have been both water repelling (hydrophobic) and water-absorbing (hydrophilic).~~ Capital

15Our goal is to develop, manufacture and sell ophthalmic products throughout the world as primary and premium solutions for patients seeking visual freedom from wearing eyeglasses or contact lenses while achieving excellent visual acuity through refractive vision correction. To achieve our goal, we continually seek to attract, develop and retain talented people. We strive to make STAAR a diverse, inclusive, safe workplace, with opportunities for employees to grow and develop their careers. We offer competitive compensation and benefits.

~~aspheric~~As –of ~~aspheric~~January ~~lenses~~2, ~~are~~2026, ~~lenses~~we ~~that~~had ~~are~~approximately ~~designed~~957 inemployees, aof ~~shape~~which ~~that~~406 ~~creates~~were aemployed ~~more~~outside ~~clearly~~the ~~focused~~U.S. ~~image~~Of ~~than~~the ~~traditional~~957 ~~spheric~~employees, ~~lenses~~921 were regular full-time, and 36 were temporary. ByIn ~~reducing~~fiscal ~~spherical~~year ~~aberrations~~2025, ~~IOLs~~we ~~that~~took ~~feature~~a ~~aspheric~~number ~~optics~~of ~~generally~~steps ~~deliver~~to change our leadership team, realign our leadership structure to better ~~night~~address ~~vision~~market needs, reduce costs and ~~contrast~~discretionary ~~sensitivity~~spending, and better position the Company to return to sustainable growth. As a result, our global overall turnover rate in fiscal year 2025 was approximately 32.2% (excluding temporary employees), which is higher than ~~spheric~~the ~~IOLs~~overall turnover rate of approximately 19.7% in the medical device industry. Management periodically provides human capital management updates and data to our Board of Directors.

~~collagen~~The ~~copolymer~~health -and ~~compounds~~safety ~~formed~~of our employees is a top priority. We created and we follow various safety policies and procedures, and we offer health insurance and wellness programs. We invest in our employees by ~~joining~~offering ~~molecules~~numerous oftraining ~~collagen~~opportunities, ~~derived~~such ~~from~~as ~~biological~~to ~~sources~~teach ~~with~~new ~~synthetic~~skills, ~~monomer~~provide ~~molecules~~career development opportunities and communicate expectations regarding business conduct and ethics. ~~STAAR’s~~In ~~proprietary~~addition ~~Collamer~~to ~~material~~salaries, iswe provide additional compensation and benefits programs (which vary by country) such as cash bonuses, stock awards, a ~~collagen~~401(k) ~~copolymer~~plan, ~~engineered~~health ~~specifically~~insurance ~~for~~benefits, ~~use~~health insavings ~~implantable~~and ~~lenses~~flexible spending accounts, paid time off, family leave, and employee assistance programs, among others.

~~contrast~~Additional ~~sensitivity - the ability to visually distinguish an object from its background.~~Information

~~crystalline~~We ~~lens~~make –available ~~the~~free ~~natural~~of ~~lens~~charge ~~that~~through isour ~~present~~website, inwww.staar.com, ~~the~~our ~~eye~~Annual atReport ~~birth~~on Form 10-K, ~~which~~Quarterly isReports aon ~~clear~~Form ~~structure~~10-Q, ~~located~~Current ~~behind~~Reports ~~the~~on ~~iris~~Form ~~that~~8-K ~~changes~~and ~~shape~~amendments to ~~focus~~any ~~light~~reports ~~onto~~filed or furnished pursuant to Section 13(a) of the ~~retina~~Securities Exchange Act of 1934, as soon as reasonably practicable, after those reports are filed with or furnished to the Securities and Exchange Commission (SEC).

~~excimer~~The ~~laser~~SEC –maintains aan ~~specialized~~Internet ~~ultraviolet~~site ~~laser~~that ~~used~~contains inreports, ~~ophthalmology~~proxy toand ~~cut~~information orstatements, ~~shape~~and ~~eye~~other ~~tissue.~~information ~~The~~regarding ~~excimer~~STAAR ~~laser~~and isother ~~used~~issuers ~~during~~that ~~LASIK~~file electronically with the SEC at http://www.sec.gov. Websites referenced herein, and ~~PRK~~the ~~surgery~~information contained on or connected to such websites, are not incorporated into this Annual Report on Form 10-K.

~~foldable IOL – an intraocular lens made of flexible material, which can be inserted with an injector system through a small incision in minimally invasive eye surgery.~~Glossary

~~hyperopia~~The –following ~~the~~glossary ~~refractive~~is ~~disorder~~intended ~~commonly~~to ~~known~~help ~~as farsightedness, which occurs when~~ the ~~eye’s~~reader ~~lens~~understand ~~focuses~~some ~~images behind the plane~~ of the ~~retina~~terms ~~rather~~used ~~than on the retinal surface. An adult with moderate to high hyperopia cannot see close objects without eyeglasses or contact lenses. Because presbyopia often results~~ in ~~the~~this ~~need~~Annual ~~for reading glasses, it is sometimes confused with farsightedness~~Report.

~~intraocular~~acrylic – ~~within~~a ~~the~~broadly ~~eye~~used family of plastics. Acrylic materials used in IOLs have been both water repelling (hydrophobic) and water-absorbing (hydrophilic).

~~injector or injector system – a device in the form of a syringe that is used to deliver a foldable IOL into the eye through a slender nozzle in minimally invasive eye surgery.~~16

~~iridotomy~~aspheric – aaspheric ~~small~~lenses ~~hole~~are ~~created~~lenses inthat ~~the~~are ~~iris,~~designed ~~usually~~in ~~made with~~ a ~~YAG~~shape ~~laser.~~that ~~Prior~~creates ~~to implantation of some ICL models~~ a ~~YAG~~more ~~peripheral~~clearly ~~iridotomy~~focused isimage ~~made~~than intraditional anspheric ~~unobtrusive area at the periphery of the iris to ensure continued fluid flow in the eye after implantation~~lenses. ~~The~~By ~~ICL~~reducing ~~with~~spherical ~~CentraFLOW technology~~aberrations, ~~marketed~~IOLs ~~with~~that ~~the~~feature ~~brand~~aspheric ~~names~~optics ~~EVO~~generally ~~and~~deliver ~~EVO+,~~better ~~have~~night avision ~~central~~and ~~port~~contrast ~~for~~sensitivity ~~fluid~~than ~~flow,~~spheric ~~which eliminates the need for an iridotomy or iridectomy~~IOLs.

~~LASIK~~collagen –copolymer ~~an acronym for laser~~-~~assisted~~ ~~in-situ~~compounds ~~keratomileusis,~~formed aby ~~surgical~~joining ~~operation~~molecules ~~that~~of ~~reshapes~~collagen ~~the~~derived ~~cornea~~from tobiological ~~correct~~sources ~~nearsightedness,~~with ~~farsightedness,~~synthetic ormonomer ~~astigmatism~~molecules. ~~LASIK~~STAAR’s ~~involves~~proprietary ~~first~~Collamer ~~the~~material ~~cutting~~is of a ~~hinged~~collagen ~~flap~~copolymer toengineered ~~separate~~specifically ~~the~~for ~~surface~~use ~~layer~~in ofimplantable ~~the cornea, using a microkeratome (a special blade) or a laser~~lenses. ~~An excimer laser is then used to ablate tissue and reshape the inner cornea, after which the flap is returned to position.~~

~~myopia~~contrast –sensitivity ~~the~~- ~~refractive disorder also known as nearsightedness, which occurs when~~ the ~~eye’s~~ability ~~lens~~to ~~focuses~~visually ~~images~~distinguish inan ~~front~~object offrom ~~the~~its ~~retina rather than on the retinal surface~~background. ~~A person with myopia cannot clearly see distant objects without eyeglasses or contact lenses.~~

~~ophthalmologist~~crystalline lens – athe ~~surgeon~~natural ~~who~~lens ~~specializes~~that is present in the ~~diseases~~eye ~~and~~at ~~disorders~~birth, ofwhich ~~the~~is ~~eye~~a ~~and~~clear structure, located behind the ~~related~~iris ~~visual~~that ~~pathway~~changes shape to focus light onto the retina.

~~ophthalmic~~excimer laser – ofa orspecialized ~~related~~ultraviolet laser used in ophthalmology to ~~the~~cut or shape eye tissue. The excimer laser is used during LASIK and PRK surgery.

~~optic~~foldable IOL – ~~the~~an ~~central~~intraocular ~~part~~lens made of anflexible ~~IOL~~material, orwhich ~~ICL,~~can ~~the~~be ~~part~~inserted ~~that~~with ~~functions~~an asinjector system through a ~~lens~~small ~~and~~incision ~~focuses~~in ~~images~~minimally oninvasive ~~the~~eye ~~retina~~surgery.

~~PRK~~hyperopia – anthe ~~acronym~~refractive ~~for~~disorder ~~photorefractive~~commonly ~~keratectomy~~known as farsightedness, which occurs when the ~~first~~eye’s ~~type~~lens focuses images behind the plane of ~~laser~~the ~~surgical~~retina ~~operation~~rather than on the retinal surface. An adult with moderate to ~~correct~~high ~~nearsightedness,~~hyperopia ~~farsightedness,~~cannot see close objects without eyeglasses or ~~astigmatism~~contact lenses. Because presbyopia often results in the need for reading glasses, it is sometimes confused with farsightedness.

~~preloaded~~ injector -or aninjector ~~IOL~~system ~~packaged~~– ~~and~~a ~~shipped~~device in athe ~~pre-sterilized,~~form ~~disposable~~of ~~injector.~~a ~~This~~syringe ~~differs~~that ~~from~~is ~~the~~used ~~conventional~~to ~~method~~deliver ofa ~~packaging~~foldable ~~IOLs,~~IOL ~~which~~into ~~requires~~ the ~~surgeon~~eye orthrough ana ~~assistant~~slender tonozzle ~~manually~~in ~~load~~minimally ~~each~~invasive ~~lens~~eye ~~into an injector before~~ surgery.

~~presbyopia~~intraocular – anwithin ~~age-related condition in which~~ the ~~crystalline lens loses its ability to focus on both near and far objects~~eye. ~~People who have had normal vision will typically begin to need eyeglasses for reading or other close tasks at some point after age 40 due to presbyopia.~~

~~QSR~~iridotomy -– a small hole created in the Uiris, usually made with a YAG laser.S. ~~FDA’s~~Prior ~~Quality~~to ~~System~~implantation ~~Regulation,~~of orsome ~~current~~ICL ~~Good~~models ~~Manufacturing~~a ~~Practice~~YAG ~~(cGMP)~~peripheral ~~regulation,~~iridotomy ~~includes~~is ~~requirements~~made ~~related~~in toan unobtrusive area at the ~~methods~~periphery ~~used~~of ~~in,~~the ~~and~~iris to ensure continued fluid flow in the ~~facilities~~eye ~~and~~after ~~controls~~implantation. ~~used~~The ~~for,~~ICL ~~designing,~~with ~~manufacturing,~~CentraFLOW ~~packaging~~technology, ~~labeling,~~marketed ~~storing,~~with ~~installing,~~the brand names EVO and ~~servicing~~EVO+, ofhave ~~medical~~a ~~devices~~central ~~intended~~port for ~~human~~fluid ~~use.~~flow, ~~The~~which ~~regulation~~eliminates ~~sets~~the need for an iridotomy or iridectomy.

16LASIK – an acronym for laser-assisted in-situ keratomileusis, a surgical operation that reshapes the cornea to correct nearsightedness, farsightedness, or astigmatism. LASIK involves first the cutting of a hinged flap to separate the surface layer of the cornea, using a microkeratome (a special blade) or a laser. An excimer laser is then used to ablate tissue and reshape the inner cornea, after which the flap is returned to position.

~~forth~~myopia – the ~~framework~~refractive ~~for~~disorder ~~medical~~also ~~device~~known ~~manufacturers~~as tonearsightedness, ~~follow~~which inoccurs ~~achieving~~when ~~quality~~the ~~requirements,~~eye’s ~~including~~lens ~~requirements~~focuses ~~related~~images toin ~~complaint~~front ~~handling~~of ~~and~~the ~~control~~retina ofrather ~~purchased~~than oron ~~supplied~~the ~~services,~~retinal ~~components,~~surface. ~~and~~A ~~materials~~person ~~bearing~~with onmyopia ~~the~~cannot ~~quality~~clearly ofsee ~~medical~~distant ~~devices~~objects without eyeglasses or contact lenses.

~~RLE~~ophthalmic – ~~refractive~~of ~~lens~~or ~~exchange,~~related ato ~~refractive surgical procedure in which~~ the ~~natural crystalline lens is removed and replaced with an IOL (essentially the same as cataract surgery but performed primarily to address refractive issues not to remove a cataract)~~eye.

~~refractive~~ophthalmologist ~~market~~ – asa ~~used~~surgeon inwho ~~this~~specializes ~~report~~in ~~“refractive market” means~~ the ~~overall~~diseases ~~market~~and ~~volume~~disorders ~~for refractive surgical procedures~~ of ~~all kinds, including LASIK, PRK, RLE,~~ the ~~ICL~~eye ~~product family~~ and ~~other phakic IOLs. As used in this Annual Report,~~ the ~~term~~related ~~does~~visual ~~not include sales of non-surgical products like eyeglasses and contact lenses~~pathway.

~~silicone~~optic – athe ~~type~~central part of ~~plastic~~an ~~often~~IOL ~~used~~or inICL, ~~implantable~~the ~~devices~~part that isfunctions ~~inert,~~as ~~generally~~a ~~flexible~~lens and ~~water-repelling~~focuses images on the retina.

~~spheric~~preloaded ~~lenses~~injector –- an IOL packaged and shipped in a ~~spheric~~pre-sterilized, ~~lens~~disposable ~~has~~injector. ~~surfaces~~This ~~that~~differs ~~are~~from ~~shaped~~the ~~like~~conventional ~~sections~~method of apackaging ~~sphere.~~IOLs, which requires the surgeon or an assistant to manually load each lens into an injector before surgery.

~~toric~~PRK – ~~refers~~an toacronym for photorefractive keratectomy, the ~~shape~~first type of alaser ~~lens~~surgical ~~designed~~operation to correct ~~astigmatism~~nearsightedness, ~~which~~farsightedness, ~~has~~or ~~greater refractive power in some sections of the lens than others~~astigmatism.

~~YAG~~presbyopia – an ~~acronym~~age-related ~~for~~condition ~~yttrium-aluminum-garnet,~~in awhich ~~mineral~~the ~~crystal.~~crystalline ~~Lasers~~lens ~~using~~loses ~~neodymium-doped~~its ~~yttrium~~ability ~~aluminum~~to ~~garnet~~focus ~~crystals~~on ~~(Nd:YAG)~~both ~~generate~~near aand ~~high-energy~~far ~~beam~~objects. ~~that~~People ~~can~~who behave ~~used~~had innormal avision ~~number~~will oftypically ~~ophthalmic~~begin ~~procedures,~~to ~~including~~need ~~creating~~eyeglasses ~~iridotomies~~for ~~before~~reading ~~implantation~~or ofother close tasks at some ~~models~~point ofafter ~~the~~age ~~ICL~~40 due to presbyopia.

~~ITEM~~QSR 1A- the U. ~~Risk~~S. ~~Factors~~FDA’s Quality System Regulation, or current Good Manufacturing Practice (cGMP) regulation, includes requirements related to the methods used in, and the facilities and controls used for, designing, manufacturing, packaging, labeling, storing, installing, and servicing of medical devices intended for human use. The regulation sets

Investment in our securities involves a high degree of risk. Investors should carefully consider the following risk factors, in addition to other information contained in this Annual Report and other filings that we make from time to time with the SEC, before making a decision to invest in our common stock. Any of the following risks, as well as other risks that we cannot foresee at this time or that we currently view to be immaterial, could materially and adversely affect our business, financial condition, results of operations or cash flows. The trading price of our common stock could decline due to any of these risks, and investors may lose all or part of their investment. This Annual Report contains forward-looking statements that involve risks and uncertainties. Actual results could differ materially from those anticipated or implied in these forward-looking statements because of factors beyond our control, including the risks faced by us described below. Moreover, except where the risk factors below specifically describe factors, events, or contingencies as having occurred, these risk factors are not representations of whether the factors, events, or contingencies mentioned have or have not occurred. Instead, they reflect our beliefs and opinions as to the factors, events, or contingencies that could adversely affect us in the future.17

~~Risks~~forth ~~Related~~the framework for medical device manufacturers to ~~Our~~follow ~~Business~~in achieving quality requirements, including requirements related to complaint handling and control of purchased or supplied services, components, and materials bearing on the quality of medical devices.

Werefractive ~~reported~~market a– ~~decrease~~as used in ~~revenue~~this report “refractive market” means the overall market volume for refractive surgical procedures of all kinds, including LASIK, PRK, SMILE, RLE, the ICL product family and aother ~~net~~phakic ~~loss~~IOLs. As used in ~~fiscal~~this ~~2024~~Annual Report, ~~and~~the weterm ~~may~~does not beinclude ~~able~~sales toof ~~return~~non-surgical toproducts ~~our~~like ~~growth~~eyeglasses and ~~profitability~~contact ~~trajectory~~lenses.

~~For~~RLE ~~the~~– ~~fiscal~~refractive ~~year~~lens ~~ended December 27~~exchange, ~~2024, we reported $313.9 million of net sales,~~ a ~~decrease~~refractive ofsurgical 3%procedure ~~compared to $322.4 million~~ in ~~fiscal~~which 2023, and we incurred a net loss of $20.2 million compared to net income of $21.3 million in fiscal 2023. Prior to fiscal 2024, we had reported over ten years of annual net sales growth, and we had delivered net income profitability since 2018. Our results in fiscal 2024 were negatively impacted by a significant decline in ICL sales in China in the ~~fourth~~natural ~~quarter~~crystalline ~~ended~~lens ~~December~~is ~~27,~~removed ~~2024. We believe the sluggish economy~~ and ~~weak~~replaced ~~consumer~~with ~~consumption~~an ~~that~~IOL ~~contributed~~(essentially ~~to fluctuating demand for ICL procedures in China in fiscal 2024 will continue in fiscal 2025, and we cannot predict when~~ the ~~macroeconomic~~same ~~conditions~~as ~~will~~cataract ~~improve~~surgery inbut ~~China~~performed orprimarily ~~whether the demand for ICL procedures in China will return~~ to ~~historical~~address ~~levels~~refractive inissues ~~the~~not ~~foreseeable future. While we intend~~ to ~~return~~remove toa ~~sales growth and profitability in the future, there can be no guarantee that we will achieve our growth and profitability plans~~cataract). ~~Further, our growth and profitability are challenged by the competitive nature of our industry and the other risks to our business detailed herein.~~

~~Our~~silicone ~~reliance~~– ona ~~independent~~type ~~distributors~~of plastic often used in ~~international~~implantable ~~markets~~devices ~~exposes~~that usis toinert, ~~commercial~~generally flexible and ~~other risks~~water-repelling.

~~Outside~~SMILE ~~the~~– ~~U.S.,~~an ~~except~~acronym for ~~our~~small ~~direct~~incision ~~commercial~~lenticule ~~operations in Japan~~extraction, ~~Germany,~~a ~~Spain,~~surgical ~~Canada,~~operation ~~the~~that ~~U.K.~~reshapes ~~and Singapore, we sell our products through independent distributors who generally control~~ the ~~importation~~cornea ~~and~~for ~~marketing~~refractive ofvision ~~our products within their territories~~correction. WeSMILE ~~generally~~involves ~~grant~~using ~~exclusive~~a ~~rights~~laser to ~~these~~create ~~distributors~~a ~~and~~small ~~rely~~lenticule onof ~~them~~tissue towithin ~~understand~~the ~~local market conditions~~cornea, towhich ~~diligently~~is ~~sell~~then ~~our~~removed ~~products,~~through ~~and~~a totiny ~~comply with local laws and regulations~~incision. ~~Our~~In ~~agreements~~contrast ~~with~~to ~~distributors~~LASIK, ~~and~~the ~~local~~SMILE ~~laws~~procedure ~~can~~does ~~make~~not itrequire ~~difficult~~creating ~~for us to quickly change from~~ a ~~distributor~~corneal ~~who we~~ flap.

17spheric lenses – a spheric lens has surfaces that are shaped like sections of a sphere.

~~feel~~toric is– ~~underperforming.~~refers ~~When we do terminate an independent distributor, which occurs from time~~ to ~~time,~~the weshape ~~may~~of ~~lose~~a ~~customers~~lens ~~who~~designed ~~have been dealing with that distributor and may be required~~ to ~~compensate~~correct ~~the distributor for termination. Because these distributors are independent~~astigmatism, itwhich ~~may~~has begreater ~~difficult~~refractive ~~for~~power ~~us to detect failures~~ in ~~our~~some ~~distributors’~~sections ~~performance~~of ~~or compliance. Actions by independent distributors could result in declining sales in that territory, harm to~~ the ~~reputation~~lens ofthan ~~our company or our products, or legal liability~~others. For example, if our China distributors, which accounted for approximately 51% of our fiscal 2024 consolidated net sales, ceased to serve as our distributors, or significantly underperformed our expectations, we may experience a substantial reduction in sales.

InYAG ~~addition,~~– ~~our~~an ~~distributors~~acronym ~~buy~~for ~~products from us in bulk shipments in advance of anticipated demand~~yttrium-aluminum-garnet, ~~which~~a ~~they~~mineral ~~use~~crystal. toLasers ~~satisfy~~using ~~orders~~neodymium-doped ~~from~~yttrium ~~hospital~~aluminum ~~customers~~garnet ~~based~~crystals on(Nd:YAG) ~~scheduled~~generate ~~surgeries.~~a ~~The~~high-energy ~~timing~~beam ofthat ~~these bulk purchases~~ can ~~create~~be ~~volatility~~used in ~~our~~a ~~revenue~~number ~~and~~of ~~profitability.~~ophthalmic ~~Further~~procedures, ifincluding ~~orders~~creating ~~from~~iridotomies ~~hospital~~before ~~customers~~implantation ~~fall short~~ of ~~anticipated~~some ~~demand,~~models ~~our~~of ~~distributors~~the ~~may have elevated inventories, which could cause them to reduce their future purchases from us until surgical volumes improve~~ICL. If orders from hospital customers exceed anticipated demand, our distributors may not have sufficient inventory and may be unable to satisfy orders from hospital customers for surgical procedures, which could lead to lost sales opportunities.

AITEM slowdown or disruption to the Chinese economy or worsening trade relations between the U1A.S. andRisk China could materially impact our business and results of operations.Factors

~~China~~Investment ~~accounted~~in ~~for~~our ~~approximately~~securities ~~51%~~involves a high degree of ~~our~~risk. ~~fiscal~~Investors ~~2024~~should ~~consolidated~~carefully ~~net~~consider ~~sales.~~the ~~After~~following arisk ~~robust~~factors, ~~start~~in addition to ~~fiscal~~other ~~2024,~~information ~~China~~contained ~~experienced~~in ~~slowing~~this ~~growth~~Annual inReport ~~2024,~~and ~~which~~other ~~some~~filings ~~analysts~~that ~~believe~~we ~~may~~make ~~continue~~from ~~into~~time ~~2025.~~to ~~The~~time ~~sluggish~~with ~~economy~~the ~~and~~SEC, ~~weak~~before ~~consumer~~making ~~consumption~~a decision to invest in ~~China~~our ~~negatively~~common ~~impacted~~stock. Any of the ~~Company’s~~following ~~financial~~risks, ~~results~~as ~~for~~well ~~fiscal~~as ~~2024.~~other Arisks ~~significant~~that we cannot foresee at this time or ~~prolonged~~that ~~slowdown~~we incurrently ~~the~~view ~~Chinese~~to ~~economy~~be immaterial, could materially ~~impact~~and adversely affect our business, ~~and~~financial condition, results of operations inor ~~the~~cash ~~future~~flows. InThe ~~addition~~trading price of our common stock could decline due to any of these risks, ifand ~~social~~investors may lose all or ~~political~~part ~~unrest~~of ~~were~~their toinvestment. ~~disrupt~~This ~~business~~Annual Report contains forward-looking statements that involve risks and uncertainties. Actual results could differ materially from those anticipated or implied in ~~China~~these forward-looking statements because of factors beyond our control, orincluding ifthe ~~other~~risks faced by us described below. Moreover, except where the risk factors below specifically describe factors, events, inor ~~China~~contingencies ~~significantly~~as ~~reduced~~having occurred, these risk factors are not representations of whether the factors, events, or ~~disrupted~~contingencies ~~business~~mentioned ~~activities~~have inor ~~China~~have not occurred. Instead, ~~that~~they ~~may~~reflect ~~materially~~our beliefs and opinions as to the factors, events, or contingencies that could adversely ~~harm~~affect ~~our~~us ~~business.~~in the future.

~~Further,~~Risks ~~changes~~Related in trade restrictions or new or increased tariffs or quotas, embargoes, sanctions, countersanctions, customs restrictions, or other interventions or geopolitical conflicts resulting from deteriorating relations between China and the U.S. would adversely impact our sales and operations in the region. As an example, on February 1, 2025, the U.S. government announced a 10% tariffs on product imports from certain countries, including China. In response, China announced that they would impose counter tariffs of 10% to ~~15%~~Our on select goods imported from the U.S. If maintained, the newly announced tariffs and the potential escalation of trade disputes could pose a significant risk to our business and would affect our sales in China. See the risk factor below captioned “Because our business is global, our sales and profits may fluctuate or decline in response to changes in foreign currency exchange rates and/or other international risks, including tariffs” for a further discussion of the risks from changes to the trade policies and tariffs between the U.S. and China.Business

~~Unfavorable~~We ~~economic~~reported ~~conditions~~a ordecrease ~~negative~~in ~~publicity~~revenue ~~concerning~~and ~~complications~~a ofnet ~~laser~~loss ~~eye~~in ~~surgery~~fiscal 2025 and 2024, orand ~~medical~~we ~~devices~~may innot ~~general,~~be ~~could~~able ~~hurt~~to ~~sales~~return ofto our ~~refractive~~growth ~~products~~and profitability trajectory.

For the fiscal year ended ~~December~~January 272, ~~2024~~2026, ~~approximately~~we ~~100~~reported $239.4 million of net sales, a decrease of 23.7% compared to $313.9 million in fiscal 2024, and we incurred a net loss of ~~our~~$80.4 ~~revenue~~million ~~was~~compared ~~generated~~to ~~from~~a net loss of $20.2 million in fiscal 2024. For the fiscal year ended December 27, 2024, we reported $313.9 million of net sales, a decrease of ~~ICL~~2.6% ~~lenses~~compared ~~used~~to $322.4 million in ~~refractive~~fiscal ~~procedures.~~2023, ~~Refractive~~and ~~surgery~~we isincurred ana ~~elective~~net ~~procedure~~loss ~~generally~~of ~~not~~$20.2 ~~covered~~million bycompared ~~health~~to ~~insurance~~net income of $21.3 ~~Patients~~million ~~must~~in ~~pay~~fiscal ~~for~~2023. ~~the~~Prior ~~procedure~~to fiscal 2024, ~~frequently~~we ~~through~~had ~~installment~~reported ~~financing~~over ~~arrangements~~ten ~~with~~years ~~third~~of ~~parties~~annual net sales growth, and we had delivered net income profitability since 2018. ~~They~~Our ~~can~~results ~~defer~~in fiscal 2024 were negatively impacted by a significant decline in ICL sales in China in the ~~choice~~fourth toquarter ~~have~~ended ~~refractive~~December ~~surgery~~27, if2024. ~~they~~We ~~lack~~believe the ~~disposable~~sluggish ~~income~~economy and weak consumer consumption that contributed to ~~pay~~fluctuating demand for itICL orprocedures doin ~~not~~China ~~feel~~in ~~their~~fiscal ~~income~~2024 isand ~~secure.~~2025 ~~Economic~~will ~~stagnation~~continue in fiscal 2026, ~~lack~~and ofwe ~~consumer~~cannot ~~confidence~~predict when the macroeconomic conditions will improve in China or awhether ~~recession~~the demand for ICL procedures in ~~any~~China will return to historical levels in the foreseeable future. In the first half of fiscal 2025, we took a number of steps to change our ~~larger~~leadership ~~markets~~team, ~~could~~realign ~~slow~~our ~~ICL~~leadership ~~sales~~structure ~~growth~~to orbetter address market needs, ifreduce ~~severe~~costs and discretionary spending, ~~cause~~and ~~declines~~better inposition the Company to return to sustainable growth. As we seek to align our cost structure with our sales forecasts, ~~which~~additional ~~could~~changes ~~materially~~and ~~harm~~further ~~our~~cuts ~~business.~~

We believe that negative publicity in the past regarding the potential complications of refractive surgery and potential patient dissatisfaction, in particular because of LASIK and other corneal laser-based procedures, decreased patient interest in LASIK as well as all other refractive procedures. Depending on the nature and severity of any future negative publicity about refractive surgery, the growth of ICL sales could be limited or could decline due to decreased patient interest in all refractive surgery, including our ICL. 18

~~Disruptions~~may be required. While we intend to return to sales growth and profitability in the future, there can be no guarantee that we will achieve our ~~supply~~growth ~~chain~~and orprofitability ~~failure~~plans. toFurther, ~~adequately~~our ~~forecast~~growth ~~product~~and ~~demand~~profitability ~~could~~are ~~result~~challenged inby ~~significant~~the ~~delays~~competitive ornature ~~lost~~of ~~sales~~our industry and the other risks to our business detailed herein.

~~The~~Our ~~loss~~reliance ofon aindependent ~~material~~distributors ~~supplier could significantly disrupt our business. In some cases, we obtain components used~~ in ~~certain~~international ofmarkets ~~our~~exposes ~~products~~us ~~from single sources. If we experience difficulties acquiring sufficient quantities of required materials or products from our existing suppliers, or if our suppliers are found~~ to becommercial ~~non-compliant~~and ~~with the U.S. FDA’s QSR,~~ other ~~applicable laws, or STAAR’s requirements, then qualifying and obtaining the required~~ risks.

18Outside the U.S., except for our direct commercial operations in Japan, Germany, Spain, Canada, the U.K. and Singapore, we sell our products through independent distributors who generally control the importation and marketing of our products within their territories. We generally grant exclusive rights to these distributors and rely on them to understand local market conditions, to diligently sell our products, and to comply with local laws and regulations. Our agreements with distributors and local laws can make it difficult for us to quickly change from a distributor who we feel is underperforming. When we do terminate an independent distributor, which occurs from time to time, we may lose customers who have been dealing with that distributor and may be required to compensate the distributor for termination. Because these distributors are independent, it may be difficult for us to detect failures in our distributors’ performance or compliance. Actions by independent distributors could result in declining sales in that territory, harm to the reputation of our company or our products, or legal liability. For example, if our China distributors, which accounted for approximately 32% of our fiscal 2025 consolidated net sales, ceased to serve as our distributors, or significantly underperformed our expectations, we may experience a substantial reduction in sales.

~~regulatory~~In ~~approvals~~addition, toour distributors buy products from us in bulk shipments in advance of anticipated demand, which they use ~~alternative~~to ~~suppliers~~satisfy ~~may~~orders befrom ahospital ~~lengthy~~customers based on scheduled surgeries. The timing of these bulk purchases can create volatility in our revenue and ~~uncertain~~profitability. ~~process~~Further, ~~during~~if ~~which~~orders ~~production~~from hospital customers fall short of anticipated demand, our distributors may have elevated inventories, which could because ~~delayed~~them to reduce their future purchases from us until surgical volumes improve. If orders from hospital customers exceed anticipated demand, our distributors may not have sufficient inventory and wemay be unable to satisfy orders from hospital customers for surgical procedures, which could ~~lose~~lead to lost sales opportunities.

~~Our~~A ~~sources~~slowdown ~~of supply for raw materials may be threatened by shortages and other market forces, by natural disasters, climate impacts,~~ or ~~public~~disruption ~~health~~to ~~crises or other disruptive events, or by~~ the ~~supplier’s~~Chinese ~~failure~~economy ~~to maintain adequate quality~~ or aworsening ~~recall~~trade ~~initiated~~relations bybetween the ~~supplier~~U.S. ~~Even when substitute suppliers are available, the need to verify the substitute supplier’s regulatory compliance~~ and ~~the~~China ~~quality standards of the replacement material~~ could ~~significantly delay production and~~ materially ~~reduce~~impact our ~~sales.~~business Inand ~~particular,~~results ~~we manufacture the proprietary collagen-containing raw material used in our ICLs. If the supply~~ of ~~these collagen-containing raw materials is disrupted, it could result in our inability to manufacture our ICL products and would have a material adverse effect on STAAR~~operations.

~~While~~China ~~our~~accounted ~~net~~for ~~sales~~approximately ~~decreased~~32% inof our fiscal ~~2024~~2025 ~~compared~~consolidated tonet ~~fiscal~~sales. ~~2023,~~After wea ~~intend~~robust tostart ~~return~~ to ~~sales~~fiscal ~~growth~~2024, ~~and~~China weexperienced ~~will~~slowing begrowth ~~dependent~~in on2024, ~~our~~which ~~suppliers~~continued tointo ~~help support such growth~~2025. ~~Any~~The ~~failure~~sluggish byeconomy usand toweak ~~forecast~~consumer ~~demand~~consumption ~~for~~in orChina tonegatively ~~maintain~~impacted anthe ~~adequate~~Company’s ~~supply~~financial ~~of,~~results ~~raw~~for ~~material~~fiscal 2024 and ~~finished~~2025. ~~product~~A ~~could~~significant ~~result~~or inprolonged anslowdown ~~interruption~~ in the ~~supply~~Chinese ofeconomy ~~certain~~could ~~products,~~materially ~~which~~impact ~~could~~our ~~impact~~business ~~sales~~and results of ~~that~~operations ~~product.~~in Ifthe ~~our~~future. ~~suppliers~~In oraddition, weif ~~are~~social ~~unable~~ or ~~our~~political ~~suppliers~~unrest ~~are~~were ~~unwilling~~ to ~~meet~~disrupt ~~our~~business ~~increased~~in ~~manufacturing requirements~~China, weor ~~may~~if ~~not~~other beevents ~~able~~in toChina ~~produce~~significantly ~~enough~~reduced ~~materials~~ or ~~products~~disrupted inbusiness aactivities ~~timely~~in ~~manner~~China, ~~which~~that ~~could~~may ~~impact~~materially and adversely harm our ~~sales~~business.

Further, changes in trade restrictions or new or increased tariffs or quotas, embargoes, sanctions, countersanctions, customs restrictions, or other interventions or geopolitical conflicts resulting from deteriorating relations between China and the U.S. would adversely impact our sales and operations in the region. As an example, on February 1, 2025, the U.S. government announced a 10% tariff on product imports from certain countries, including China. In response, China announced that they would impose counter tariffs on select goods imported from the U.S., to which the U.S. responded with heightened reciprocal tariffs. The U.S. and China have reached a one-year agreement with an expiration of November 10, 2026, which includes the continued suspension of the heightened reciprocal tariffs on China and delayed enforcement of new U.S. export rules targeting affiliates of blacklisted firms. If maintained, the newly announced tariffs and the potential escalation of trade disputes could pose a significant risk to our business and would affect our sales in China. See the risk factor below captioned “Because our business is global, our sales and profits may fluctuate or decline in response to changes in foreign currency exchange rates and/or other international risks, including tariffs” for a further discussion of the risks from changes to the trade policies and tariffs between the U.S. and China.

~~Activities~~Unfavorable ~~outside~~economic ~~the~~conditions ~~U.S.~~or ~~accounted~~negative ~~for~~publicity ~~approximately~~concerning ~~94%~~complications of ~~our~~laser ~~total~~eye ~~sales~~surgery, ~~during~~or ~~2024.~~medical ~~Foreign~~devices ~~currency fluctuations could result~~ in volatility of our revenue. The results of operations and the financial position of our Japanese subsidiary are reported in Japanese yen and then translated into U.S. dollars at the applicable exchange rates for inclusion in our consolidated financial statementsgeneral, ~~exposing~~could ushurt ~~to translation risk. In addition, we are exposed to transaction risk because we incur some of our~~ sales and expenses in currencies other than the U.S. dollar. Our most significant currency exposures are to the Japanese yen, the euro, and the Swiss franc, and the exchange rates between these currencies and the U.S. dollar may fluctuate substantially. We do not actively hedge our exposure to currency rate fluctuations. Any strengthening of ~~the U.S. dollar would likely negatively impact~~ our ~~results.~~refractive ~~We price some of our~~ products ~~in U~~.S. dollars, and thus changes in exchange rates can make our products more expensive in some offshore markets and reduce our sales. Inflation could also make our products more expensive and increase the credit risks to which we are exposed. Future foreign currency fluctuations could favorably or unfavorably impact and increase the volatility of our revenue, profitability, and stock price.

~~Economic,~~For ~~social,~~the ~~and~~year ~~political~~ended ~~conditions,~~January ~~laws~~2, ~~practices~~2026, ~~and~~approximately ~~local~~100% ~~customs~~of ~~vary widely among the countries in which we sell~~ our ~~products.~~revenue ~~Our~~was ~~operations~~generated ~~outside~~from ofsales ~~the U.S. face a number~~ of ~~risks~~ICL ~~and~~lenses ~~potential~~used ~~costs,~~in ~~including,~~refractive ~~enjoying~~procedures. ~~less~~Refractive ~~stringent~~surgery ~~protection~~is ofan ~~intellectual~~elective ~~property,~~procedure ~~and~~generally ~~facing~~not ~~economic,~~covered ~~political,~~by ~~and~~health ~~social~~insurance. ~~uncertainty~~Patients inmust ~~some~~pay ~~countries,~~for ~~especially~~the ~~in emerging markets. For example~~procedure, ~~sales~~frequently inthrough ~~certain~~installment ~~Asian~~financing ~~and~~arrangements ~~developing~~with ~~markets~~third ~~may result in lower margins and higher exposure to intellectual property infringement or counterfeits~~parties. ~~Given~~They ~~the~~can ~~size~~defer of the ~~Company’s~~choice ~~business in China relative~~ to ~~its~~have ~~net~~refractive ~~sales~~surgery inif ~~the~~they ~~rest~~lack of the ~~world,~~disposable ~~macroeconomic~~income ~~conditions~~to inpay ~~China~~for ~~have~~it aor ~~significant~~do ~~impact~~not onfeel ~~the~~their ~~Company’s~~income ~~business,~~is ~~operations, and financial results~~secure. ~~Our~~Economic ~~results in fiscal 2024 were negatively impacted by a significant decline in ICL sales in China in the fourth quarter ended December 27~~stagnation, ~~2024,~~lack ~~where~~of ~~the sluggish economy and weak~~ consumer ~~consumption~~confidence ~~contributed~~or ~~to fluctuating demand for ICL procedures. If China experiences~~ a ~~significant~~recession orin ~~prolonged~~any ~~slowdown~~of orour ~~disruption~~larger tomarkets ~~its economy,~~ or ~~social~~on ~~or political unrest, we may experience a significant reduction in sales in the future.~~

Further, trade disputes or tensions between the United States and its significant trading partners may adversely affect our sales, including as a result of the imposition of tariffs or other barriers or restrictions on trade, or increase our costs. The institution of trade tariffs both globally and between the U.S. and China specifically could negatively impact the overall economic condition in our markets, including China, which could have a negative effect on our sales. As an example, on February 1, 2025, the U.S. government announced a 25% tariff on product imports from certain countries, including Mexico and Canada, and 10% tariffs on product imports from certain countries, including China. In response, China announced that they would impose counter tariffs of 10% to 15% on select goods imported from the U.S. If maintained, the newly announced tariffs and the potential escalation of trade disputes could pose a significant risk to our business and would affect our revenue and cost of goods sold. The extent, focus and duration of any such tariffs and the resulting impact on general economic conditions and on our business are uncertain and depend on various factors, such as negotiations between the U.S. and affected countries, the responses of other countries or regions, exemptions or exclusions that may be granted, availability and cost of alternative sources of supply, and demand for our products in affected markets. Further, actions we take to adapt to new tariffs or trade restrictions may cause us to modify our operations or forgo business opportunities. 19

19a global basis could slow ICL sales growth or, if severe, cause declines in sales, which could materially harm our business.

InWe ~~addition,~~believe ~~new~~that ~~laws~~negative orpublicity ~~regulations~~ in ~~China~~the orpast ~~elsewhere~~regarding ~~applicable~~the topotential ~~foreign~~complications ~~medical~~of ~~device~~refractive ~~companies~~surgery ~~could~~and ~~negatively~~potential ~~impact~~patient ~~our business. Also~~dissatisfaction, ~~we are exposed to credit and collectability risk on our trade receivables with customers~~ in ~~certain~~particular ~~international~~because ~~markets.~~of ~~There~~LASIK ~~can be no assurance we can effectively limit our credit risk~~ and ~~avoid~~other ~~losses~~corneal ~~and~~laser-based ~~our~~procedures, ~~ability~~decreased topatient ~~transfer~~interest ~~foreign earnings to the U.S. may be subject to taxes or restricted or result~~ in ~~incurring~~LASIK ~~substantial~~as ~~costs.~~well ~~Our continued success~~ as aall ~~global~~other ~~company~~refractive ~~depends,~~procedures. inDepending ~~part,~~ on ~~our~~the ~~ability~~nature ~~to develop~~ and ~~implement~~severity ~~policies~~of ~~and~~any ~~strategies~~future ~~that~~negative ~~are~~publicity ~~effective~~about inrefractive ~~anticipating~~surgery, ~~and managing these and other risks in~~ the ~~countries~~growth ~~where~~of weICL dosales ~~business.~~could ~~These~~be ~~and~~limited ~~other~~or ~~risks~~could ~~may~~decline ~~have~~due ato ~~material~~decreased ~~adverse~~patient ~~effect~~interest ~~on our operations~~ in ~~any~~all ~~particular~~refractive ~~country~~surgery, ~~and~~including on our ~~business, financial condition and results of operations as a whole~~ICL.

~~Changes~~Disruptions in our ~~effective~~supply ~~tax~~chain ~~rate~~ or ~~additional~~failure ~~tax~~to ~~liabilities~~adequately forecast product demand could ~~adversely~~result ~~impact~~in ~~our~~significant ~~net~~delays ~~income~~or lost sales.

WeThe ~~are~~loss ~~subject~~of toa ~~income~~material ~~taxes~~supplier ascould ~~well~~significantly asdisrupt ~~non-income-based~~our ~~taxes in Switzerland, the U~~business.S. ~~and~~In ~~various~~some ~~other~~cases, ~~jurisdictions in which~~ we ~~operate.~~obtain ~~The~~components ~~laws~~used ~~and~~in ~~regulations~~certain inof ~~these~~our ~~jurisdictions~~products ~~are~~from ~~inherently~~single ~~complex~~sources. ~~and~~If we ~~will~~experience bedifficulties ~~obliged~~acquiring tosufficient ~~make~~quantities ~~judgments and interpretations about the application~~ of ~~these~~required ~~laws~~materials ~~and~~or ~~regulations~~products tofrom ~~us, including~~ our ~~subsidiaries~~existing ~~and our operations and businesses. Those laws and regulations include those related to any restructuring of intercompany operations~~suppliers, ~~holdings~~ or ~~financings,~~if ~~the~~our ~~valuation~~suppliers ofare ~~intercompany~~found ~~services;~~to ~~cross~~be non-~~border~~compliant ~~payments~~with ~~between affiliated companies; and~~ the ~~related~~U.S. ~~effects~~FDA’s ~~on income tax~~QSR, ~~VAT~~other ~~and~~applicable ~~transfer tax. Further~~laws, ~~our~~or ~~tax~~STAAR’s ~~liabilities could be adversely affected by numerous other factors~~requirements, ~~including~~then ~~income~~qualifying ~~before taxes being lower than anticipated in countries with lower statutory tax rates~~ and ~~higher~~obtaining ~~than anticipated in countries with higher statutory tax rates, changes in~~ the ~~valuation~~required ofregulatory ~~deferred~~approvals ~~income~~to ~~tax~~use ~~assets~~alternative ~~and~~suppliers ~~liabilities,~~may ~~and~~be ~~changes~~a inlengthy ~~tax laws~~ and ~~regulations.~~uncertain ~~Although~~process weduring ~~believe~~which ~~our~~production ~~tax~~could ~~estimates~~be ~~are~~delayed ~~reasonable, any changes in our judgments~~ and ~~interpretation~~we ~~of tax laws or any material differences as a result of any audits~~ could ~~result~~lose ~~in unfavorable tax adjustments that may have an adverse effect on our overall tax liability~~sales.

~~Changes~~Our sources of supply for raw materials may be threatened by shortages and other market forces, by natural disasters, climate impacts, or public health crises or other disruptive events, or by the supplier’s failure to maintain adequate quality or a recall initiated by the supplier. Even when substitute suppliers are available, the need to verify the substitute supplier’s regulatory compliance and the quality standards of the replacement material could significantly delay production and materially reduce our sales. In particular, we manufacture the proprietary collagen-containing raw material used in ~~tax~~our ~~laws~~ICLs. If the supply of these collagen-containing raw materials is disrupted, it could result in ~~additional~~our ~~tax~~inability ~~liabilities~~to manufacture our ICL products and would have a material adverse effect on STAAR.

~~Changes~~While inour ~~tax~~net ~~laws~~sales ~~can~~decreased ~~and do occur. For example,~~ in ~~2017,~~fiscal ~~the~~2025 ~~U.S.~~compared ~~government~~to ~~enacted~~fiscal ~~the Tax Cuts and Jobs Act~~2024, ~~which~~we isintend ~~complex and continues~~ to bereturn ~~further clarified with supplemental guidance. Changes~~ to ~~tax~~sales ~~laws may require us to make significant judgment in determining the appropriate provision and related accruals for these taxes. Thus~~growth, ~~as a result, such changes could result in substantially higher taxes~~ and awe ~~significant~~will ~~adverse~~be ~~effect~~dependent on our ~~results~~suppliers ofto ~~operations,~~help ~~financial~~support ~~conditions~~such ~~and liquidity~~growth. InAny ~~addition,~~failure ~~the Organization for Economic Co-operation and Development (OECD), has published proposals covering a number of issues, including country-~~by~~-country~~ ~~reporting,~~us ~~permanent~~to ~~establishment~~forecast ~~rules,~~demand ~~transfer~~for ~~pricing~~or ~~rules,~~to ~~tax~~maintain ~~treaties~~an ~~and~~adequate ~~taxation~~supply of ~~the digital economy. On October 8~~, ~~2021,~~raw ~~the~~material ~~OECD/G20 inclusive framework on Base Erosion~~ and ~~Profit~~finished ~~Shifting~~product ~~(the~~could ~~Inclusive~~result ~~Framework)~~in ~~published~~an ainterruption ~~statement~~in ~~updating and finalizing~~ the ~~key~~supply ~~components~~ of acertain ~~two-pillar plan on global tax reform originally agreed on July 1~~products, ~~2021,~~which ~~and~~could aimpact ~~timetable~~sales ~~for~~of ~~implementation~~that ~~by 2023~~product. ~~The~~If ~~timetable~~our ~~for~~suppliers ~~implementation~~or ~~has~~we ~~since~~are ~~been~~unable ~~extended~~or toour ~~2024~~suppliers ~~and,~~are ~~with~~unwilling ~~respect~~ to ~~certain~~meet ~~components~~our ofincreased ~~the~~manufacturing ~~plan~~requirements, towe ~~2025.~~may ~~Under~~not ~~pillar one, a portion of the residual profits of multinational businesses with global turnover above €20 billion and a profit margin above 10% will~~ be ~~allocated~~able to ~~market~~produce ~~jurisdictions~~enough ~~where~~materials ~~such~~or ~~allocated~~products ~~profits~~in ~~would be taxed. Under pillar two, the Inclusive Framework has agreed on~~ a ~~global~~timely ~~minimum corporate tax rate of 15% for companies with revenue above €750 million~~manner, ~~calculated~~which oncould a jurisdictional basis. On February 1, 2023, the U.S. Financial Accounting Standards Board indicated that they believe the minimum tax imposed under pillar two is an alternative minimum tax, and, accordingly, deferred tax assets and liabilities associated with the minimum tax would not be recognized or adjusted for the estimated future effects of the minimum tax but would be recognized in the period incurred. The detail of the proposals is subject to change and the impact toour ~~us will need to be determined by reference to the final rules~~sales.

WeBecause ~~are~~our ~~vulnerable~~business is global, our sales and profits may fluctuate or decline in response to ~~any~~changes ~~loss~~in offoreign ~~use~~currency ofexchange ~~our~~rates ~~principal~~and/or ~~manufacturing~~other ~~facility~~international risks, including tariffs.

WeActivities ~~currently~~outside ~~manufacture~~the ~~all~~U.S. accounted for approximately 91% of our ~~ICL~~total ~~products~~sales atduring a2025. ~~single~~Foreign ~~facility~~currency fluctuations could result in ~~Monrovia,~~volatility ~~California~~of our revenue. IfThe ~~our~~results ~~manufacturing~~of ~~facility~~operations ~~suffered~~and athe ~~disruption,~~financial ~~shutdown~~position orof ~~catastrophic~~our ~~loss~~Japanese ~~due~~subsidiary toare ~~fire,~~reported ~~flood,~~in ~~earthquake,~~Japanese ~~terrorism~~yen orand ~~other~~then ~~natural~~translated orinto ~~man-made~~U.S. ~~disasters,~~dollars ~~including~~at ~~manufacturing~~the ~~challenges~~applicable ~~such~~exchange asrates ~~equipment~~for orinclusion ITin ~~failure~~our consolidated financial statements, itexposing ~~could~~us ~~have~~to atranslation ~~material~~risk. ~~adverse~~In ~~effect~~addition, onwe ~~our~~are ~~operations.~~exposed ~~Our~~to ~~manufacturing~~transaction ~~facility~~risk ~~has~~because ~~been,~~we incur some of our sales and ~~may~~expenses in currencies other than the ~~future~~U.S. ~~be,~~dollar. ~~adversely~~Our ~~impacted~~most bysignificant ~~weather~~currency exposures are to the Japanese yen, the euro, and ~~fire~~the ~~events~~Swiss franc, and itthe isexchange ~~located~~rates inbetween athese ~~region~~currencies ~~where~~and ~~earthquakes~~the ~~could~~U.S. ~~cause~~dollar ~~catastrophic~~may ~~loss~~fluctuate substantially. ~~Developing~~We ~~additional~~do ~~manufacturing~~not ~~sites~~actively ~~may~~hedge ~~require~~our ~~significant~~exposure ~~expense~~to ~~for~~currency ~~personnel~~rate ~~and~~fluctuations. ~~equipment~~Any ~~and~~strengthening aof ~~long~~the ~~period~~U.S. todollar ~~obtain~~would ~~regulatory~~likely ~~approvals~~negatively impact our results. We ~~are~~price some of our products in ~~the~~U.S. ~~process~~dollars, ofand ~~expanding~~thus ~~our~~changes ~~manufacturing~~in ~~capabilities~~exchange ~~for~~rates ~~STAAR’s~~can ~~ICL~~make our products more expensive in ~~our~~some ~~Nidau,~~offshore ~~Switzerland~~markets ~~facility~~and reduce our sales. ~~This~~Inflation iscould aalso ~~complex~~make ~~process~~our ~~that~~products ismore ~~subject~~expensive toand ~~numerous~~increase the credit risks ~~and~~to ~~uncertainties,~~which ~~and~~we ~~there~~are ~~can~~exposed. beFuture noforeign ~~guarantee~~currency ~~that~~fluctuations ~~this~~could ~~facility~~favorably ~~will~~or beunfavorably ~~prepared~~impact and ~~approved~~increase bythe ~~regulators~~volatility ~~for~~of ~~manufacturing~~our revenue, profitability, and stock price.

InEconomic, ~~our~~social, ~~major~~and ~~markets~~political conditions, ~~regulatory~~laws, ~~approval~~practices, toand ~~manufacture~~local ~~materials~~customs ~~and~~vary widely among the countries in which we sell our products. isOur ~~generally~~operations ~~limited~~outside toof the ~~current~~U.S. ~~manufacturing~~face ~~site~~a number of risks and potential costs, including, enjoying less stringent protection of intellectual property, and ~~changing~~facing economic, political, and social uncertainty in some countries, especially in emerging markets. For example, sales in certain Asian and developing markets may result in lower margins and higher exposure to intellectual property infringement or counterfeits. Given the ~~site~~size ~~requires~~of ~~applications~~the Company’s business in China relative to its net sales in the rest of the world, macroeconomic conditions in China have a significant impact on the Company’s business, operations, and ~~approval~~financial ~~from~~results. ~~regulatory~~Our ~~bodies~~results in fiscal 2024 were negatively impacted by a significant decline in ICL sales in China in the fourth quarter ended December 27, 2024, where the sluggish economy and weak consumer consumption contributed to fluctuating demand for ICL procedures. As expected, our sales in China declined in 2025, due to elevated levels of inventory held at our China distributors at

~~prior~~the toend ~~commercialization.~~of ToDecember ~~satisfy our own quality standards as well as regulations~~27, we2024. ~~must~~If ~~follow~~China ~~strict~~experiences ~~protocols~~a tosignificant ~~confirm~~or ~~that~~prolonged ~~products~~slowdown ~~and~~or ~~materials~~disruption ~~made at a new site are equivalent~~ to ~~those~~its ~~made at the currently approved site. Even minor changes in equipment~~economy, ~~supplies~~ or ~~processes~~social ~~require~~or ~~validation.~~political ~~Unanticipated~~unrest, ~~delays~~we ~~with~~may experience a ~~transferred~~significant ~~process~~reduction ~~or difficulties~~ in ~~manufacturing~~sales ~~a transferred material could interrupt our supply of products. Any sustained interruption~~ in ~~supply~~the ~~could cause us to lose market share and harm our business, financial condition and results of operations~~future.

IfFurther, ~~any~~trade disputes or tensions between the United States and its significant trading partners may adversely affect our sales, including as a ~~portion~~result of ~~our~~the ~~facilities~~imposition ~~were~~of totariffs ~~experience~~or aother ~~catastrophic~~barriers ~~loss~~or restrictions on trade, or ifincrease ~~one~~our costs. The institution of ~~our~~trade ~~facilities~~tariffs isboth ~~found~~globally ~~not~~and tobetween bethe U.S. and China specifically could negatively impact the overall economic condition in ~~compliance~~our ~~with~~markets, ~~regulatory~~including ~~requirements~~China, itwhich could ~~disrupt~~have a negative effect on our ~~operations~~sales. As an example, ~~delay~~on ~~production~~February ~~and~~1, ~~shipments~~2025, ~~delay~~the orU.S. ~~reduce~~government ~~sales~~announced a 25% tariff on product imports from certain countries, including Mexico and ~~revenue~~Canada, and ~~result~~10% intariffs ~~large~~on ~~expenses~~product toimports ~~repair~~from orcertain ~~replace~~countries, including China. In response, China announced that they would impose counter tariffs on select goods imported from the ~~facility~~U.S., asto ~~well~~which asthe ~~lost~~U.S. ~~customers~~responded orwith ~~sales~~heightened reciprocal tariffs. ~~Our~~The ~~insurance~~U.S. ~~for~~and ~~property~~China ~~damage~~have reached a one-year agreement with an expiration of November 10, 2026, which includes the continued suspension of the heightened reciprocal tariffs on China and delayed enforcement of new U.S. export rules targeting affiliates of blacklisted firms. If maintained, the newly announced tariffs and the potential escalation of trade disputes could pose a significant risk to our business ~~interruption~~and ~~may~~would ~~not~~affect ~~cover~~our revenue and cost of goods sold. The extent, focus and duration of any ~~particular~~such ~~loss~~tariffs and the resulting impact on general economic conditions and on our business are uncertain and depend on various factors, orsuch as negotiations between the U.S. and affected countries, ifthe ~~covered~~responses of other countries or regions, exemptions or exclusions that may be ~~sufficient.~~granted, Weavailability doand ~~not~~cost ~~carry~~of ~~insurance~~alternative orsources ~~reserve~~of ~~funds~~supply, and demand for ~~interruptions~~our products in affected markets. Further, actions we take to adapt to new tariffs or ~~potential~~trade ~~losses~~restrictions ~~arising~~may ~~from~~cause ~~earthquakes~~us to modify our operations or ~~terrorism~~forgo business opportunities.

~~Public~~In ~~health crises~~addition, ~~political~~new ~~crises~~laws, regulations and ~~other~~policies ~~catastrophic~~in ~~events~~China or ~~other~~elsewhere ~~events~~applicable ~~outside~~to offoreign medical device companies could negatively impact our business. The medical device landscape in China is rapidly evolving, and local preference policies and cost control measures, including programs like volume-based procurement, have the potential to disrupt our business. Also, we are exposed to credit and collectability risk on our trade receivables with customers in certain international markets. There can be no assurance we can effectively limit our credit risk and avoid losses and our ability to transfer foreign earnings to the U.S. may ~~impact~~be subject to taxes or restricted or result in incurring substantial costs. Our continued success as a global company depends, in part, on our ability to develop and implement policies and strategies that are effective in anticipating and managing these and other risks in the countries where we do business. These and other risks may have a material adverse effect on our operations in any particular country and on our business, financial condition and results of operations as a whole.

InChanges ~~2024,~~in ~~we generated approximately 94% of~~ our ~~total~~effective ~~sales~~tax ~~outside~~rate ~~the U.S. A natural disaster (such as a climate-related event~~ or ~~otherwise),~~additional ~~public~~tax ~~health~~liabilities crisis (such as a pandemic or epidemic), political crisis (such as terrorism, war, political instability or other conflict), or other events outside of our control that may occur anywhere around the world, may adversely impact our business and operating results. Moreover, these types of events could ~~negatively impact surgeon or patient spending in the impacted region(s) or depending upon the severity, globally, which could~~ adversely impact our ~~operating~~net ~~results~~income.

~~The~~We ~~extent~~are subject to ~~which~~income ataxes ~~pandemic,~~as ~~public~~well ~~health~~as ornon-income-based ~~political~~taxes ~~crisis~~ in Switzerland, the ~~future~~U.S. ~~impacts~~and ~~our~~various ~~business,~~other ~~operations,~~jurisdictions ~~and~~in ~~financial~~which ~~results,~~we ~~including~~operate. ~~the~~The ~~duration~~laws and ~~magnitude~~regulations ofin ~~such~~these ~~effects,~~jurisdictions ~~will depend on numerous evolving factors that~~ are ~~uncertain~~inherently complex and ~~cannot~~we will be ~~predicted,~~obliged ~~including~~to ~~the~~make ~~following:~~judgments ~~the duration~~ and ~~scope~~interpretations ofabout the ~~pandemic,~~application ~~public~~of ~~health~~these orlaws ~~political~~and ~~crisis;~~regulations ~~the~~to ~~impact~~us, itincluding ~~has~~our onsubsidiaries ~~global~~ and ~~regional~~our ~~economies~~operations and ~~economic~~businesses. ~~activity,~~Those ~~including~~laws ~~the duration~~ and ~~magnitude~~regulations ofinclude ~~its~~those ~~impact~~related onto ~~consumer~~any ~~spending;~~restructuring ~~how~~of ~~quickly~~intercompany ~~and~~operations, toholdings ~~what~~or ~~extent~~financings, ~~more~~the ~~customary~~valuation ~~economic~~of ~~and~~intercompany ~~operating conditions can resume~~services; ~~its~~cross-border ~~impact~~payments onbetween ~~our~~affiliated ~~customers’ facilities~~companies; ~~levels~~and ofthe ~~consumer~~related ~~confidence;~~effects ~~whether~~on ~~our~~income ~~preventative~~tax, ~~measures~~VAT ~~such~~and astransfer ~~remote~~tax. ~~working arrangements~~Further, ~~changes~~our totax ~~manufacturing~~liabilities ~~work~~could ~~areas,~~be ~~such~~adversely asaffected ~~adherence~~by tonumerous ~~social~~other ~~distancing guidelines~~factors, ~~and~~including ~~other~~income ~~workforce~~before ~~changes~~taxes ~~will~~being ~~impact~~lower ~~operational~~than ~~efficiency~~anticipated orin ~~inventory~~countries ~~levels;~~with ~~our~~lower ~~ability~~statutory totax ~~obtain~~rates ~~supplies~~and ~~from~~higher ~~vendors~~than oranticipated ~~transport~~in ~~products~~countries towith ~~customers;~~higher orstatutory ~~adverse~~tax ~~impacts~~rates, tochanges ~~any~~in ~~other~~the ~~element~~valuation of ~~our~~deferred ~~supply~~income ~~chain;~~tax ~~the~~assets ~~impact~~and onliabilities, ~~regulatory~~and ~~agencies,~~changes ~~including~~in ~~the~~tax ~~review~~laws and ~~approval~~regulations. ~~process;~~Although ~~the~~we ~~impact~~believe onour ~~clinical~~tax ~~studies;~~estimates ~~the~~are ~~ability~~reasonable, ofany ~~our~~changes ~~customers~~in toour ~~successfully~~judgments ~~navigate~~and ~~the~~interpretation ~~impacts~~ of ~~the~~tax ~~pandemic,~~laws ~~public health~~ or ~~political~~any ~~crisis,~~material ~~such~~differences as ~~resuming~~a ~~activities~~result ~~and~~of ~~growing~~any ~~patient~~audits ~~interest~~could result in ~~our~~unfavorable ~~lenses;~~tax ~~and~~adjustments ~~actions~~that ~~governments,~~may ~~businesses~~have ~~and~~an ~~individuals~~adverse ~~take~~effect inon ~~response~~our tooverall ~~the~~tax ~~pandemic, public health or political crisis~~liability.

InChanges addition, a prolonged pandemic, public health or political crisis could adversely impact our ability to recruit and/or retain employees and the continued service and availability of skilled personnel necessary to run our complex production operations, as well as members of our management team, third-party suppliers, distributors and vendors. To the extent our management or other personnel are impacted in ~~significant~~tax ~~numbers~~laws ~~and are not available to perform their job duties (for example, for health and safety reasons), we~~ could ~~experience~~result ~~delays~~ in, oradditional ~~the~~tax ~~suspension of, our manufacturing operations, research and product development activities, regulatory work streams, and other important commercial and operational functions~~liabilities.

~~The~~Changes ~~loss~~in oftax ~~key~~laws ~~employees~~can and do occur. For example, orin ~~our~~2017, ~~inability~~the toU.S. ~~recruit~~government enacted the Tax Cuts and Jobs Act, ~~hire~~which is complex and ~~retain~~continues ~~skilled~~to be further clarified with supplemental guidance. Changes to tax laws may require us to make significant judgment in determining the appropriate provision and ~~experienced~~related ~~personnel~~accruals for these taxes. Thus, as a result, such changes could ~~negatively~~result ~~impact~~in substantially higher taxes and a significant adverse effect on our ~~ability~~results toof ~~effectively~~operations, ~~manage~~financial conditions and ~~expand~~liquidity. ~~our~~In ~~business~~addition, the Organization for Economic Co-operation and Development (OECD), has published proposals covering a number of issues, including country-by-country reporting, permanent establishment rules, transfer pricing rules, tax treaties and taxation of the digital economy. On October 8, 2021, the OECD/G20 inclusive framework on Base Erosion and Profit Shifting (the Inclusive Framework) published a statement updating and finalizing the key components of a two-pillar plan on global tax reform originally agreed on July 1, 2021, and a timetable for implementation by 2023. The timetable for implementation has since been extended to 2024 and, with respect to certain components of the plan, to 2025. Under pillar one, a portion of the residual profits

Our success depends on the skills, experience and performance of our senior management and other key employees. The loss or incapacity of existing members of our executive management team could negatively impact our operations, particularly if we experience difficulties in hiring qualified successors. Further, it could be particularly detrimental if any key employee or employees went to work for a competitor. Also, our future success depends on our ability to identify, attract, train, motivate and retain other highly skilled personnel. Failure to do so may adversely affect our results. We do not maintain insurance policies to cover the cost of replacing the services of any of our key employees who may unexpectedly die or become disabled.21

Weof ~~compete~~multinational businesses with ~~much~~global ~~larger~~turnover above €20 billion and a profit margin above 10% will be allocated to market jurisdictions where such allocated profits would be taxed. Under pillar two, the Inclusive Framework has agreed on a global minimum corporate tax rate of 15% for companies with revenue above €750 million, calculated on a jurisdictional basis. On February 1, 2023, the U.S. Financial Accounting Standards Board indicated that they believe the minimum tax imposed under pillar two is an alternative minimum tax, and, ~~low~~accordingly, deferred tax assets and liabilities associated with the minimum tax would not be recognized or adjusted for the estimated future effects of the minimum tax but would be recognized in the period incurred. On January 5, 2026, the OECD issued administrative guidance outlining a framework under which U.S.-~~cost~~parented ~~Asian~~groups ~~manufacturers~~may be excluded from the application of the OECD’s global minimum tax rules. Each member jurisdiction will need to adopt this guidance into local law, and the timing and manner of adoption may vary. We are continuing to monitor developments related to this guidance and will evaluate the impact on our financial statements as additional information becomes available.

We ~~believe~~are ~~our~~vulnerable ~~primary competition in selling the ICL~~ to ~~patients~~any ~~seeking~~loss ~~surgery~~of touse ~~correct~~of ~~refractive~~our ~~conditions~~principal ~~lies~~manufacturing ~~not in similar products to the ICL, but in laser surgical procedures~~facility. ~~Alcon (formerly a part of Novartis), Johnson~~

21Our principal ICL manufacturing facility is located in Monrovia, California. If our Monrovia manufacturing facility suffered a disruption, shutdown or catastrophic loss due to fire, flood, earthquake, terrorism or other natural or man-made disasters, including manufacturing challenges such as equipment or IT failure, it could have a material adverse effect on our operations. Our Monrovia manufacturing facility has been, and may in the future be, adversely impacted by weather and fire events, and it is located in a region where earthquakes could cause catastrophic loss. Developing additional manufacturing sites may require significant expense for personnel and equipment and a long period to obtain regulatory approvals. We are in the process of expanding our manufacturing capabilities for STAAR’s ICL products in our Nidau, Switzerland facility.

&While ~~Johnson~~we ~~(formerly~~have ~~Advanced~~received ~~Medical~~the ~~Optics~~required orregulatory ~~AMO),~~approvals ~~Bausch~~and ~~Health~~have ~~Companies~~started ~~(formerly~~manufacturing ~~Valeant,~~ICLs ~~Bausch~~at &our ~~Lomb~~Nidau ~~or B+L)~~facility, ~~and~~ramping ~~Carl~~up ~~Zeiss~~production ~~Meditec~~is ~~AG,~~subject ~~all~~to ~~market~~numerous ~~lasers~~risks ~~for corneal refractive surgery~~ and ~~promote~~uncertainties. ~~their~~To ~~sales~~satisfy ~~worldwide.~~our ~~Each~~own ofquality ~~these~~standards ~~companies~~as ~~has~~well ~~much~~as ~~greater financial~~regulations, ~~technical, marketing and distribution resources and brand name recognition than~~ we ~~do,~~must ~~and~~follow ~~some~~strict ofprotocols ~~them~~to ~~have~~confirm ~~large~~that ~~international markets for a full suite of ophthalmic~~ products. ~~Their~~and ~~greater~~materials ~~resources~~made ~~for~~at ~~research,~~the ~~development~~Nidau ~~and marketing~~facility, and ~~their~~any ~~greater~~new ~~capacity~~facility toin ~~offer~~the ~~comprehensive~~future, ~~products~~are ~~and~~equivalent ~~equipment~~ to ~~providers,~~those ~~makes~~made ~~for~~at ~~intense~~our ~~competition~~Monrovia facility. WeEven ~~also~~minor ~~face~~changes ~~competition~~in ~~from other phakic implantable lenses~~equipment, ~~including~~supplies ~~lenses~~or ~~made~~processes byrequire ~~Biotech~~validation. ~~Vision~~Unanticipated ~~Care,~~delays ~~Care~~with ~~Group,~~a ~~Eyebright,~~transferred ~~and~~process ~~Ophtec.~~or ~~Increasingly,~~difficulties ~~competitors~~in ~~from~~manufacturing ~~Asia~~a ~~are~~transferred ~~beginning~~material tocould ~~appear~~interrupt inour ~~some~~supply ~~markets~~of ~~with~~products. ~~their~~Any ~~low-cost~~sustained ~~version~~interruption ofin ansupply ~~implantable~~could ~~contact~~cause ~~lens,~~us ~~which~~to ~~competes~~lose ~~with~~market ~~our~~share ~~ICL.~~and ~~With~~harm our ~~commercial success with the ICL~~business, ~~additional~~financial ~~companies~~condition ~~may~~and ~~seek~~results toof ~~enter the refractive phakic intraocular lens market~~operations.

WeIf ~~could~~any or a portion of our facilities were to experience ~~losses~~a ~~due~~catastrophic loss, or if one of our facilities is found not to ~~product~~be ~~liability~~in ~~claims~~compliance with regulatory requirements, it could disrupt our operations, delay production and shipments, delay or reduce sales and revenue and result in large expenses to repair or replace the facility, as well as lost customers or sales. Our insurance for property damage and business interruption may not cover any particular loss, or, if covered, be sufficient. We do not carry insurance or reserve funds for interruptions or potential losses arising from earthquakes or terrorism.

WePublic ~~have~~health ~~been subject to product liability claims in the past and may experience such claims in the future. Product liability claims against us may not be covered~~crises, ~~may~~political exceed the coverage limits of our insurance policies or cause us to record a loss in excess of our deductible. A product liability claim that exceeds our insurance coverage could materially harm our businesscrises, ~~financial condition,~~ and ~~results~~other ofcatastrophic ~~operations.~~events ~~Even if an insurance policy covers a product liability loss, we must generally pay for losses until they reach the level of the policy’s stated deductible~~ or ~~retention~~other ~~amount~~events ~~after~~outside ~~which the insurer begins paying. The payment~~ of ~~retentions~~our orcontrol ~~deductibles~~may ~~for~~impact ~~a significant number of claims could have a material adverse effect on~~ our business~~, financial condition, and results of operations~~.

~~Any~~In ~~product~~2025, ~~liability~~we ~~claim~~generated ~~would~~approximately ~~divert~~91% ~~managerial~~of ~~and~~our ~~financial~~total ~~resources~~sales ~~and~~outside ~~could~~the ~~harm~~U.S. A natural disaster (such as a climate-related event or otherwise), public health crisis (such as a pandemic or epidemic), political crisis (such as terrorism, war, political instability or other conflict), or other events outside of our ~~reputation~~control ~~with~~that ~~customers~~may occur anywhere around the world, may adversely impact our business and operating results. WeMoreover, ~~cannot~~these ~~assure~~types ~~investors~~of ~~that~~events wecould ~~will~~negatively ~~not~~impact ~~have~~surgeon ~~product~~or ~~liability~~patient ~~claims~~spending in the ~~future~~impacted region(s) or ~~that~~depending ~~such~~upon ~~claims~~the ~~would~~severity, ~~not~~globally, ~~have~~which acould ~~material~~adversely ~~adverse~~impact ~~effect on~~ our ~~business~~operating results.

~~Our~~The ~~defined~~extent ~~benefit~~to ~~pension~~which ~~plans~~a ~~are~~pandemic, ~~currently~~public ~~underfunded~~health or political crisis in the future impacts our business, operations, and wefinancial ~~may~~results, including the duration and magnitude of such effects, will depend on numerous evolving factors that are uncertain and cannot be ~~subject~~predicted, including the following: the duration and scope of the pandemic, public health or political crisis; the impact it has on global and regional economies and economic activity, including the duration and magnitude of its impact on consumer spending; how quickly and to ~~significant~~what ~~increases~~extent more customary economic and operating conditions can resume; its impact on our customers’ facilities; levels of consumer confidence; whether our preventative measures such as remote working arrangements, changes to manufacturing work areas, such as adherence to social distancing guidelines, and other workforce changes will impact operational efficiency or inventory levels; our ability to obtain supplies from vendors or transport products to customers; or adverse impacts to any other element of our supply chain; the impact on regulatory agencies, including the review and approval process; the impact on clinical studies; the ability of our customers to successfully navigate the impacts of the pandemic, public health or political crisis, such as resuming activities and growing patient interest in ~~pension~~our ~~benefit~~lenses; ~~obligations~~and ~~under~~actions ~~those~~governments, ~~pension~~businesses ~~plans~~and individuals take in response to the pandemic, public health or political crisis.

We sponsor two defined benefit pension plans through our wholly owned Swiss and Japanese subsidiaries, which we refer to as the “Swiss Plan” and the “Japan Plan”, respectively. Both plans are underfunded and may require significant cash payments. We determine our pension benefit obligations and funding status using many assumptions. If the investment performance does not meet our expectations, or if other actuarial assumptions are modified, or not realized, we may be required to contribute more than we currently expect and increase our future pension benefit obligations to be funded from our operations. Our pension plans taken together are underfunded by approximately $6.7 million ($0.4 million for the Japan Plan and $6.3 million for the Swiss Plan) as of December 27, 2024. If our cash flow from operations is insufficient to fund our worldwide pension obligations, as well as other cash requirements, we may have to seek additional capital.22

~~Our~~In ~~activities~~addition, ~~involve~~a ~~hazardous~~prolonged ~~materials~~pandemic, ~~emissions,~~public health or political crisis could adversely impact our ability to recruit and/or ~~use~~retain employees and the continued service and availability of anskilled ~~irradiator~~personnel necessary to run our complex production operations, as well as members of our management team, third-party suppliers, distributors and ~~may~~vendors. ~~subject~~To usthe extent our management or other personnel are impacted in significant numbers and are not available to ~~environmental~~perform ~~liability~~their job duties (for example, for health and safety reasons), we could experience delays in, or the suspension of, our manufacturing operations, research and product development activities, regulatory work streams, and other important commercial and operational functions.

~~Our~~The ~~manufacturing,~~loss ~~research and development activities involve the use~~ of ~~hazardous~~key ~~materials and equipment and use of an irradiator. Federal~~employees, ~~state~~or ~~and~~our ~~local~~inability ~~laws~~to ~~and regulations govern the use~~recruit, ~~manufacturing,~~hire ~~storage, handling~~ and ~~disposal~~retain ofskilled ~~these materials~~ and ~~certain~~experienced waste products in the places where we have operations. We cannot eliminate the risk of accidental contamination or injury from these materials and equipment. Remedial environmental actions could require us to incur substantial unexpected costspersonnel, ~~which~~ could ~~materially~~negatively ~~and~~impact ~~adversely affect~~ our ~~financial~~ability ~~condition and results of operations. If we were involved in an environmental accident or found~~ to beeffectively inmanage ~~substantial~~and ~~non-compliance~~expand ~~with applicable environmental laws, it could harm~~ our ~~reputation, and we could be held liable for damages or penalized with fines~~business.

~~Data~~Our ~~corruption~~success depends on the skills, ~~cyber-based~~experience ~~attacks~~and orperformance ~~network~~of ~~security~~our ~~breaches~~senior management and/ other key employees. The loss or ~~noncompliance~~incapacity ~~with~~of ~~data~~existing ~~protection~~members ~~and~~of ~~privacy~~our ~~regulations~~executive management team could negatively impact our operations, particularly if we experience difficulties in hiring qualified successors. In 2025, we announced a number of leadership changes, including the appointment of a new Chief Executive Officer and new Chief Financial Officer. In 2026, in accordance with the Cooperation Agreement, our Chief Executive Officer agreed to step down, and the Board appointed interim Co-Chief Executive Officers. We are currently conducting a search for a permanent Chief Executive Officer. Such changes, and any changes in the future, can be disruptive to the business. In addition, it could be particularly detrimental if any key employee or employees went to work for a competitor. Also, our future success depends on our ability to identify, attract, train, motivate and retain other highly skilled personnel. Failure to do so may adversely affect our results. We do not maintain insurance policies to cover the cost of replacing the services of any of our key employees who may unexpectedly die or become disabled.

We ~~depend~~compete onwith ~~information~~much ~~technology~~larger ~~networks~~companies and ~~our~~low-cost ~~information~~Asian ~~technology infrastructure for electronic communications among our locations around the world and between our personnel and our subsidiaries, customers, and suppliers~~manufacturers. The integrity and protection of our customer, vendor, supplier, employee, and other Company data that we collect, use and store, including personal information, is an important part of our business. Addressing applicable and evolving security and privacy regulations may increase our operating costs or adversely affect our business operations.

~~Certain~~We ofbelieve our ~~employees,~~primary ~~contractors~~competition ~~and~~in ~~vendors~~selling ~~have~~the ~~access~~ICL to ~~and~~patients ~~use~~seeking ~~personal~~surgery ~~information~~to correct refractive conditions lies not in similar products to the ~~ordinary~~ICL, ~~course~~but in laser surgical procedures. Alcon (formerly a part of ~~our~~Novartis), ~~business~~Johnson & Johnson (formerly Advanced Medical Optics or AMO), Bausch Health Companies (formerly Valeant, Bausch & Lomb or B+L), and Carl Zeiss Meditec AG, all market lasers for corneal refractive surgery and promote their sales worldwide. ~~The~~Each ~~secure~~of ~~processing~~these companies has much greater financial, ~~maintenance~~technical, marketing and ~~transmission~~distribution resources and brand name recognition than we do, and some of ~~this~~them ~~information~~have islarge ~~critical~~international markets for a full suite of ophthalmic products. Their greater resources for research, development and marketing, and their greater capacity to offer comprehensive products and equipment to providers, makes for intense competition. We also face competition from other phakic implantable lenses, including lenses made by Biotech Vision Care, Care Group, Eyebright, and Ophtec. Increasingly, competitors from Asia are beginning to appear in some markets with their low-cost version of an implantable contact lens, which competes with our ICL. With our commercial success with the ICL, additional companies may seek to enter the refractive phakic intraocular lens market.

22We could experience losses due to product liability claims.

~~operations.~~We ~~Despite~~have ~~our~~been ~~security~~subject ~~measures~~to ~~and~~product ~~business~~liability ~~controls,~~claims ~~our~~in ~~information~~the ~~technology~~past and ~~infrastructure~~ may beexperience ~~vulnerable~~such toclaims ~~attacks~~in bythe ~~hackers,~~future. ~~breaches~~Product ~~due~~liability toclaims ~~employee,~~against ~~contractor~~us ormay ~~vendor~~not ~~error,~~be ~~or malfeasance~~covered, ~~systems~~may ~~error~~exceed ~~(whether~~the ascoverage alimits ~~result~~ of anour ~~intentional~~insurance ~~breach,~~policies ~~a natural disaster~~ or ~~human~~cause ~~error)~~us ~~or other disruptions or subject~~ to ~~the~~record ~~inadvertent~~a orloss ~~intentional~~in ~~unauthorized~~excess ~~release~~ of ~~information. Any such occurrence could compromise~~ our ~~networks and the information stored thereon could be accessed, publicly disclosed, lost or stolen~~deductible. ~~Any~~A ~~such~~product ~~access,~~liability ~~disclosure~~claim orthat ~~other~~exceeds ~~loss~~our ofinsurance ~~information~~coverage could ~~result~~materially inharm ~~legal~~our ~~claims~~business, orfinancial ~~proceedings~~condition, and ~~liability~~results ~~under laws that protect the privacy~~ of ~~personal information and regulatory penalties, disrupt our~~ operations. ~~and~~Even ~~the~~if ~~supply~~an ofinsurance ~~products~~policy wecovers ~~provide~~a toproduct ~~our~~liability ~~clients~~loss, ~~compromise~~we ~~our~~must ~~intellectual~~generally ~~property~~pay orfor ~~other~~losses ~~confidential~~until ~~business~~they ~~information,~~reach orthe ~~damage~~level ~~our reputation, any~~ of ~~which~~the ~~could~~policy’s ~~adversely~~stated ~~affect~~deductible ~~our~~or ~~profitability,~~retention ~~revenue~~amount ~~and~~after ~~competitive position. Many of our employees currently work remotely,~~ which ~~may~~the ~~make~~insurer usbegins ~~more vulnerable to cyberattacks~~paying. ~~While~~The wepayment ~~have~~of ~~not~~retentions ~~experienced a material system failure, accident~~ or ~~security~~deductibles ~~breach~~for toa ~~date, we cannot assure you that our data protection efforts and our investment in information technology will prevent~~ significant ~~breakdowns,~~number ~~data~~of ~~leakages,~~claims ~~breaches in our systems or other cyber incidents that~~ could have a material adverse effect ~~upon~~on our ~~reputation,~~ business, ~~operations or~~ financial condition~~. We continue to invest in our cybersecurity program to enhance current capabilities and also implement new capabilities in our effort to keep pace with the changing threat landscape. Also~~, ~~certain of our information technology systems are not redundant,~~ and ~~our disaster recovery planning is not sufficient for every eventuality. Despite any precautions we may take, such events could materially harm our reputation and financial~~ results. ~~Moreover, while we maintain cyber insurance, it may be insufficient to address any potential loss incurred. We also rely on third parties to host or otherwise process some~~ of ~~this data (such as cloud-based computing)~~operations. Elements of our information technology systems that we outsource to third parties may also be vulnerable to various types of attacks or disruptions. Any failure by a third party to prevent security breaches could have adverse consequences for us.

WeAny ~~are~~product ~~subject~~liability toclaim ~~various~~would ~~data~~divert ~~protection~~managerial and ~~privacy~~financial ~~regulations~~resources ~~in different jurisdictions, including the General Data Protection Regulation (Regulation (EU) 2016/679) (GDPR)~~ and ~~the~~could ~~California~~harm ~~Consumer~~our ~~Privacy~~reputation ~~Act~~with customers. We ~~have~~cannot ~~made~~assure ~~and~~investors ~~continue~~that towe ~~engage~~will innot ~~compliance~~have ~~efforts~~product toliability ~~satisfy~~claims ~~these and other regulations, however, we may be unsuccessful~~ in ~~complying~~the ~~with~~future ~~applicable requirements, and may be at risk of enforcement actions and/~~or ~~subject~~that tosuch ~~fines,~~claims ~~including~~would ~~those~~not ~~imposed~~have by a ~~data~~material ~~protection~~adverse ~~authority.~~effect Ason a result, we may incur substantial expense in complying with data protection and privacy regulations, exposure resulting from a data breach, ransomware or non-compliance and may be distracted from other aspects of our business.

~~The~~Our ~~increased~~defined ~~use~~benefit ofpension ~~social~~plans ~~media~~are ~~platforms~~currently underfunded and ~~mobile~~we ~~technologies~~may ~~presents~~be ~~additional~~subject ~~risks~~to ~~and~~significant ~~challenges~~increases in pension benefit obligations under those pension plans.

~~Social~~We ~~media~~sponsor ~~platforms~~two ~~and~~defined ~~mobile~~benefit ~~technologies~~pension ~~are~~plans ~~increasingly~~through ~~being~~our ~~used~~wholly toowned ~~communicate~~Swiss ~~about our products~~ and ~~the~~Japanese ~~health~~subsidiaries, ~~conditions~~which ~~they~~we ~~are~~refer ~~intended~~ to ~~treat.~~as ~~Their~~the ~~use~~“Swiss ~~poses~~Plan” ~~risks to our business~~ and ~~requires~~the ~~specific~~“Japan ~~attention~~Plan”, ~~and monitoring~~respectively. ~~For~~Both ~~example,~~plans ~~patients,~~are ~~surgeons,~~underfunded ~~competitors,~~and ~~or others~~ may ~~use~~require ~~these~~significant ~~channels~~cash topayments. ~~comment~~We ondetermine our ~~products,~~pension ~~including~~benefit ~~the~~obligations ~~safety or effectiveness of a product~~ and tofunding ~~report~~status anusing ~~alleged~~many ~~adverse event~~assumptions. ~~Negative~~If ~~posts~~the orinvestment ~~comments~~performance ~~about~~does usnot ormeet our ~~business~~expectations, onor ~~any~~if ~~social~~other ~~networking~~actuarial ~~web~~assumptions ~~site~~are ~~could~~modified, ~~harm~~or ~~our~~not ~~reputation. In addition~~realized, ~~our~~we ~~employees~~ may ~~use~~be ~~social~~required ~~media~~to ~~tools~~contribute ~~and~~more ~~mobile~~than ~~technologies~~we ~~inappropriately,~~currently ~~which~~expect ~~may~~and ~~give~~increase ~~rise~~our tofuture ~~liability,~~pension orbenefit ~~which~~obligations ~~could lead~~ to ~~the~~be ~~exposure~~funded offrom ~~sensitive~~our ~~information~~operations. InOur ~~either~~pension ~~case,~~plans ~~such~~taken ~~uses~~together ofare ~~social~~underfunded ~~media~~by ~~and mobile technologies could have a material adverse effect on our business, financial condition, and results of operations.~~approximately

~~Acquisitions of technologies, products, and businesses could disrupt our operations, involve increased expenses and present risks not contemplated at the time of the transactions.~~23

We ~~may~~$6.4 ~~consider~~million ~~and,~~($0.4 asmillion ~~appropriate,~~for ~~make~~the ~~acquisitions~~Japan ofPlan ~~technologies,~~and ~~products,~~$6.0 ~~and~~million ~~businesses~~for ~~that~~the weSwiss ~~believe~~Plan) ~~are~~as ~~complementary~~of toJanuary ~~our~~2, ~~business~~2026. ~~Acquisitions~~If ~~typically~~our ~~entail~~cash ~~many~~flow ~~risks~~from ~~and~~operations ~~could~~is ~~result~~insufficient into ~~difficulties~~fund inour ~~integrating~~worldwide ~~the~~pension ~~operations~~obligations, ~~personnel,~~as ~~technologies,~~well ~~and~~as ~~products~~other ~~acquired~~cash requirements, ~~and~~we ~~mitigating the risk of unknown liabilities some of which~~ may ~~result~~have into ~~significant~~seek ~~payments~~additional ~~or charges to earnings~~capital.

IfOur weactivities ~~are~~involve ~~unable~~hazardous ~~to successfully integrate our acquisitions with our existing business~~materials, ~~we may not obtain the advantages that the acquisitions were intended to create~~emissions, ~~which may materially adversely affect our business,~~ and ~~our~~use ~~ability~~of toan ~~develop~~irradiator and ~~introduce new products. Actual costs and sales synergies, if achieved at all,~~ may besubject ~~lower~~us ~~than we expect and may take longer~~ to ~~achieve~~environmental ~~than we anticipate~~liability. Acquisitions may also divert management’s attention from our core business. Furthermore, the products of companies we acquire may overlap with our products or those of our customers, creating conflicts with existing relationships or with other commitments that are detrimental to the integrated businesses.

23Our manufacturing, research and development activities involve the use of hazardous materials and equipment and use of an irradiator. Federal, state and local laws and regulations govern the use, manufacturing, storage, handling and disposal of these materials and certain waste products in the places where we have operations. We cannot eliminate the risk of accidental contamination or injury from these materials and equipment. Remedial environmental actions could require us to incur substantial unexpected costs, which could materially and adversely affect our financial condition and results of operations. If we were involved in an environmental accident or found to be in substantial non-compliance with applicable environmental laws, it could harm our reputation, and we could be held liable for damages or penalized with fines.

IfData wecorruption, ~~are~~cyber-based ~~not~~attacks ~~able~~or tonetwork ~~manage~~security ~~growth~~breaches ~~successfully,~~and/or itnoncompliance ~~could~~with ~~adversely~~data ~~affect~~protection ~~our~~and ~~business,~~privacy ~~financial~~regulations ~~condition,~~could ~~and~~negatively ~~results~~impact ofour operations.

~~While~~We ~~our~~depend ~~net~~on ~~sales~~information ~~decreased~~technology innetworks ~~fiscal~~and ~~2024 compared to fiscal 2023, we intend to return to sales growth. Growth can place a significant strain on~~ our ~~financial,~~information ~~operational,~~technology ~~and~~infrastructure ~~managerial~~for ~~resources.~~electronic Incommunications ~~order~~among ~~to support~~ our ~~growth,~~locations wearound ~~must~~the ~~continue~~world ~~to implement~~ and ~~enhance~~between our ~~managerial,~~personnel ~~operational~~ and ~~financial~~our ~~systems~~subsidiaries, ~~expand our operations~~customers, and ~~continue~~suppliers. toThe ~~recruit~~integrity and ~~train~~protection ~~qualified~~of ~~personnel. There can be no assurance that~~ our ~~strategic~~customer, ~~and~~vendor, ~~operational planning will allow us to adequately manage anticipated growth. Factors such as a failure to follow specific internal practices and procedures~~supplier, ~~equipment malfunction~~employee, ~~environmental~~and ~~factors~~other orCompany ~~damage~~data tothat ~~one~~we ~~or more of our facilities could adversely affect our ability to manufacture our products. For example~~collect, inuse ~~the~~and ~~second half of 2021~~store, asincluding wepersonal ~~increased production to meet increased demand~~information, weis ~~experienced~~an aimportant ~~decline~~part ~~in product yield. In the event~~ of aour ~~slower-than-planned manufacturing output, we may be unable to quickly meet customer demand~~business. InAddressing ~~the~~applicable ~~event~~and ofevolving asecurity ~~significant~~and ~~manufacturing~~privacy ~~challenge,~~regulations we may ~~experience~~increase ~~delays~~our inoperating ~~meeting~~costs ~~product~~or ~~demand which could~~ adversely affect our ~~results~~business of operations ~~and financial condition~~.

InCertain ~~addition~~of our employees, contractors and vendors have access to and use personal information in the ~~expense~~ordinary ~~associated~~course ~~with~~of ~~increased~~our ~~manufacturing~~business. The secure processing, ~~sales~~maintenance and ~~marketing~~transmission toof ~~meet~~this ~~increased~~information ~~demand~~is ~~may~~critical ~~exceed~~to our ~~expectations~~operations. ~~Further,~~Despite weour ~~manufacture~~security measures and business controls, our ~~ICLs~~information technology and infrastructure have in the Upast and may in the future be subject to attacks by hackers, breaches due to employee, contractor or vendor error, or malfeasance, systems error (whether as a result of an intentional breach, a natural disaster or human error) or other disruptions or subject to the inadvertent or intentional unauthorized release of information.S Any such occurrence could compromise our networks and the information stored thereon could be accessed, publicly disclosed, lost or stolen. Any such access, ~~and~~disclosure ~~inflationary~~or ~~pressures~~other loss of information could result in ~~increased~~legal ~~costs~~claims inor proceedings, and liability under laws that protect the privacy of personal information and regulatory penalties, disrupt our operations and the supply ~~chain~~of products we provide to our clients, compromise our intellectual property or other confidential business information, or damage our reputation, any of which could adversely affect our profitability, revenue and competitive position. Many of our employees currently work remotely, which may bemake ~~difficult~~us more vulnerable to ~~pass~~cyberattacks. ~~along~~While we have not experienced a material system failure, accident or security breach to date, we cannot assure you that our ~~customers.~~data ~~Any~~protection ~~inability~~efforts toand ~~successfully~~our ~~manage~~investment ~~growth~~in information technology will prevent significant breakdowns, data leakages, breaches in our systems or other cyber incidents that could ~~materially~~have ~~and~~a ~~adversely~~material ~~affect~~adverse effect upon our reputation, business, operations or financial condition. We continue to invest in our cybersecurity program to enhance current capabilities and also implement new capabilities in our effort to keep pace with the changing threat landscape. Also, certain of our information technology systems are not redundant, and our disaster recovery planning is not sufficient for every eventuality. Despite any precautions we may take, such events could materially harm our reputation and financial results. Moreover, while we maintain cyber insurance, it may be insufficient to address any potential loss incurred. We also rely on third parties to host or otherwise process some of ~~operation~~this data (such as cloud-based computing). Elements of our information technology systems that we outsource to third parties may also be vulnerable to various types of attacks or disruptions. Any failure by a third party to prevent security breaches could have adverse consequences for us.

~~Corporate~~We ~~responsibility,~~are ~~specifically~~subject ~~related~~ to ~~environmental,~~various ~~social~~data protection and ~~governance~~privacy regulations in different jurisdictions, including the General Data Protection Regulation (~~ESG~~Regulation (EU) ~~matters~~2016/679) (GDPR) and the California Consumer Privacy Act. We have made and continue to engage in compliance efforts to satisfy these and other regulations, however, we may ~~impose~~be ~~additional~~unsuccessful ~~costs~~in complying with applicable requirements, ~~expose~~and usmay be at risk of enforcement actions and/or subject to ~~reputational~~fines, including those imposed by a data protection authority. As a result, we may incur substantial expense in complying with data protection and ~~emerging~~privacy ~~areas~~regulations, ofexposure ~~risks~~resulting from a data breach, ransomware or non-compliance and ~~could~~may ~~negatively~~be ~~affect~~distracted from other aspects of our business.

In order to comply with global ESG regulations and reporting requirements, we have been investing in our ESG resources and capabilities. Further, some investors, stockholders, customers, suppliers and other third parties have been increasingly focusing on ESG and corporate responsibility practices and reporting. Companies that do not adapt to or comply with the evolving regulations, requirements, expectations and standards, or which are perceived to have not responded appropriately, may suffer from reputational damage and result in the business, financial condition and/or stock price of a company being materially and adversely affected. This may result in a significant increase in additional expenses (e.g., direct or indirect cost of energy, materials, manufacturing, distribution, packaging and other operating costs) to comply with evolving regulations and/or third-party requirements that could adversely impact our business or profitability. 24

InThe ~~response~~increased touse ~~certain stakeholder expectations, we have commenced reporting~~ of ~~our~~social ~~sustainability~~media ~~endeavors~~platforms and ~~future~~mobile ~~plans.~~technologies ~~These~~presents ~~disclosures~~additional ~~reflect our current aspirations and are not guarantees that we will be able to achieve them. Our efforts to accomplish and accurately report on these plans present numerous~~ risks, any of which could have a material negative impact on us. Our pursuit of certain practices, as well as our ability to achieve any goal, including with respect to ESG-related initiatives, is subject to numerous risks, many of which are outside of our control. Certain shareholders may reduce or eliminate their holdings of our stock based on ESG issues. At the same time, certain stakeholders and regulators have increasingly expressed or pursued opposing views, legislation and investment expectations with respect to sustainability initiatives, including the enactment or proposal of “Anti-ESG” legislation or policieschallenges. If our sustainability practices do not meet evolving investor or other stakeholder expectations and standards or if we are unable to satisfy all stakeholders, our reputation, our ability to attract or retain employees, our sales and our attractiveness as an investment or business partner could be negatively impacted. Similarly, our failure or perceived failure to pursue or fulfill certain targets or goals, or to satisfy various reporting standards could also have negative impacts and expose us to government enforcement actions and private litigation.

~~Finally,~~Social wemedia ~~expect~~platforms and mobile technologies are increasingly being used to ~~incur~~communicate ~~additional~~about ~~costs~~our products and ~~require~~the ~~additional~~health ~~resources~~conditions they are intended to ~~monitor,~~treat. ~~report,~~Their ~~and~~use ~~comply~~poses ~~with~~risks to our ~~various~~business ~~ESG~~and ~~practices~~requires specific attention and monitoring. For example, aspatients, ~~well~~surgeons, ascompetitors, ~~new~~or ~~and~~others ~~anticipated~~may ~~global~~use ~~regulations~~these ~~focused~~channels to comment on ~~ESG.~~our Ifproducts, weincluding ~~fail~~the safety or effectiveness of a product and to ~~adopt~~report ~~ESG~~an ~~standards~~alleged oradverse ~~practices~~event. asNegative ~~quickly~~posts asor ~~some~~comments ~~stakeholders~~about ~~desire,~~us ~~report~~or our business on any social networking web site could harm our ~~efforts~~reputation. orIn ~~practices~~addition, ~~accurately~~our employees may use social media tools and mobile technologies inappropriately, which may give rise to liability, or ~~satisfy~~which could lead to the ~~expectations~~exposure of ~~our~~sensitive ~~various~~information. ~~stakeholders~~In ~~who~~either ~~have~~case, ~~varied~~such ~~perspectives~~uses onof ~~sustainability~~social ~~practices~~media and ~~global~~mobile ~~regulators,~~technologies ~~our~~could ~~reputation,~~have a material adverse effect on our business, financial ~~performance~~condition, and ~~growth~~results ~~may~~of ~~be adversely impacted~~operations.

~~Climate~~Acquisitions ~~changes~~of ~~and~~technologies, ~~extreme~~products, ~~weather~~and ~~conditions~~businesses could ~~negatively~~disrupt ~~affect~~ our ~~business~~operations, involve increased expenses and present risks not contemplated at the time of the transactions.

~~Climate~~We ~~changes~~may consider and, ~~extreme~~as ~~weather~~appropriate, ~~conditions~~make ~~could~~acquisitions ~~create~~of ~~financial risk to our business. Global physical climate changes~~technologies, ~~including unseasonable weather conditions and earthquakes~~products, ~~could disrupt our operations by impacting the availability~~ and ~~cost~~businesses ofthat ~~water,~~we ~~energy,~~believe orare ~~materials~~complementary ~~within~~to our ~~supply~~business. ~~chain,~~Acquisitions ~~and~~typically ~~could~~entail ~~also~~many ~~increase~~risks ~~insurance~~ and ~~other~~could ~~operating~~result ~~costs.~~in ~~This~~difficulties ~~could~~ in ~~turn~~integrating ~~put~~the ~~pressure~~operations, onpersonnel, ~~our~~technologies, ~~manufacturing costs~~ and ~~result~~products inacquired, ~~reduced~~and ~~profit~~mitigating ~~margins~~the ~~associated~~risk ~~with certain~~ of ~~our~~unknown ~~products.~~liabilities Insome ~~the~~of ~~U.S.,~~which wemay ~~have~~result ~~several~~in ~~offices~~significant ~~and~~payments ~~facilities~~or ~~located~~charges into earnings.

24If we are unable to successfully integrate our acquisitions with our existing business, we may not obtain the advantages that the acquisitions were intended to create, which may materially adversely affect our business, and our ability to develop and introduce new products. Actual costs and sales synergies, if achieved at all, may be lower than we expect and may take longer to achieve than we anticipate. Acquisitions may also divert management’s attention from our core business. Furthermore, the products of companies we acquire may overlap with our products or those of our customers, creating conflicts with existing relationships or with other commitments that are detrimental to the integrated businesses.

~~Southern~~If ~~California,~~we ~~which~~are ~~has~~not ~~experienced~~able ~~weather~~to ~~events~~manage ~~and~~growth ~~fires~~successfully, ~~and~~it ~~is a region where earthquakes~~ could ~~cause~~adversely ~~catastrophic~~affect ~~loss. Climate changes and extreme weather conditions could impact~~ our ~~facilities and employees in Southern California and around the world. Climate-related transitional risks~~business, ~~such~~financial ~~as changing regulations~~condition, ~~could also increase our costs~~ and ~~adversely~~results ~~impact~~of ~~our~~ operations ~~or financial performance~~.

~~Risks~~While ~~Related~~our net sales decreased in fiscal 2025 compared to fiscal 2024, we intend to return to sales growth. Growth can place a significant strain on our financial, operational, and managerial resources. In order to support our growth, we must continue to implement and enhance our managerial, operational and financial systems, expand our operations, and continue to recruit and train qualified personnel. There can be no assurance that our strategic and operational planning will allow us to adequately manage anticipated growth. Factors such as a failure to follow specific internal practices and procedures, equipment malfunction, environmental factors or damage to one or more of our facilities could adversely affect our ability to manufacture our products. For example, in the ~~Ophthalmic~~second ~~Products~~half ~~Industry~~of 2021, as we increased production to meet increased demand, we experienced a decline in product yield. In the event of a slower-than-planned manufacturing output, we may be unable to quickly meet customer demand. In the event of a significant manufacturing challenge, we may experience delays in meeting product demand which could adversely affect our results of operations and financial condition.

~~Unless~~In weaddition, ~~keep~~the ~~pace~~expense associated with ~~advances~~increased inmanufacturing, sales and marketing to meet increased demand may exceed our ~~industry~~expectations. Further, our principal ICL manufacturing facility is in the U.S., and ~~persuade~~inflationary ~~physicians~~pressures could result in increased costs in our supply chain, which may be difficult to ~~adopt~~pass along to our ~~new~~customers. ~~products~~In addition, as we ramp up ICL manufacturing in Nidau, Switzerland, our ~~sales~~costs are expected to increase given the expense of operating two sites and lower site utilization impacts cost absorption. We expect the on-going operation of two manufacturing sites will ~~not~~create ~~grow~~pressure on gross margins and ~~may~~will ~~decline~~lead to higher inventory levels in the near-term. As our ICLs have a shelf life of three years, if we are unable to align our manufacturing with forecasted demand, higher inventory levels could require write-downs for excess, slow moving, expiring and obsolete inventory.

~~Our~~Further, ~~future~~we ~~growth~~are ~~depends,~~investing in ~~part,~~new onenterprise ~~our~~resource ~~ability~~planning to(ERP) ~~timely~~and ~~develop~~other ~~products~~technology toplatforms ~~treat diseases~~ and ~~disorders~~systems ofto ~~the~~help ~~eye~~support ~~that~~our ~~are~~future ~~more~~growth ~~effective,~~plans. ~~safer,~~Implementing ora ~~incorporate~~new ~~emerging~~ERP ~~technologies~~system ~~better~~is ~~than~~not ~~our~~only ~~competitors’ products~~costly, ~~and~~but ~~are~~it ~~accepted~~is bycomplex ~~physicians~~ and ~~patients.~~exposes ~~Sales~~us ofto ~~our~~potential ~~existing~~risks. ~~products~~ERP ~~may~~implementations ~~decline~~can ~~rapidly~~negatively ifaffect ~~one~~financial ofaccounting ~~our~~and ~~competitors~~reporting ~~introduces~~processes, aas ~~superior~~well ~~product,~~as orexternal ifcommercial weactivities, ~~announce~~such aas ~~new~~ICL ~~product~~ordering ofand ~~our own~~delivery. IfWe wecannot ~~focus~~be onassured ~~research and development or technologies~~ that dowe ~~not~~will ~~lead~~successfully toimplement ~~better~~our ~~products,~~new ~~more~~ERP ~~effective~~system or ~~advanced~~that ~~products~~we ~~could~~will ~~surpass~~avoid ~~our~~these ~~current~~ and ~~planned~~other ~~products.~~negative Inimpacts ~~addition,~~from ~~such~~our ~~product~~implementation ~~development~~ efforts ~~could require a significant investment of resources~~. If we ~~are~~do ~~able~~not toeffectively ~~develop~~implement ~~new~~the ~~products,~~ERP wesystem ~~must~~as ~~manufacture~~planned, ~~these~~or ~~products~~it ~~economically~~does ~~and~~not ~~market~~operate ~~them~~as ~~successfully~~intended, bythe ~~demonstrating~~effectiveness toof ~~enough~~our ~~eye-care~~internal ~~professionals~~control ~~the~~over ~~overall~~financial ~~benefits~~reporting ofcould ~~using~~also ~~them~~be adversely affected. IfIn addition, we docannot ~~not~~assure ~~timely~~that ~~develop~~our new ~~products~~ERP ~~that~~system, ~~meet~~and ~~market~~other ~~demand~~technology orplatforms ifand ~~there~~systems isthat ~~insufficient~~we ~~demand~~use ~~for~~now ~~our~~or ~~new~~implement ~~products,~~in ~~our~~the ~~sales~~future, ~~and~~will ~~results~~meet ofour ~~operations~~business ~~could~~needs beand ~~harmed. For~~support ~~example,~~our itgrowth isas ~~uncertain~~intended. ~~whether~~We ~~physicians~~also incannot ~~countries~~assure that ~~recognize~~there ~~the CE Mark~~ will ~~adopt~~not ~~the~~be ~~EVO~~associated ~~Viva~~excessive ~~lens~~costs ~~for~~or ~~use~~disruptions in ~~presbyopic~~portions ~~eyes,~~of ~~which~~ our ~~Notified~~business ~~Body~~in ~~approved~~the ~~for~~course ~~marketing~~of ~~and~~our ~~sale~~maintenance, ~~in July 2020.~~

~~Resources devoted to research and development may not yield new ophthalmic products that achieve regulatory approval or commercial success.~~25

~~Development~~support ~~of new implantable technology, from discovery through testing~~ and/or ~~registration~~upgrade toof ~~initial~~these ~~product launch, is expensive and time-consuming~~systems. ~~Because~~Any ofinability ~~the~~to ~~complexities~~successfully ~~and~~manage ~~uncertainties~~growth ofcould ~~ophthalmic~~materially ~~research~~ and ~~development,~~adversely ~~products~~affect weour ~~are developing~~business, ~~including~~financial ~~those currently in development~~condition, ~~may~~and ~~not~~results ~~complete~~of ~~the development process or obtain the regulatory approvals required for us to successfully market the products~~operation. ~~Our new products, including those currently under development, may fail to become commercially successful.~~

WeCorporate ~~may~~responsibility, bespecifically ~~required~~related to ~~conduct~~environmental, ~~extensive~~social ~~clinical trials to demonstrate safety~~ and ~~effectiveness~~governance of(ESG) ~~new~~matters, ormay ~~enhanced~~impose ~~ophthalmic~~additional ~~products~~costs, ~~such~~expose ~~clinical~~us ~~trials~~to ~~are~~reputational ~~expensive,~~and ~~complex,~~emerging ~~can~~areas ~~take~~of ~~years to complete~~risks, and ~~have~~could ~~highly~~negatively ~~uncertain~~affect ~~outcomes~~our business.

In order to ~~further~~comply ~~advance~~with ~~the~~global ~~development~~ESG ~~of,~~regulations and ~~ultimately~~reporting ~~receive~~requirements, ~~regulatory~~we ~~approval~~have tobeen ~~manufacture~~investing ~~and~~in ~~sell,~~ our ~~new~~ESG ~~ophthalmic~~resources ~~products~~and orcapabilities. ~~product~~Further, ~~enhancements~~some investors, westockholders, ~~may~~customers, besuppliers ~~required~~and toother ~~conduct~~third ~~extensive~~parties ~~clinical~~have ~~trials~~been toincreasingly ~~demonstrate~~focusing ~~their~~on ~~safety~~ESG and ~~effectiveness~~corporate toresponsibility ~~the~~practices ~~satisfaction~~and ~~of the U~~reporting.S. ~~FDA~~Companies orthat ~~regulatory~~do ~~authorities~~not inadapt ~~other~~to ~~countries.~~or ~~Clinical~~comply ~~trials~~with ~~are~~the ~~expensive~~evolving regulations, ~~complex~~requirements, ~~can~~expectations ~~take~~and ~~many~~standards, ~~years~~or towhich ~~complete,~~are ~~and~~perceived to have ~~highly~~not ~~uncertain~~responded ~~outcomes. Delays~~appropriately, ~~setbacks,~~may orsuffer ~~failures~~from ~~can~~reputational ~~occur~~damage atand ~~any~~result ~~time~~in the business, orfinancial incondition ~~any~~and/or ~~phase~~stock price of ~~the~~a ~~clinical~~company ~~trials,~~being materially and ~~can~~adversely ~~result~~affected. ~~from~~This ~~concerns~~may ~~about~~result ~~safety,~~in a ~~lack~~significant ofincrease ~~demonstrated~~in ~~effectiveness~~additional expenses (e.g., direct or ~~poor~~indirect ~~study~~cost orof ~~trial~~energy, ~~design. The~~materials, ~~commencement~~manufacturing, distribution, packaging and ~~completion~~other ofoperating ~~clinical~~costs) ~~trials~~to ~~may~~comply bewith ~~delayed~~evolving regulations and/or ~~prevented~~third-party byrequirements ~~many~~that ~~factors,~~could ~~including,~~adversely ~~but~~impact ~~not~~our ~~limited~~business ~~to:~~or profitability.

anIn ~~inability~~response to ~~reach~~certain ~~agreement~~stakeholder expectations, we have commenced reporting of our sustainability endeavors and future plans. These disclosures reflect our current aspirations and are not guarantees that we will be able to achieve them. Our efforts to accomplish and accurately report on these plans present numerous risks, any of which could have a material negative impact on us. Our pursuit of certain practices, as well as our ability to achieve any goal, including with ~~regulatory~~respect ~~authorities~~to ~~regarding~~ESG-related initiatives, is subject to numerous risks, many of which are outside of our control. Certain shareholders may reduce or eliminate their holdings of our stock based on ESG issues. At the ~~scope~~same time, certain stakeholders and regulators have increasingly expressed or ~~extent~~pursued opposing views, legislation and investment expectations with respect to sustainability initiatives, including the enactment or proposal of a“Anti-ESG” ~~proposed~~legislation ~~clinical~~or ~~trial;~~policies. If our sustainability practices do not meet evolving investor or other stakeholder expectations and standards or if we are unable to satisfy all stakeholders, our reputation, our ability to attract or retain employees, our sales and our attractiveness as an investment or business partner could be negatively impacted. Similarly, our failure or perceived failure to pursue or fulfill certain targets or goals, or to satisfy various reporting standards could also have negative impacts and expose us to government enforcement actions and private litigation.

anFinally, ~~inability~~we expect to ~~timely~~incur ~~identify~~additional costs and ~~reach~~require ~~agreement~~additional onresources ~~acceptable~~to ~~terms~~monitor, report, and comply with ~~prospective~~our ~~clinical~~various ~~trial~~ESG ~~sites~~practices, as well as new and ~~entities~~anticipated ~~involved~~global inregulations focused on ESG. If we fail to adopt ESG standards or practices as quickly as some stakeholders desire, report on our efforts or practices accurately, or satisfy the ~~conduct~~expectations of our ~~clinical~~various ~~trials;~~stakeholders who have varied perspectives on sustainability practices and global regulators, our reputation, business, financial performance and growth may be adversely impacted.

~~failure~~Climate bychanges ~~third-party~~and ~~clinical~~extreme ~~trial~~weather ~~managers~~conditions tocould ~~comply~~negatively ~~with~~affect ~~applicable~~our ~~regulations or protocols;~~business.

~~flaws~~Climate inchanges and extreme weather conditions could create financial risk to our business. Global physical climate changes, including unseasonable weather conditions and earthquakes, could disrupt our operations by impacting the ~~design~~availability and cost of water, energy, or materials within our supply chain, and could also increase insurance and other operating costs. This could in turn put pressure on our manufacturing costs and result in reduced profit margins associated with certain of our products. In the ~~clinical~~U.S., ~~trials;~~we have several offices and facilities located in Southern California, which has experienced weather events and fires and is a region where earthquakes could cause catastrophic loss. Climate changes and extreme weather conditions could impact our facilities and employees in Southern California and around the world. Climate-related transitional risks, such as changing regulations, could also increase our costs and adversely impact our operations or financial performance.

~~slower~~Risks ~~than~~Related ~~expected~~to ~~rates~~the ofOphthalmic ~~patient~~Products ~~recruitment and enrollment;~~Industry

~~periodic~~Unless ~~amendments~~we tokeep ~~clinical~~pace ~~trial~~with ~~protocols~~advances in our industry and persuade physicians to ~~address~~adopt ~~certain~~our ~~variables~~new ~~which~~products, ~~arise~~our ~~during~~sales ~~the~~will ~~course~~not ofgrow aand ~~trial;~~may decline.

~~lack~~Our offuture ~~effectiveness~~growth depends, in part, on our ability to timely develop products to treat diseases and disorders of the eye that are more effective, safer, or incorporate emerging technologies better than our competitors’ products;, and are accepted by physicians and patients. Physicians and patients initially adopted our EVO ICL for the treatment of high myopia, and in order to continue growing, we need to increase adoption for the treatment of low and moderate myopia. Persuading physicians to adopt and grow their use of a new product or technology is challenging, and if we are unsuccessful, our sales will not grow and may decline.

~~unforeseen safety issues.~~26

25In addition, sales of our existing products may decline rapidly if one of our competitors introduces a superior product, or if we announce a new product of our own. If we focus on research and development or technologies that do not lead to better products, more effective or advanced products could surpass our current and planned products. In addition, such product development efforts could require a significant investment of resources. If we are able to develop new products, we must manufacture these products economically and market them successfully by demonstrating to enough eye-care professionals the overall benefits of using them. If we do not timely develop new products that meet market demand or if there is insufficient demand for our new products, our sales and results of operations could be harmed. For example, it is uncertain whether physicians in countries that recognize the CE Mark will adopt the EVO Viva lens for use in presbyopic eyes, which our Notified Body approved for marketing and sale in July 2020.

~~Complying~~Resources ~~with~~devoted ~~government~~to ~~regulation~~research ~~substantially~~and ~~increases~~development ~~the~~may ~~cost~~not ofyield ~~developing,~~new ~~manufacturing~~ophthalmic ~~and~~products ~~selling~~that ~~our~~achieve ~~ophthalmic~~regulatory ~~products~~approval or commercial success.

~~Competing~~STAAR inhas ~~the~~limited ~~ophthalmic~~product ~~products~~offerings, ~~industry~~with ~~requires~~nearly usall toof ~~introduce~~our ~~new~~net orsales ~~improved~~from ~~products~~EVO and ~~processes~~EVO+ ~~continuously~~ICLs, ~~and~~which tocreates ~~submit~~a ~~these~~heightened torisk profile for the UCompany.S. ~~FDA~~In ~~and~~order ~~other~~to ~~regulatory~~be ~~bodies~~successful, ~~for~~we ~~clearance~~will orneed ~~approval.~~to ~~Obtaining~~continue ~~clearance~~to launch new products or ~~approval~~replace ~~can~~our beexisting aproducts. ~~long~~Development ~~and~~of ~~expensive~~new ~~process~~implantable technology, from discovery through testing and ~~clearance~~registration orto ~~approval~~initial product launch, is ~~never~~expensive ~~certain~~and time-consuming. ~~For~~Because ~~example,~~of the ~~U.S.~~complexities ~~FDA~~and oruncertainties ~~another~~of ~~country’s~~ophthalmic ~~regulatory~~research ~~agency~~and development, ~~could~~products ~~require~~we usare todeveloping, ~~conduct~~including anthose ~~additional~~currently ~~clinical~~in ~~trial~~development, ~~prior~~may tonot ~~granting~~complete ~~clearance~~the ordevelopment ~~approval~~process ofor aobtain ~~product~~the ~~and~~regulatory ~~such~~approvals ~~clinical~~required ~~trial~~for ~~could~~us ~~take~~to asuccessfully ~~long~~market ~~time~~the ~~and~~products. ~~have~~Our ~~substantial~~new ~~expense. Furthermore~~products, ~~there~~including isthose nocurrently ~~assurance~~under ~~that~~development, ~~clearance~~may orfail ~~approval~~to ~~will~~become becommercially ~~granted~~successful.

IfWe amay ~~regulatory~~be ~~authority~~required ~~delays~~to orconduct ~~does~~extensive ~~not~~clinical ~~grant~~trials ~~approval~~to ofdemonstrate asafety ~~potentially significant product, the potential sales of the product~~ and ~~its~~effectiveness ~~value to us can be substantially reduced. Even if the U.S. FDA or another regulatory agency clears or approves a product, the clearance or approval may limit the indicated patient populations or uses~~ of ~~the~~new ~~product,~~ or ~~may~~enhanced ~~otherwise~~ophthalmic ~~limit our ability to promote~~products, ~~sell~~such ~~and~~clinical ~~distribute~~trials ~~the~~are ~~product, or may require~~ expensive ~~post-marketing studies or surveillance. If we cannot obtain timely regulatory clearance or approval of our new products~~, ~~or if the clearance or approval is too narrow~~complex, wecan ~~will~~take ~~not~~years ~~be able~~ to ~~successfully market these products~~complete, ~~which~~and ~~would~~have ~~eliminate~~highly oruncertain ~~reduce our potential sales and earnings~~outcomes.

In ~~addition,~~order to further advance the ~~U.S.~~development ~~FDA~~of, and ~~other~~ultimately receive regulatory ~~authorities~~approval to manufacture and sell, our new ophthalmic products or product enhancements, we may ~~change~~be required to conduct extensive clinical trials to demonstrate their ~~clearance~~safety and ~~approval~~effectiveness ~~policies,~~to ~~adopt~~the ~~additional~~satisfaction ~~regulations,~~of the U.S. FDA or ~~revise~~regulatory ~~existing~~authorities ~~regulations~~in other countries. Clinical trials are expensive, orcomplex, can take ~~other~~many ~~actions~~years ~~which~~to ~~may~~complete, ~~prevent~~and orhave ~~delay~~highly ~~approval~~uncertain outcomes. Delays, setbacks, or ~~clearance~~failures ofcan ~~our~~occur ~~products~~at ~~under~~any ~~development~~time, ~~cause~~or ~~the~~in ~~loss~~any phase of ~~previously~~the ~~received~~clinical ~~approvals~~trials, orand ~~clearances~~can orresult ~~impact~~from ~~our~~concerns ~~ability~~about tosafety, ~~modify~~a ~~our~~lack ~~currently~~of ~~cleared~~demonstrated ~~products~~effectiveness, onor apoor ~~timely~~study ~~basis~~or trial design. ~~Also,~~ weThe ~~expect~~commencement toand ~~incur~~completion ~~additional~~of ~~costs~~clinical ~~complying~~trials ~~with~~may ~~the~~be ~~European~~delayed ~~Union’s~~or ~~new~~prevented ~~Medical~~by ~~Device~~many ~~Regulation.~~factors, including, but not limited to:

•

Wean ~~depend~~inability onto ~~proprietary~~reach ~~technology,~~agreement ~~but~~with ~~our~~regulatory ~~intellectual~~authorities ~~property~~regarding ~~protections~~the ~~may~~scope beor ~~limited.~~extent of a proposed clinical trial;

•

While we rely on various intellectual property laws, contractual provisions and confidentiality procedures and copyright laws to protect the proprietary aspects of our technology, we rely more on trade secrets and know-how, which may not prevent third parties from using publicly available information to access our technology. The ophthalmic industry is competitive, and new products and technologies are regularly being brought to market. With respect to our patents, any of them may be challenged, invalidated, circumvented or rendered unenforceable. Any of our pending patent applications may fail to result in an ~~issued~~inability ~~patent or fail~~ to ~~provide~~timely ~~meaningful~~identify ~~protection against competitors or competitive technology. Litigation may be necessary to enforce our intellectual property rights,~~ and toreach ~~protect~~agreement or determine the validity and scope of our proprietary rights. We also challenge others’ patents or patent applications from time to time. Any litigation could result in substantial expense, may reduce our profits, and may not adequately protect our intellectual property rights. In addition, we may be exposed to future litigation by third parties based on ~~claims~~acceptable ~~that~~terms ~~our~~with ~~products~~prospective ~~infringe~~clinical ~~their~~trial ~~intellectual~~sites ~~property rights. This risk is exacerbated by the fact that the validity~~ and ~~breadth~~entities ofinvolved ~~claims covered by patents~~ in our industry may involve complex legal issues that are open to dispute. Any litigation or claims against or instituted by us, whether or not successful, could result in substantial costs, divert resources and the ~~efforts~~conduct of our ~~personnel~~clinical away from daily operations, harm our reputation, result in the impairment of our intellectual property rights, limit our ability to pursue future products and/or otherwise materially adversely impact our business.trials;

•

Wefailure ~~may~~by ~~not~~third-party ~~successfully~~clinical ~~replace~~trial ~~our~~managers ~~existing~~to ~~products,~~comply ~~including~~with ~~those~~applicable ~~that~~regulations ~~lose~~ or ~~have lost patent protection.~~protocols;

•

Asflaws ~~our~~in ~~existing~~the ~~patents~~design ~~expire, many~~ of ~~which already expired over~~ the ~~past~~clinical several years, our competitors may introduce products using the same technology. Because of this possible increase in competition, we may lose sales and/or may need to reduce our prices to maintain sales of our products, which would make them less profitable. If we fail to develop and successfully launch new products and/or obtain new patents, our sales and profits with respect to our products could decline significantly. We may not be able to develop and successfully launch more advanced replacement products.trials;

•

~~While~~slower wethan ~~will~~expected ~~continue~~rates ~~developing~~of ~~intellectual~~patient ~~property~~recruitment ~~protections~~and ~~for our future products, third parties may pursue blocking patents that limit our ability to manufacture such products.~~enrollment;

•

Weperiodic ~~plan~~amendments to ~~continue~~clinical ~~relying~~trial onprotocols ~~our intellectual property rights~~ to ~~protect~~address ~~products~~certain ~~and~~variables ~~technology~~which ~~that~~arise weduring ~~may develop or employ in~~ the ~~future,~~course ~~but~~of ~~third~~a parties may develop and obtain patents covering such products or technology. In such event, we may need to obtain licenses for such patents. However, we may not be able to obtain licenses on reasonable terms, if at all, which could limit our ability to manufacture our future products and operate our business.trial;

•

26lack of effectiveness of our products; or

•

~~Risks~~unforeseen ~~Related~~safety ~~to Regulatory and Compliance~~issues.

WeComplying ~~are~~with ~~subject to extensive~~ government regulation ~~worldwide,~~substantially ~~which~~ increases ~~our~~the ~~costs~~cost ~~and~~of ~~could~~developing, ~~prevent~~manufacturing usand ~~from~~ selling our ophthalmic products.

WeCompeting ~~are regulated by regional, national, state and local agencies~~ in the ~~U.S.~~ophthalmic asproducts ~~well~~industry asrequires ~~governmental~~us ~~authorities~~to inintroduce ~~those~~new ~~countries in which we manufacture~~ or ~~distribute~~improved products. ~~These~~and ~~regulations~~processes ~~may govern the research~~continuously, ~~development, manufacturing,~~ and ~~commercial~~to ~~activities~~submit ~~relating~~these to ~~medical~~the ~~devices,~~U.S. ~~including~~FDA ~~their~~and ~~design,~~other ~~pre-clinical~~regulatory ~~and~~bodies ~~clinical~~for ~~testing,~~ clearance or approval~~, production, labeling, sale, distribution, import, export, post-market surveillance, advertising, dissemination of information and promotion~~. ~~Failure~~Obtaining toclearance ~~receive~~or ~~necessary~~approval ~~approvals~~can inbe ~~international jurisdictions on~~ a ~~timely~~long ~~basis,~~and orexpensive ~~at all~~process, ~~could~~and ~~harm~~clearance ~~our~~or ~~business~~approval ~~and~~is ~~operating~~never ~~results~~certain. InFor ~~addition~~example, ~~regulations~~the ~~and~~U.S. ~~requirements~~FDA ~~for~~or ~~approvals~~another ~~vary~~country’s byregulatory ~~country~~agency, ~~which~~could ~~can~~require ~~significantly~~us ~~increase the costs~~ to ~~sell~~conduct ~~our~~an ~~products~~additional inclinical ~~these~~trial ~~international~~prior ~~jurisdictions.~~to ~~Any~~granting ~~failure~~clearance toor ~~comply~~approval ~~with~~of ~~applicable~~a ~~legal~~product and ~~regulatory~~such ~~obligations~~clinical trial could ~~result~~take ina ~~fines~~long ~~and~~time ~~penalties, restrictions on certain business activities,~~ and ~~other~~have ~~remedial~~substantial ~~measures,~~expense. ~~which if significant~~Furthermore, ~~could~~there ~~disrupt~~is ofno ~~our~~assurance ~~operations,~~that ~~distract~~clearance ~~management,~~or ~~and~~approval ~~harm~~will ~~our~~be ~~business~~granted.

~~Regulatory issues may adversely impact our operations.~~27

If wea ~~cannot~~regulatory ~~maintain~~authority ~~compliance~~delays ~~with~~or adoes ~~particular~~not ~~jurisdiction’s~~grant ~~regulatory~~approval ~~requirements,~~of ita ~~could~~potentially ~~adversely~~significant ~~impact~~product, ~~our~~the ~~financial~~potential ~~performance~~sales ~~and~~of ~~have~~the aproduct ~~material~~and ~~adverse~~its ~~effect~~value onto ~~our~~us ~~ongoing~~can ~~business~~be ~~and~~substantially ~~operations~~reduced. WeEven ~~plan~~if tothe ~~remain~~U.S. inFDA ~~compliance~~or ~~with~~another regulatory ~~requirements~~agency ~~established~~clears byor ~~applicable~~approves ~~global~~a ~~regulatory agencies~~product, ~~however,~~the ~~there~~clearance ~~can~~or beapproval nomay ~~guaranty~~limit ~~that~~the weindicated ~~will~~patient dopopulations ~~so.~~or Weuses ~~expect~~of tothe ~~continue~~product, or may otherwise limit our ability to ~~devote~~promote, ~~resources~~sell and ~~attention~~distribute tothe ~~our~~product, ~~quality~~or ~~systems~~may ~~and~~require ~~compliance~~expensive ~~and~~post-marketing ~~other~~studies or surveillance. If we cannot obtain timely regulatory ~~requirements~~clearance asor ~~part~~approval of ~~the~~our ~~ordinary~~new ~~course~~products, ofor ~~business.~~if Wethe ~~cannot~~clearance ~~ensure~~or ~~that~~approval ~~our~~is ~~efforts~~too ~~will~~narrow, bewe ~~successful~~will ~~and~~not ~~failure~~be able to ~~achieve~~successfully ormarket ~~maintain~~these ~~compliance~~products, ~~may~~which ~~materially~~would ~~and~~eliminate ~~adversely~~or ~~impact~~reduce our ~~business~~potential sales and ~~operations~~earnings.

~~Laws~~In ~~pertaining~~addition, tothe ~~healthcare~~U.S. ~~fraud~~FDA and ~~abuse~~other ~~could~~regulatory ~~materially~~authorities ~~adversely~~may ~~affect~~change ~~our~~their ~~business~~clearance and approval policies, ~~financial~~adopt ~~condition~~additional regulations, ~~and~~or ~~results~~revise existing regulations, or take other actions which may prevent or delay approval or clearance of ~~operations~~our products under development, cause the loss of previously received approvals or clearances or impact our ability to modify our currently cleared products on a timely basis. Also, we expect to incur additional costs complying with the European Union’s new Medical Device Regulation.

~~Our~~We ~~relationships~~depend ~~with~~on ~~physicians,~~proprietary ~~and other healthcare providers are subject to scrutiny under various U.S. and international bribery~~technology, ~~fraud~~but and abuse, anti-kickback, false claims, privacy, and similar laws, collectively referred to as “healthcare compliance laws.” Healthcare compliance laws are broad, sometimes ambiguous, complex, and subject to change and changing interpretations, which could restrict our ~~sales~~intellectual orproperty ~~marketing~~protections ~~practices.~~may ~~Possible~~be sanctions for violation of these healthcare compliance laws include fines, civil and criminal penalties, exclusion from government healthcare programs, and despite our compliance efforts, we face the risk of an enforcement activity or a finding of a violation of these lawslimited. For example, in 2022 a Japanese trade association (Japan Fair Trade Council of the Medical Devices Industry) ruled that our subsidiary in Japan improperly implemented a program with surgeons and hospitals to obtain videos of cataract surgeries where our cataract intraocular lenses were used.

WeWhile ~~have~~we ~~entered~~rely ~~into~~on avarious ~~variety~~intellectual ofproperty ~~agreements~~laws, ~~with~~contractual ~~healthcare~~provisions ~~professionals.~~and Weconfidentiality ~~have~~procedures ~~also~~and ~~adopted~~copyright alaws ~~Code~~to ofprotect ~~Business~~the ~~Conduct~~proprietary ~~and~~aspects ~~Ethics~~of asour ~~well~~technology, aswe arely ~~Compliance~~more ~~Program~~on ~~for~~trade ~~Interactions~~secrets ~~with~~and ~~Healthcare~~know-how, ~~Professionals~~ which ~~govern~~may ~~our~~not ~~relationships~~prevent ~~with~~third ~~healthcare~~parties ~~professionals~~from using publicly available information to ~~bolster~~access our ~~compliance~~technology. ~~with~~The ~~healthcare~~ophthalmic ~~compliance~~industry ~~laws.~~is ~~While~~competitive, ~~our~~and ~~relationships~~new ~~with~~products ~~healthcare~~and ~~professionals~~technologies are ~~structured~~regularly being brought to ~~comply~~market. ~~with~~With ~~applicable~~respect ~~laws~~to ~~and~~our wepatents, ~~provide~~any ~~training~~of onthem ~~these~~may ~~laws~~be ~~and~~challenged, ~~our~~invalidated, ~~Code~~circumvented ~~and~~or ~~Program,~~rendered itunenforceable. isAny ~~possible~~of ~~that~~our ~~enforcement~~pending ~~authorities~~patent applications may ~~view~~fail ~~our~~to ~~relationships~~result asin ~~prohibited~~an ~~arrangements~~issued ~~that~~patent ~~must~~or befail ~~restructured~~to provide meaningful protection against competitors or ~~for~~competitive ~~which~~technology. weLitigation ~~would~~may be ~~subject~~necessary to ~~other~~enforce ~~significant~~our ~~civil~~intellectual orproperty ~~criminal~~rights, ~~penalties~~and orto ~~debarment.~~protect Inor ~~any~~determine ~~event,~~the ~~any~~validity ~~enforcement~~and ~~review~~scope of our proprietary rights. We also challenge others’ patents or ~~action~~patent ~~against~~applications usfrom astime ato time. Any litigation could result ofin ~~such~~substantial ~~review~~expense, ~~regardless~~may ofreduce ~~outcome~~our profits, ~~could~~and bemay ~~costly~~not ~~and~~adequately ~~time~~protect ~~consuming~~our intellectual property rights. ~~Additionally~~In addition, we ~~cannot~~may ~~predict~~be ~~the~~exposed ~~impact~~to offuture ~~any~~litigation ~~changes~~by inthird orparties ~~interpretations~~based ofon ~~these~~claims ~~laws~~that our products infringe their intellectual property rights. IfThis ~~our~~risk ~~operations~~is ~~are~~exacerbated ~~found~~by tothe befact inthat ~~violation~~the ofvalidity ~~any~~and breadth of ~~the~~claims ~~laws~~covered ~~described~~by ~~above~~patents orin ~~any~~our ~~other~~industry ~~governmental~~may ~~regulations~~involve complex legal issues that ~~apply~~are open to usdispute. ~~now~~Any litigation or inclaims ~~the~~against ~~future~~or instituted by us, wewhether ~~may~~or benot ~~subject~~successful, tocould ~~penalties~~result in substantial costs, ~~including~~divert ~~civil~~resources and ~~criminal~~the ~~penalties,~~efforts ~~damages,~~of ~~fines~~our personnel away from daily operations, ~~and~~harm ~~disgorgement~~our reputation, ~~any~~result in the impairment of ~~which~~our ~~could~~intellectual ~~adversely~~property ~~affect~~rights, limit our ability to ~~operate~~pursue ~~our~~future ~~business~~products and/or ~~our~~otherwise ~~financial~~materially ~~results~~adversely impact our business.

IfWe wemay ~~recall~~not asuccessfully ~~product,~~replace ~~the~~our ~~cost~~existing ~~and~~products, ~~damage~~including tothose ~~our~~that ~~reputation~~lose ~~could~~or ~~harm~~have ~~our~~lost ~~business~~patent protection.

WeAs ~~have voluntarily recalled~~ our ~~products~~existing inpatents ~~the~~expire, ~~past~~many ~~and~~of ~~recalls~~which ~~could~~already ~~take~~expired ~~place~~over ~~again.~~the Wepast ~~may~~several ~~also~~years, beour ~~subject~~competitors tomay ~~recalls~~introduce ~~initiated~~products byusing ~~manufacturers~~the ofsame ~~products we distribute~~technology. WeBecause ~~cannot eliminate the risk~~ of athis ~~material~~possible ~~recall~~increase in ~~the~~competition, ~~future.~~we ~~Recalls~~may ~~can~~lose ~~result in lost~~ sales ofand/or ~~the~~may ~~recalled~~need ~~products~~to ~~themselves~~reduce ~~and~~our ~~can~~prices ~~result~~to inmaintain ~~further lost~~ sales ~~while~~of ~~replacement~~our products ~~are manufactured~~, ~~especially~~which ifwould ~~the~~make ~~replacements~~them ~~must~~less beprofitable. ~~redesigned~~If orwe ~~approved~~fail byto ~~regulatory~~develop ~~authorities~~and ~~prior~~successfully tolaunch ~~distribution.~~new ~~If recalled~~ products ~~have~~and/or ~~already~~obtain ~~been~~new ~~implanted~~patents, weour ~~may~~sales ~~bear~~and ~~some~~profits orwith ~~all~~respect ofto ~~the~~our ~~cost~~products ofcould ~~corrective~~decline ~~surgery~~significantly. ~~Recalls~~We may ~~also~~not ~~damage~~be ~~our~~able ~~professional~~to ~~reputation~~develop and ~~the~~successfully ~~reputation~~launch ofmore ~~our~~advanced replacement products. ~~The~~

27While we will continue developing intellectual property protections for our future products, third parties may pursue blocking patents that limit our ability to manufacture such products.

~~inconvenience~~We ~~caused~~plan byto ~~recalls~~continue relying on our intellectual property rights to protect products and ~~related~~technology ~~interruptions~~that we may develop or employ in ~~supply~~the future, ~~the~~but ~~underlying~~third ~~causal~~parties ~~issues,~~may develop and ~~the~~obtain ~~damage~~patents covering such products or technology. In such event, we may need to ~~our~~obtain ~~reputation~~licenses for such patents. However, ~~could~~we ~~cause~~may ~~professionals~~not be able to ~~discontinue~~obtain ~~using~~licenses on reasonable terms, if at all, which could limit our ability to manufacture our future products and operate our business.

~~Companies~~Risks ~~are~~Related ~~required~~ to ~~maintain~~Regulatory certain records of actions, even if they determine such actions are not reportable to the U.S. FDA or other regulatory bodies. If we determine that certain actions do not require notification of the FDA or others, the FDA or other regulatory bodies may disagree with our determinations and require us to report those actions as recalls. In addition, the FDA or other regulatory bodies could take enforcement action for failing to report the recalls when they were conducted or failing to timely report or initiate a reportable product action. Moreover, depending on the corrective action we take to redress a product’s deficiencies or defects, the FDA or other regulatory bodies may require, or we may decide, that we will need to obtain new approvals or clearances for the device before we may market or distribute the corrected device. Seeking such approvals or clearances may delay our ability to replace the recalled devices in a timely manner. Compliance

~~Changes~~We inare ~~U.S.~~subject ~~FDA~~to orextensive ~~international~~government ~~regulations~~regulation ~~related to product approval~~worldwide, ~~including~~which ~~those~~increases ~~that~~our ~~apply~~costs ~~retroactively,~~and could ~~make~~prevent us ~~less~~from ~~competitive~~selling ~~and harm~~ our ~~business~~products.

~~U.S.~~We ~~FDA~~are ~~and~~regulated ~~foreign~~by ~~regulations~~regional, ~~depend heavily on administrative interpretation~~national, state and welocal ~~cannot~~agencies ~~assure~~in ~~investors that future interpretations made by~~ the ~~FDA or other regulatory bodies, with possible retroactive effect, will not adversely affect us~~U.S. ~~Additionally,~~as ~~any~~well ~~changes,~~as ~~whether~~governmental authorities in ~~interpretation~~those orcountries ~~substance,~~ in ~~existing~~which ~~regulations~~we ormanufacture ~~policies,~~ or ~~any~~distribute ~~future~~products. ~~adoption~~These ~~of new~~ regulations ormay ~~policies~~govern bythe ~~relevant~~research, ~~regulatory bodies~~development, ~~could rescind~~manufacturing, ~~prevent~~and orcommercial ~~delay~~activities ~~approval~~relating ofto ~~our~~medical ~~products~~devices, ~~which~~including ~~could~~their ~~materially impact our competitive position~~design, ~~business,~~pre-clinical and ~~financial~~clinical ~~results. Further~~testing, weclearance or ~~our~~approval, ~~distributors~~production, ~~have~~labeling, ~~obtained~~sale, ~~regulatory~~distribution, ~~approvals~~import, ~~outside~~export, ~~the~~post-market ~~United~~surveillance, ~~States~~advertising, ~~for~~dissemination ~~many~~ of ~~our~~information ~~products~~and promotion. WeFailure ~~or our distributors may be unable~~ to ~~maintain~~receive ~~regulatory~~necessary ~~qualifications, clearances or~~ approvals in ~~these~~international ~~countries~~jurisdictions oron ~~obtain~~a ~~qualifications,~~timely ~~clearances~~basis, or ~~approvals~~at inall, ~~other~~could ~~countries.~~harm ~~If we are not successful in doing so,~~ our business and ~~financial~~operating ~~condition~~results. ~~will~~In beaddition, ~~harmed.~~

~~If our products cause or contribute to a death or a serious injury, we may face voluntary corrective actions, agency enforcement actions and harm to our results.~~28

~~Under the U.S. FDA~~ regulations, weand ~~are~~requirements ~~required to provide the FDA with a Medical Device Report (MDR)~~ for ~~any~~approvals ~~incident~~vary inby ~~which~~country, ~~our product may have caused or contributed to a death or serious injury or in~~ which ~~our~~can ~~product~~significantly ~~malfunctioned~~increase ~~and, if~~ the ~~malfunction~~costs ~~were~~ to recur, would likely cause or contribute to death or serious injury. In addition, all manufacturers placing medical devices in international markets, such as European Union and Asian markets, are legally bound to report any serious or potentially serious incidents involving devices they produce or sell toour ~~the~~products ~~relevant authority~~ in ~~the~~these ~~jurisdiction~~international ~~where the incident occurred~~jurisdictions. Any ~~adverse~~failure ~~event~~to ~~involving~~comply ~~our~~with ~~products,~~applicable ~~including~~legal ~~those~~and ~~requiring~~regulatory anobligations ~~MDR,~~ could result in ~~future~~fines ~~voluntary~~and ~~corrective actions~~penalties, ~~such~~restrictions ason ~~product~~certain ~~actions~~business ~~or customer notifications~~activities, orand ~~agency actions, such as inspection, mandatory recall, or~~ other ~~enforcement~~remedial ~~action. Any corrective action~~measures, ~~whether~~which ~~voluntary~~if ~~or involuntary~~significant, ascould ~~well~~disrupt ~~as defending ourselves in a lawsuit, will require the dedication of~~ our ~~time and capital~~operations, distract management ~~from operating our business~~, and ~~may~~ harm our ~~reputation and financial results~~business.

~~The~~Regulatory ~~decision~~issues tomay ~~file~~adversely an MDR involves a judgment by us as the manufacturer. We have made decisions that certain types of events are not reportable to the FDA or other regulatory bodies; however, there can be no assurance that the FDA or other regulatory bodies will agree with our decisions. If we fail to report adverse events to the FDA or other regulatory bodies within the required timeframes, or at all, or if the FDA or other regulatory bodies disagree with any of our determinations regarding the reportability of certain events, the FDA or other regulatory bodies could take enforcement actions against us, which could have an adverse impact on our ~~reputation and financial results~~operations.

If we ~~modify~~cannot ~~our~~maintain ~~products~~compliance with a particular jurisdiction’s regulatory requirements, weit ~~may~~could adversely impact our financial performance and have a material adverse effect on our ongoing business and operations. We plan to ~~obtain~~remain ~~new~~in ~~marketing~~compliance ~~clearances~~with orregulatory ~~approvals~~requirements orestablished ~~may~~by ~~have~~applicable global regulatory agencies, however, there can be no guarantee that we will do so. We expect to ~~cease~~continue ~~marketing~~to ordevote ~~recall~~resources and attention to our quality systems and compliance and other regulatory requirements as part of the ~~modified~~ordinary ~~products~~course ~~until~~of ~~clearances~~business. We cannot ensure that our efforts will be successful and failure to achieve or ~~approvals~~maintain ~~are~~compliance ~~obtained~~may materially and adversely impact our business and operations.

~~Our~~Laws ~~ICL~~pertaining ~~products are Class III devices subject~~ to ~~the~~healthcare ~~PMA~~fraud approval process in the United States. Any significant modification to a PMA approved device, including modifications to the manufacturing process, labeling or design, requires a PMA Supplement. U.S. FDA guidelines establish different types of PMA Supplements depending on the type of modification, with different data and ~~information~~abuse ~~requirements and different timelines for FDA review and approval. If we modify our ICL products in a way that requires a PMA Supplement, it~~ could ~~require~~materially aadversely ~~lengthy~~affect ~~and expensive review process with the FDA. Further, the FDA may not agree with~~ our ~~decisions regarding whether a new approval is necessary~~business, orfinancial ~~what type of PMA Supplement may be required. In the past~~condition, ~~we have modified some of our 510(k) cleared~~ and ~~PMA~~results ~~approved products and have determined based on our review~~ of ~~the applicable FDA guidance that in certain instances new clearances or approvals were not required~~operations. ~~If the FDA were to disagree with our determination and require us to submit new clearances or approvals, we could be required to cease marketing and/or~~

28Our relationships with physicians, and other healthcare providers are subject to scrutiny under various U.S. and international bribery, fraud and abuse, anti-kickback, false claims, privacy, and similar laws, collectively referred to as “healthcare compliance laws.” Healthcare compliance laws are broad, sometimes ambiguous, complex, and subject to change and changing interpretations, which could restrict our sales or marketing practices. Possible sanctions for violation of these healthcare compliance laws include fines, civil and criminal penalties, exclusion from government healthcare programs, and despite our compliance efforts, we face the risk of an enforcement activity or a finding of a violation of these laws. For example, in 2022 a Japanese trade association (Japan Fair Trade Council of the Medical Devices Industry) ruled that our subsidiary in Japan improperly implemented a program with surgeons and hospitals to obtain videos of cataract surgeries where our cataract intraocular lenses were used.

We have entered into a variety of agreements with healthcare professionals. We have also adopted a Code of Business Conduct and Ethics as well as a Compliance Program for Interactions with Healthcare Professionals which govern our relationships with healthcare professionals to ~~recall~~bolster ~~the~~our ~~modified~~compliance ~~product~~with ~~until~~healthcare compliance laws. While our relationships with healthcare professionals are structured to comply with applicable laws and we ~~obtain~~provide ~~clearance~~training on these laws and our Code and Program, it is possible that enforcement authorities may view our relationships as prohibited arrangements that must be restructured or ~~approval~~for which we would be subject to other significant civil or criminal penalties or debarment. In any event, any enforcement review of or action against us as a result of such review, regardless of outcome, could be costly and time consuming. Additionally, we cannot predict the impact of any changes in or interpretations of these laws. If our operations are found to be in violation of any of the laws described above or any other governmental regulations that apply to us now or in the future, we may be subject to ~~significant~~penalties, ~~regulatory~~including ~~fines~~civil orand criminal penalties, damages, fines, and disgorgement, any of which could adversely affect our ability to operate our business and our financial results.

Regulatory agencies in other countries similarly require approval or clearance prior to our marketing or selling products in those countries. We rely on our distributors to obtain regulatory clearances or approvals of our products in certain countries outside of the United States. If we orrecall ~~our~~a ~~distributors are unable to obtain additional clearances or approvals needed to market existing products~~product, ~~new products or modified products in~~ the ~~United~~cost ~~States~~and ordamage ~~elsewhere~~to ~~or obtain these clearances or approvals in a timely fashion or at all, or if~~ our ~~existing~~reputation ~~clearances~~could orharm ~~approvals are revoked or restricted,~~ our ~~revenues and profitability may decline~~business.

~~Non-compliance~~We ~~with~~have ~~anti-corruption~~voluntarily ~~laws~~recalled our products in the past and recalls could ~~lead~~take place again. We may also be subject to ~~penalties~~recalls initiated by manufacturers of products we distribute. We cannot eliminate the risk of a material recall in the future. Recalls can result in lost sales of the recalled products themselves and can result in further lost sales while replacement products are manufactured, especially if the replacements must be redesigned or ~~harm~~approved by regulatory authorities prior to distribution. If recalled products have already been implanted, we may bear some or all of the cost of corrective surgery. Recalls may also damage our professional reputation and the reputation of our products. The inconvenience caused by recalls and related interruptions in supply, the underlying causal issues, and the damage to our reputation, could cause professionals to discontinue using our products.

WeCompanies are ~~subject~~required to ~~anti-corruption~~maintain ~~laws~~certain inrecords ~~the~~of ~~jurisdictions~~actions, ineven ~~which~~if wethey ~~operate,~~determine ~~including~~such actions are not reportable to the U.S. ~~Foreign~~FDA ~~Corrupt~~or ~~Practices~~other ~~Act~~regulatory ~~(FCPA)~~bodies. ~~Any~~If ~~failure~~we todetermine ~~comply~~that ~~with~~certain ~~these~~actions ~~laws,~~do ~~even~~not ifrequire ~~inadvertent,~~notification ~~could~~of ~~result~~the inFDA ~~significant penalties~~ or ~~otherwise harm our reputation~~others, ~~business,~~the ~~financial~~FDA ~~condition~~or ~~and~~other ~~results~~regulatory ofbodies ~~operations.~~may ~~Our~~disagree ~~reliance~~with onour ~~foreign~~determinations ~~subsidiaries~~ and ~~independent~~require ~~distributors~~us ~~requires~~to ~~vigilance~~report inthose ~~maintaining~~actions ~~our~~as ~~policy~~recalls. ~~against~~In ~~participation~~addition, inthe ~~corrupt~~FDA or ~~non-compliant~~other ~~activity,~~regulatory ~~including,~~bodies ~~for~~could ~~example,~~take ~~with~~enforcement ~~respect~~action tofor ~~our~~failing ~~2022~~to ~~internal~~report ~~review~~the ofrecalls ~~compliance~~when ~~with~~they ~~certain~~were ~~regulations~~conducted inor ~~the~~failing ~~Japanese~~to ~~market~~timely ~~related~~report toor ~~sales~~initiate ofa ~~pre-loaded~~reportable ~~aphakic~~product ~~intraocular~~action. ~~lenses~~Moreover, ~~for~~depending ~~use~~on inthe ~~cataract~~corrective ~~surgery~~action ~~(IOLs,~~we ~~not~~take ~~ICLs).~~to Inredress ~~many~~a ofproduct’s ~~our~~deficiencies ~~markets~~or ~~outside~~defects, the ~~U.S.,~~FDA ~~doctors~~or ~~and~~other ~~hospital~~regulatory ~~administrators~~bodies may berequire, ~~deemed~~or ~~government officials. Despite precautions~~ we may ~~take~~decide, ~~non-compliance may occur~~ that ~~could~~we ~~harm~~will ~~our~~need ~~reputation~~to ~~and~~obtain ~~financial~~new ~~results. Other~~approvals ~~U.S.~~or ~~companies~~clearances infor the ~~medical~~ device ~~and~~before ~~pharmaceutical~~we ~~field~~may ~~have~~market ~~faced~~or ~~criminal~~distribute ~~penalties under~~ the ~~FCPA~~corrected ~~for~~device. ~~allowing~~Seeking ~~their~~such ~~employees~~approvals or ~~agents~~clearances tomay ~~deviate~~delay ~~from~~our ~~appropriate~~ability ~~practices~~to inreplace ~~doing~~the ~~business~~recalled ~~with~~devices ~~such~~in ~~individuals~~a timely manner.

~~Investigations and allegations, whether or not they lead to enforcement action or litigation, can materially harm our business and our reputation.~~29

~~Our~~Changes ~~failure~~in ~~to comply with the requirements of the~~ U.S. FDA or ~~other~~international ~~regulators~~regulations ~~can~~related ~~result in civil and criminal fines, the recall of products, the total or partial suspension of manufacturing or distribution, seizure of products, injunctions, lawsuits, failure~~ to ~~obtain approval of pending~~ product ~~applications~~approval, ~~withdrawal~~including ofthose ~~existing~~that ~~product~~apply ~~approvals~~retroactively, ~~exclusion~~could ~~from~~make ~~participation in government healthcare programs and other sanctions. Any threatened or actual government enforcement action can also generate adverse publicity and require~~ us toless ~~divert~~competitive ~~substantial resources from more productive uses in our business. Enforcement actions could affect our ability to distribute our products commercially~~ and ~~could materially~~ harm our business.

InU.S. ~~addition~~FDA and foreign regulations depend heavily on administrative interpretation, ~~negative~~and ~~publicity~~we ~~about~~cannot ~~investigations~~assure investors that future interpretations made by the FDA or ~~allegations~~other ofregulatory ~~misconduct~~bodies, ~~even~~with ~~without~~possible aretroactive ~~finding~~effect, will not adversely affect us. Additionally, any changes, whether in interpretation or substance, in existing regulations or policies, or any future adoption of ~~misconduct~~new regulations or policies by relevant regulatory bodies, could ~~harm~~rescind, prevent or delay approval of our ~~reputation~~products, ~~with~~which ~~healthcare~~could ~~professionals~~materially impact our competitive position, business, and ~~also~~financial ~~with~~results. Further, we or our distributors have obtained regulatory approvals outside the ~~market~~United States for ~~our~~many ~~common~~of ~~stock~~our products. ~~Responding~~We or our distributors may be unable to ~~investigations~~maintain regulatory qualifications, clearances or ~~conducting~~approvals ~~internal~~in ~~investigations~~these ~~can~~countries beor ~~costly~~obtain qualifications, ~~time-consuming~~clearances, ~~and~~or ~~disruptive~~approvals toin other countries. If we are not successful in doing so, our business and financial condition will be harmed.

~~Risks~~If ~~Related~~our products cause or contribute to ~~Ownership~~a ofdeath ~~Our~~or ~~Common~~a ~~Stock~~serious injury, we may face voluntary corrective actions, agency enforcement actions and harm to our results.

~~The~~Under ~~market~~the ~~price~~U.S. ofFDA regulations, we are required to provide the FDA with a Medical Device Report (MDR) for any incident in which our ~~common~~product ~~stock~~may ~~has~~have ~~been~~caused or contributed to a death or serious injury or in which our product malfunctioned and, ~~will~~if the malfunction were to recur, would likely ~~continue~~cause or contribute to bedeath ~~volatile~~or serious injury. In addition, all manufacturers placing medical devices in international markets, such as the European Union and Asian markets, are legally bound to report any serious or potentially serious incidents involving devices they produce or sell to the relevant authority in the jurisdiction where the incident occurred. Any adverse event involving our products, including those requiring an MDR, could result in future voluntary corrective actions, such as product actions or customer notifications, or agency actions, such as inspection, mandatory recall, or other enforcement action. Any corrective action, whether voluntary or involuntary, as well as defending ourselves in a lawsuit, will require the dedication of our time and capital, distract management from operating our business, and may harm our reputation and financial results.

The ~~market~~decision ~~price~~to ~~for~~file ~~our~~an ~~common~~MDR ~~stock~~involves ~~has~~a ~~fluctuated~~judgment ~~widely.~~by ~~The~~us ~~closing~~as ~~price~~the ~~of our common stock ranged from $23~~manufacturer.93 toWe ~~$52.25~~have ~~per~~made ~~share~~decisions ~~during~~that ~~the~~certain ~~year~~types ~~ended~~of ~~December~~events ~~27,~~are ~~2024.~~not ~~Our~~reportable ~~stock price could continue~~ to ~~experience~~the ~~significant~~FDA ~~fluctuations~~or inother ~~response~~regulatory tobodies; ~~factors such as market perceptions~~however, ~~quarterly~~there ~~variations~~can inbe ~~operating~~no ~~results,~~assurance ~~operating results~~ that ~~vary from~~ the ~~expectations~~FDA ofor ~~securities~~other ~~analysts~~regulatory ~~and~~bodies ~~investors,~~will ~~changes~~agree inwith ~~financial~~our ~~estimates,~~decisions. ~~changes~~If inwe ~~the~~fail ~~business~~to ~~and~~report ~~market~~adverse ~~valuations~~events ofto ~~competitors,~~the ~~announcements~~FDA ~~by us~~ or ~~our~~other ~~competitors~~regulatory ofbodies awithin ~~material~~the ~~nature~~required timeframes, ~~additions~~ or ~~departures~~at ~~of key personnel~~all, ~~future~~or ~~sales~~if ofthe ~~our~~FDA ~~common~~or ~~stock~~other ~~and~~regulatory ~~stock~~bodies ~~volume~~disagree ~~fluctuations.~~with ~~Also,~~any ~~general~~of ~~political~~our ~~and~~determinations ~~economic~~regarding ~~conditions~~the ~~such~~reportability asof acertain ~~recession or interest rate fluctuations~~events, ~~public~~the ~~health~~FDA ~~crises, geopolitical tensions~~ or ~~conflicts,~~other ~~may~~regulatory ~~adversely~~bodies ~~affect~~could ~~the~~take ~~stock~~enforcement ~~market~~actions inagainst ~~general~~us, ~~and,~~which incould ~~turn,~~have ~~the~~an ~~market~~adverse ~~price~~impact ofon our ~~common~~reputation ~~stock~~and financial results.

~~Because~~If we domodify ~~not~~our ~~intend~~products, we may have to ~~pay~~obtain ~~dividends,~~new ~~stockholders~~marketing ~~will~~clearances ~~benefit~~or ~~from~~approvals anor ~~investment~~may inhave ~~our~~to ~~common~~cease ~~stock~~marketing ~~only~~or ifrecall itthe ~~appreciates~~modified inproducts ~~value~~until clearances or approvals are obtained.

WeOur ~~have~~ICL ~~not~~products ~~paid~~are ~~any~~Class ~~cash~~III ~~dividends~~devices onsubject ~~our~~to ~~common~~the ~~stock~~PMA ~~since~~approval ~~our~~process ~~inception~~in the United States. WeAny ~~currently~~significant ~~expect~~modification to ~~retain~~a ~~any~~PMA ~~earnings~~approved ~~for~~device, ~~use~~including modifications to ~~further~~the ~~develop~~manufacturing ~~our~~process, ~~business~~labeling or design, ~~and~~requires doa ~~not~~PMA ~~expect~~Supplement. toU.S. ~~declare~~FDA ~~cash~~guidelines ~~dividends~~establish different types of PMA Supplements depending on the type of modification, with different data and information requirements and different timelines for FDA review and approval. If we modify our ~~common~~ICL ~~stock~~products in ~~the~~a ~~foreseeable~~way ~~future.~~that ~~The~~requires ~~declaration~~a PMA Supplement, it could require a lengthy and ~~payment~~expensive ofreview ~~any~~process ~~such~~with ~~dividends~~the inFDA. Further, the ~~future~~FDA ~~depends~~may ~~upon~~not agree with our ~~earnings,~~decisions ~~financial~~regarding ~~condition~~whether a new approval is necessary, ~~capital~~or ~~needs~~what type of PMA Supplement may be required. In the past, we have modified some of our 510(k) cleared and ~~other~~PMA ~~factors~~approved ~~deemed~~products ~~relevant~~and byhave determined based on our ~~Board~~review of ~~Directors,~~the ~~and~~applicable ~~may~~FDA beguidance ~~restricted~~that byin ~~future~~certain ~~agreements~~instances ~~with~~new ~~lenders~~clearances or approvals were not required. AsIf athe ~~result~~FDA were to disagree with our determination and require us to submit new clearances or approvals, we could be required to cease marketing and/or to recall the ~~success~~modified ofproduct anuntil ~~investment~~we inobtain ~~our~~clearance ~~common~~or ~~stock~~approval, ~~will~~and ~~depend~~we ~~entirely~~may be subject to significant regulatory fines or penalties.

29Regulatory agencies in other countries similarly require approval or clearance prior to our marketing or selling products in those countries. We rely on our distributors to obtain regulatory clearances or approvals of our products in certain countries outside of the United States. If we or our distributors are unable to obtain additional clearances or approvals needed to market existing products, new products or modified products in the United States or elsewhere or obtain these clearances or approvals in a timely fashion or at all, or if our existing clearances or approvals are revoked or restricted, our revenues and profitability may decline.

~~upon any future appreciation. There is no guarantee that our common stock will appreciate in value or even maintain the price at which stockholders purchase their shares.~~30

~~Our~~Non-compliance ~~Certificate~~with ~~of Incorporation and Bylaws,~~ anti-~~takeover~~corruption ~~provisions~~laws ~~of Delaware law, and contractual provisions~~ could ~~delay~~lead ~~or prevent an acquisition or sale of our Company. Our Certificate of Incorporation empowers our Board~~ to ~~issue~~penalties ~~one~~ or ~~more~~harm ~~series of preferred stock, and to determine the rights of each such series as provided in~~ our ~~Certificate of Incorporation~~reputation. These provisions give our Board the ability to deter, discourage or make more difficult a change in control of our Company, even if such a change in control could be deemed in the interest of our stockholders or if such a change in control would provide our stockholders with a substantial premium for their shares over the then-prevailing market price for our common stock. Our Certificate of Incorporation and Bylaws contain other provisions that could have an anti-takeover effect, including the following:

~~stockholders~~We ~~cannot~~are ~~act~~subject byto ~~consent;~~anti-corruption laws in the jurisdictions in which we operate, including the U.S. Foreign Corrupt Practices Act (FCPA). Any failure to comply with these laws, even if inadvertent, could result in significant penalties or otherwise harm our reputation, business, financial condition and results of operations. Our reliance on foreign subsidiaries and independent distributors requires vigilance in maintaining our policy against participation in corrupt or non-compliant activity, including, for example, with respect to our 2022 internal review of compliance with certain regulations in the Japanese market related to sales of pre-loaded aphakic intraocular lenses for use in cataract surgery (IOLs, not ICLs). In many of our markets outside the U.S., doctors and hospital administrators may be deemed government officials. Despite precautions we may take, non-compliance may occur that could harm our reputation and financial results. Other U.S. companies in the medical device and pharmaceutical field have faced criminal penalties under the FCPA for allowing their employees or agents to deviate from appropriate practices in doing business with such individuals.

~~stockholders~~Investigations ~~cannot~~and ~~fill~~allegations, ~~vacancies~~whether onor not they lead to enforcement action or litigation, can materially harm our ~~Board;~~business and our reputation.

~~certain~~Our ~~provisions,~~failure ~~including~~to ~~those~~comply ~~related~~with tothe ~~changing~~requirements of the ~~number~~U.S. ofFDA ~~directors,~~or ~~limiting~~other ~~our~~regulators ~~stockholders’~~can ~~ability~~result toin ~~fill~~civil ~~vacancies~~and oncriminal ~~our~~fines, ~~Board~~the recall of products, ~~prohibiting~~the ~~stockholder~~total ~~action~~or bypartial ~~written~~suspension ~~consent~~of manufacturing or distribution, ~~and~~seizure ~~amending~~of ~~such~~products, ~~provisions~~injunctions, ~~cannot~~lawsuits, befailure ~~altered~~to obtain approval of pending product applications, ~~amended~~withdrawal orof ~~repealed~~existing product approvals, exclusion from participation in government healthcare programs and ~~provisions~~other ~~inconsistent~~sanctions. ~~therewith~~Any ~~cannot~~threatened beor ~~adopted,~~actual ~~without~~government ~~the~~enforcement ~~affirmative~~action ~~vote~~can ofalso ~~holders~~generate ofadverse atpublicity ~~least~~and ~~two-thirds~~require inus ~~voting~~to ~~power~~divert ofsubstantial resources from more productive uses in our ~~outstanding~~business. ~~shares~~Enforcement ofactions ~~common~~could ~~stock~~affect ~~entitled~~our ability to ~~vote~~distribute ~~thereon;~~our products commercially and could materially harm our business.

~~stockholders~~In ~~must~~addition, ~~give~~negative ~~advance~~publicity ~~notice~~about toinvestigations ~~nominate~~or ~~directors~~allegations of misconduct, even without a finding of misconduct, could harm our reputation with healthcare professionals and also with the market for our common stock. Responding to investigations or ~~propose~~conducting ~~other~~internal investigations can be costly, time-consuming, and disruptive to our business.

InRisks ~~addition,~~Related ~~we are generally subject~~ to ~~the~~Ownership ~~anti-takeover provisions~~ of ~~Section~~Our ~~203~~Common of the Delaware General Corporation Law, which regulates corporate acquisitions. These provisions could discourage potential acquisition proposals and could delay or prevent a change in control transaction. They could also have the effect of discouraging tender offers for our common stock or prevent changes in our management.Stock

~~Ownership~~The market price of our common stock ishas ~~concentrated~~been ~~among~~and awill ~~few~~likely ~~investors,~~continue ~~which may affect the ability of a third party~~ to ~~acquire~~be ~~control of us~~volatile. ~~Substantial sales by such investors could cause our common stock price to decline.~~

~~Our~~The ~~largest~~market ~~investor~~price ~~beneficially~~for ~~owns~~our ~~approximately~~common ~~22%~~stock has fluctuated widely. The closing price of our ~~outstanding~~ common stock, ~~and~~ranged ~~our~~from ~~largest~~$15.09 ~~three~~to ~~investors~~$28.57 ~~beneficially~~per ~~own~~share ~~approximately~~during ~~51%~~the ofyear ~~our~~ended ~~outstanding~~January ~~common~~2, ~~stock~~2026. ~~Two~~Our ofstock ~~our~~price ~~current~~could ~~six~~continue ~~directors~~to ~~were~~experience ~~recommended~~significant byfluctuations ~~investors.~~in ~~The~~response ~~sale~~to offactors asuch ~~substantial~~as ~~number~~market ofperceptions, ~~shares~~quarterly ofvariations ~~our~~in ~~common~~operating ~~stock~~results, byoperating ~~any~~results orthat ~~all~~vary from the expectations of ~~our~~securities ~~largest~~analysts and investors, changes in financial estimates, changes in the business and market valuations of competitors, announcements by us or our ~~other~~competitors ~~stockholders~~of ~~within~~ a ~~short~~material ~~period~~nature, additions or departures of ~~time~~key ~~could~~personnel, ~~cause~~future sales of our common stock ~~price~~and tostock ~~decline~~volume fluctuations. Also, ~~make~~general itpolitical ~~more~~and ~~difficult~~economic ~~for~~conditions ussuch toas ~~raise~~a ~~funds~~recession ~~through~~or ~~future~~interest ~~offerings~~rate offluctuations, ~~our~~public ~~common~~health ~~stock~~crises, geopolitical tensions or ~~acquire~~conflicts, ~~other~~may ~~businesses~~adversely ~~using~~affect the stock market in general, and, in turn, the market price of our common stock ~~as consideration~~.

InBecause ~~addition,~~we ~~having~~do ~~such~~not aintend ~~concentration of ownership may have the effect of making it more difficult for a third party~~ to ~~acquire~~pay dividends, orstockholders ofwill ~~discouraging~~benefit ~~a third party~~ from ~~seeking~~an toinvestment ~~acquire,~~in ~~a majority of~~ our ~~outstanding~~ common stock oronly ~~control~~if ofit ~~our~~appreciates ~~Board,~~in ~~including through a proxy solicitation~~value.

~~Future~~We ~~sales~~have not paid any cash dividends on our common stock since our inception. We currently expect to retain any earnings for use to further develop our business, and do not expect to declare cash dividends on our common stock in the foreseeable future. The declaration and payment of any such dividends in the future depends upon our earnings, financial condition, capital needs, and other factors deemed relevant by our Board of Directors, and may be restricted by future agreements with lenders. As a result, the success of an investment in our common stock ~~could~~will ~~reduce~~depend entirely upon any future appreciation. There is no guarantee that our common stock will appreciate in value or even maintain the price at which stockholders purchase their shares.

WeOur ~~could~~Certificate ~~issue additional shares~~ of ~~common~~Incorporation orand ~~preferred~~Bylaws, ~~stock~~anti-takeover toprovisions ~~raise~~of ~~additional~~Delaware ~~capital~~law, orand ~~for~~contractual ~~other~~provisions ~~corporate~~could ~~purposes~~delay ~~without~~or ~~stockholder~~prevent ~~approval.~~an Inacquisition ~~addition,~~or wesale ~~could~~of ~~designate~~our ~~and~~Company. ~~sell~~Our aCertificate ~~class~~ of ~~preferred~~Incorporation ~~stock~~empowers ~~with preferential rights over~~ our ~~common~~Board ~~stock with respect~~ to ~~dividends~~issue one or ~~other~~more ~~distributions.~~series ~~Also,~~of wepreferred ~~have filed in the past~~stock, and ~~may~~to ~~file~~determine in the ~~future,~~rights aof ~~universal~~each ~~shelf~~such ~~registration~~series ~~statement~~as ~~with~~provided ~~the~~in ~~Securities~~our ~~and~~Certificate ~~Exchange~~of ~~Commission~~Incorporation. toThese ~~cover~~provisions ~~the~~give ~~public offering and sale of~~ our ~~equity~~Board orthe ~~debt~~ability ~~securities.~~to ~~Sales~~deter, ofdiscourage ~~our common~~ or ~~preferred~~make ~~stock~~more ~~under~~difficult ~~the~~a ~~shelf~~change ~~registration or~~ in ~~other~~control ~~transactions could dilute the interest~~ of ~~existing~~our ~~stockholders~~Company, ~~and~~even ~~reduce~~if ~~the~~such ~~market~~a ~~price~~change ofin ~~our~~control ~~common~~could ~~stock.~~be ~~Even~~deemed in the ~~absence~~interest of ~~such~~our ~~sales,~~stockholders ~~the~~or ~~perception~~if ~~among~~such ~~investors~~a ~~that~~change ~~additional~~in ~~sales~~control ofwould ~~equity~~provide ~~securities~~our ~~may~~stockholders ~~take~~with ~~place~~a ~~could~~substantial ~~reduce~~premium ~~the~~for ~~market~~their ~~price~~shares ~~of our common stock.~~

~~ITEM 1B. Unresolved Staff Comments~~31

~~None~~over the then-prevailing market price for our common stock. Our Certificate of Incorporation and Bylaws contain other provisions that could have an anti-takeover effect, including the following:

•

30stockholders cannot act by consent;

•

~~ITEM~~stockholders ~~1C. Cybersecurity~~cannot fill vacancies on our Board;

•

~~Risk~~certain ~~Management~~provisions, including those related to changing the number of directors, limiting our stockholders’ ability to fill vacancies on our Board, prohibiting stockholder action by written consent, and ~~Strategy~~amending such provisions, cannot be altered, amended or repealed, and provisions inconsistent therewith cannot be adopted, without the affirmative vote of holders of at least two-thirds in voting power of our outstanding shares of common stock entitled to vote thereon; and

•

Westockholders ~~have~~must ~~established~~give ~~policies~~advance ~~and~~notice ~~processes~~to ~~for~~nominate ~~assessing,~~directors identifying, and managing material risk from cybersecurity threats, and we have integrated these processes into our overall risk management program. We assess material risks from cybersecurity threats, including any potential unauthorized occurrence on or ~~conducted~~propose ~~through~~other ~~our information systems that may result in adverse effects on the confidentiality, integrity, or availability of our information systems or any information residing therein~~business.

WeIn ~~have~~addition, ~~adopted~~we asare generally subject to the ~~governance~~anti-takeover ~~framework~~provisions ~~for~~of ~~our~~Section ~~cybersecurity~~203 ~~program~~of the ~~National~~Delaware ~~Institute~~General ofCorporation ~~Standards~~Law, ~~and~~which ~~Technology~~regulates ~~(NIST)~~corporate ~~Cybersecurity~~acquisitions. ~~Framework~~These ~~(CSF).~~provisions Wecould ~~use~~discourage ~~this~~potential ~~framework~~acquisition asproposals and could delay or prevent a ~~guide~~change toin ~~help~~control ustransaction. ~~identify,~~They ~~assess,~~could ~~respond~~also ~~to,~~have ~~and~~the ~~manage~~effect ~~cybersecurity~~of ~~risks~~discouraging ~~relevant~~tender tooffers for our ~~business.~~common ~~Our~~stock ~~cybersecurity~~or ~~risk~~prevent ~~management~~changes ~~program~~in ~~includes:~~our management.

~~periodic~~Ownership ~~risk~~of ~~assessments~~our ~~designed~~common tostock ~~help~~is ~~identify~~concentrated ~~material~~among ~~cybersecurity~~a ~~risks~~few investors, which may affect the ability of a third party to ~~our~~acquire ~~critical~~control ~~systems,~~of ~~information,~~us. ~~and~~Substantial ~~our~~sales ~~broader~~by ~~enterprise~~such ~~information~~investors ~~technology~~could ~~(IT)~~cause ~~environment;~~our common stock price to decline.

~~skilled~~Our ~~internal~~largest ~~information~~stockholder, ~~security~~Broadwood, ~~(IS)~~beneficially ~~and~~owns ~~data~~approximately ~~privacy~~31% ~~personnel~~of our outstanding common stock, ~~who~~and ~~support~~our largest five investors beneficially own in the aggregate approximately 66% of our ~~cybersecurity~~outstanding ~~risk~~common ~~assessment~~stock. ~~processes,~~Following the termination of our ~~security~~Merger ~~controls~~Agreement with Alcon, on January 14, 2026, STAAR entered into the Cooperation Agreement with Broadwood, which provided for, among other things, certain governance and ~~our~~leadership ~~response~~changes. In accordance with the Cooperation Agreement, two existing directors resigned from the Board and three new directors designated by Broadwood were elected to ~~cybersecurity~~the ~~incidents;~~Board. Further, STAAR agreed to nominate each of the three new directors for election to the Board at the Company’s 2026 annual meeting of stockholders.

~~external~~The ~~service~~sale ~~providers,~~of ~~where~~a ~~appropriate,~~substantial number of shares of our common stock by Broadwood or any of our other largest investors within a short period of time could cause our common stock price to ~~monitor~~decline, ~~assess~~make it more difficult for us to raise funds through future offerings of our common stock or acquire other businesses using our common stock as consideration. In addition, ~~test~~having such a concentration of ownership may have the effect of making it more difficult for a third party to acquire, or ~~otherwise~~of ~~assist~~discouraging ~~with~~a ~~aspects~~third party from seeking to acquire, a majority of our ~~security~~outstanding ~~controls~~common stock or control of our Board, including through a proxy solicitation. For example, Broadwood publicly opposed the Company’s Merger with Alcon, and toat ~~support~~the ~~risk~~January ~~mitigation~~6, ~~efforts;~~2026, Special Meeting, the Company’s stockholders voted against the Merger. The Merger Agreement was terminated in accordance with its terms effective January 6, 2026.

~~training~~Future ~~for~~sales of our ~~employees~~common onstock ~~cybersecurity~~could ~~awareness~~reduce ~~and~~our ~~the~~stock ~~importance of protecting information assets, including “phishing” tests;~~price.

~~periodic~~We ~~reviews~~could issue additional shares of ~~key~~common ~~cybersecurity~~or ~~policies~~preferred stock to raise additional capital or for other corporate purposes without stockholder approval. In addition, we could designate and ~~updating~~sell asa ~~needed;~~class of preferred stock with preferential rights over our common stock with respect to dividends or other distributions. Also, we have filed in the past, and may file in the future, a universal shelf registration statement with the Securities and Exchange Commission to cover the public offering and sale of our equity or debt securities. Sales of our common or preferred stock under the shelf registration or in other transactions could dilute the interest of existing stockholders and reduce the market price of our common stock. Even in the absence of such sales, the perception among investors that additional sales of equity securities may take place could reduce the market price of our common stock.

informationITEM governance1B. policyUnresolved andStaff a cybersecurity incident response plan that includes procedures for monitoring data use and responding to cybersecurity incidents; andComments

~~a third-party risk management process for service providers, suppliers, and vendors~~None.

BasedITEM on the information available to us as of the date of this Annual Report, we believe that risks from cybersecurity threats, including as a result of any prior cybersecurity incidents, have not materially affected us, including our business strategy, results of operations, or financial condition, and as of the date of this Annual Report, we are not aware of any material risks from cybersecurity threats that are reasonably likely to do so1C. However, we cannot eliminate all risks from cybersecurity threats or provide assurances that the Company will not be materially affected by such risks in the future. Additional information on cybersecurity risks we face can be found in Item 1A, Risk Factors, which should be read in conjunction with the foregoing information.Cybersecurity

~~Governance~~Risk Management and Strategy

~~Our~~We ~~Board~~have ~~considers~~established ~~cybersecurity~~policies ~~risk as part of its risk oversight function~~ and ~~has~~processes ~~delegated~~for ~~oversight~~assessing, ~~of cybersecurity~~identifying, ~~including~~and ~~data~~managing ~~security~~material risk ~~mitigation~~from ~~efforts~~cybersecurity threats, toand ~~the~~we ~~Audit~~have ~~Committee.~~integrated ~~Under~~these ~~the~~processes ~~Audit~~into ~~Committee~~our ~~charter,~~overall ~~the~~risk ~~Audit Committee has responsibility for discussing with~~ management ~~the~~program. ~~Company’s~~We ~~policies~~assess ~~with~~material ~~respect~~risks tofrom ~~risk~~cybersecurity ~~assessment and risk management~~threats, including ~~guidelines~~any ~~and~~potential ~~policies~~unauthorized tooccurrence ~~govern~~on ~~the~~or ~~process~~conducted bythrough ~~which the Company’s exposure to risk is handled.~~

The Audit Committee receives reports from management on the Company’s cybersecurity risks and the Company’s cybersecurity program. In addition, management updates the Audit Committee, as necessary, regarding any material cybersecurity incidents. The Audit Committee regularly updates the Board on such matters ,and the Board also periodically receives presentations from management directly on our cybersecurity risk management.32

~~Our management team is responsible for assessing and managing~~ our ~~material~~information ~~risks~~systems ~~from~~that ~~cybersecurity~~may ~~threats~~result ~~and~~in ~~reporting~~adverse effects on ~~such risks to~~ the ~~Audit Committee. Our management team oversees efforts to prevent~~confidentiality, ~~detect~~integrity, ~~mitigate,~~or ~~and~~availability ~~remediate~~of ~~cybersecurity~~our ~~risks~~information ~~and~~systems ~~incidents~~or ~~through~~any ~~various means, which may include threat briefings from internal personnel and external service providers, as well as alerts and reports produced by security tools deployed in the~~ information ~~technology~~residing ~~environment~~therein.

~~STAAR~~We ~~utilizes~~have ~~internal~~adopted ~~personnel~~as ~~and~~the ~~external~~governance ~~service~~framework ~~providers~~for toour ~~support~~cybersecurity program the ~~Company’s~~National ~~cybersecurity~~Institute ~~efforts.~~of ~~Our~~Standards ~~Chief~~and ~~Information~~Technology ~~Officer~~ (~~CIO~~NIST) ~~leads~~Cybersecurity aFramework ~~team~~(CSF). ofWe ISuse ~~professionals~~this ~~who~~framework ~~have~~as ~~primary~~a ~~responsibility~~guide ~~for~~to ~~our~~help ~~overall~~us ~~cybersecurity~~identify, ~~risk~~assess, ~~management~~respond ~~program~~to, and ~~supervises~~manage ~~both~~cybersecurity risks relevant to our ~~internal~~business. ~~personnel~~Our ~~and~~cybersecurity ~~our~~risk ~~retained~~management ~~external~~program includes:

•

31periodic risk assessments designed to help identify material cybersecurity risks to our critical systems, information, and our broader enterprise information technology (IT) environment;

•

~~cybersecurity~~skilled consultants. Our CIO has over two decades of experience, including experience building IT and IS functions and teams, as well as cybersecurity programs. Our CIO holds an M.B.A. in management, has an audit and accounting background, and serves on the SoCalCIO Board, a Southern California organization developing and supporting local CIOs. The CIO and IS team collaborate closely with STAAR’s legal, privacy, and internal ~~audit~~information ~~functions~~security ~~to address cybersecurity and data privacy risks. The Company’s internal~~ (IS) and data privacy ~~specialists have certifications from various organizations~~personnel, ~~including~~who ~~ISC2~~support ~~(Certified~~our ~~Information~~cybersecurity ~~Security~~risk ~~Systems~~assessment ~~Professional or CISSP)~~processes, ~~Global~~our ~~Information~~security ~~Assurance (GIAC)~~controls, ~~the Computing Technology Industry Association (CompTIA)~~ and ~~International~~our ~~Association~~response ofto ~~Privacy~~cybersecurity ~~Professionals (IAPP).~~incidents;

•

~~ITEM~~external ~~2. Properties~~service providers, where appropriate, to monitor, assess, test, or otherwise assist with aspects of our security controls, and to support risk mitigation efforts;

•

~~Our~~training operations are conducted in leased facilities throughout the world. STAAR maintains operational and administrative facilities in the U.S., Switzerland, and Japan. Our global administrative offices, principal manufacturing, warehouse, and distribution facilities are located in Monrovia, California. We manufacture the raw material for ~~Collamer lenses in~~ our ~~facility~~employees inon ~~Aliso~~cybersecurity ~~Viejo,~~awareness ~~California. STAAR also operates a technology center housing its research~~ and development (R&D) team and labs in Tustin, California. Our corporate headquarters, including our executive offices, our EVO Experience Center, and additional operational facilities, are located in Lake Forest, California. STAAR Surgical AG maintains administrative offices, warehouse and distribution facilities in Nidau and Brügg, Switzerland. We are in the ~~process~~importance of ~~expanding~~protecting ~~our~~information ~~manufacturing capabilities for STAAR’s ICL products in our Nidau~~assets, ~~Switzerland~~including ~~facility.~~“phishing” STAAR Japan maintains administrative offices in Tokyo and Osaka, Japan and a distribution facility in Musashino City, in greater Tokyo, Japan. We also maintain commercial offices in China, Germany, Spain, India, Singapore, and the U.K.tests;

•

Weperiodic ~~believe~~reviews ~~our~~of ~~existing~~key ~~properties~~cybersecurity ~~are well maintained~~policies, ~~in good operating condition~~ and ~~are~~updating ~~adequate to support our present level of operations. We also believe that we could increase capacity~~ as needed. ;

•

~~ITEM~~information ~~3. Legal~~governance ~~Proceedings~~policy and a cybersecurity incident response plan that includes procedures for monitoring data use and responding to cybersecurity incidents; and

•

~~See~~a ~~Note~~third-party 12risk tomanagement ~~the~~process ~~Consolidated Financial Statements in this Annual Report on Form 10-K~~ for ~~information~~service ~~about~~providers, ~~Litigation~~suppliers, and ~~Claims, which is hereby incorporated by reference~~vendors.

~~ITEM~~Based 4on the information available to us as of the date of this Annual Report, we believe that risks from cybersecurity threats, including as a result of any prior cybersecurity incidents, have not materially affected us, including our business strategy, results of operations, or financial condition, and as of the date of this Annual Report, we are not aware of any material risks from cybersecurity threats that are reasonably likely to do so. ~~Mine~~ ~~Safety~~However, ~~Disclosures~~we cannot eliminate all risks from cybersecurity threats or provide assurances that the Company will not be materially affected by such risks in the future. Additional information on cybersecurity risks we face can be found in Item 1A, Risk Factors, which should be read in conjunction with the foregoing information.

~~None.~~Governance

~~PART~~Our IIBoard considers cybersecurity risk as part of its risk oversight function and has delegated oversight of cybersecurity, including data security risk mitigation efforts, to the Audit Committee. Under the Audit Committee charter, the Audit Committee has responsibility for discussing with management the Company’s policies with respect to risk assessment and risk management, including guidelines and policies to govern the process by which the Company’s exposure to risk is handled.

~~ITEM~~The ~~5. Market~~Audit ~~for~~Committee ~~Registrant~~receives reports from management on the Company’s ~~Common~~cybersecurity ~~Equity~~risks and the Company’s cybersecurity program. In addition, ~~Related~~management ~~Stockholder~~updates ~~Matters~~the Audit Committee, as necessary, regarding any material cybersecurity incidents. The Audit Committee regularly updates the Board on such matters ,and ~~Issuer~~the ~~Purchases~~Board ofalso ~~Equity~~periodically ~~Securities~~receives presentations from management directly on our cybersecurity risk management.

~~Market~~Our ~~Information~~management team is responsible for assessing and managing our material risks from cybersecurity threats and reporting on such risks to the Audit Committee. Our management team oversees efforts to prevent, detect, mitigate, and remediate cybersecurity risks and incidents through various means, which may include threat briefings from internal personnel and external service providers, as well as alerts and reports produced by security tools deployed in the information technology environment.

~~Our~~STAAR ~~common~~utilizes ~~stock~~internal ispersonnel ~~traded~~and onexternal service providers to support the ~~Nasdaq~~Company’s ~~Global~~cybersecurity ~~Market~~efforts. Our Chief Information Officer (~~NASDAQ~~CIO) ~~under~~leads a team of IS professionals who have primary responsibility for our overall cybersecurity risk management program and supervises both our internal personnel and our retained external cybersecurity consultants. Our CIO has over two decades of experience, including experience building IT and IS functions and teams, as well as cybersecurity programs. Our CIO holds an M.B.A. in management, has an audit and accounting background, and serves on the ~~symbol~~SoCalCIO ~~“STAA~~Board, a Southern California organization developing and supporting local CIOs.” The CIO and IS team collaborate closely with STAAR’s legal, privacy, and internal audit functions to address cybersecurity and data privacy risks. The Company’s internal IS and data privacy specialists have certifications from various organizations, including ISC2 (Certified Information Security Systems Professional or

~~Holders~~33

AsCISSP), ofGlobal ~~February~~Information ~~18,~~Assurance ~~2025~~(GIAC), ~~there were approximately 245 holders of record of our common stock. The number of beneficial owners of our common stock is substantially greater than~~ the ~~number~~Computing ofTechnology ~~record~~Industry ~~holders,~~Association ~~because~~(CompTIA) aand ~~large~~International ~~portion~~Association of ~~our~~Privacy ~~common~~Professionals ~~stock is held in street name by brokers and other nominees~~(IAPP).

DividendsITEM 2. Properties

Our operations are conducted in leased facilities throughout the world. STAAR maintains operational and administrative facilities in the U.S., Switzerland, and Japan. Our global administrative offices, principal manufacturing, warehouse, and distribution facilities are located in Monrovia, California. We ~~have~~manufacture ~~not~~the ~~paid~~raw ~~any~~material ~~cash~~for ~~dividends~~Collamer onlenses in our ~~common~~facility ~~stock~~in ~~since~~Aliso ~~our~~Viejo, ~~inception~~California. WeSTAAR ~~currently~~also ~~expect~~operates toa ~~retain~~technology ~~any~~center ~~earnings~~housing ~~for~~its ~~use~~research toand ~~further~~development ~~develop~~(R&D) team and labs in Tustin, California. Our corporate headquarters, including our ~~business~~executive offices, our EVO Experience Center, and ~~not~~additional tooperational ~~declare~~facilities, ~~cash~~are ~~dividends~~located in ~~the~~Lake ~~foreseeable~~Forest, ~~future~~California. ~~The~~STAAR ~~declaration~~Surgical AG maintains administrative offices, warehouse and ~~payment~~distribution offacilities ~~any~~in ~~such~~Nidau ~~dividends~~and ~~depends~~Brügg, ~~upon~~Switzerland. We are in the ~~Company~~process of expanding our manufacturing capabilities for STAAR’s ~~earnings,~~ICL ~~financial~~products ~~condition~~in our Nidau, ~~capital~~Switzerland ~~needs~~facility. STAAR Japan maintains administrative offices in Tokyo and Osaka, Japan and ~~other~~a ~~factors~~distribution ~~deemed~~facility ~~relevant~~in byMusashino ~~the~~City, ~~Board~~in ~~and~~greater ~~may~~Tokyo, beJapan. ~~restricted~~We byalso ~~future~~maintain ~~agreements~~commercial ~~with~~offices ~~lenders~~in China, Germany, Spain, India, Singapore, and the U.K.

~~Stock~~We ~~Performance~~believe ~~Graph~~our existing properties are well maintained, in good operating condition and are adequate to support our present level of operations. We also believe that we could increase capacity as needed.

ThisITEM performance3. graphLegal shall not be deemed “filed” for purposes of Section 18 of the Exchange Act or incorporated by reference into any filing of STAAR Surgical Company under the Securities Act or the Exchange Act, except as shall be expressly set forth by specific reference in such filing.Proceedings

~~The~~See ~~following~~Note ~~graph~~13 ~~and~~– ~~table~~Commitments ~~show~~and ~~the~~Contingencies ~~cumulative~~– ~~total~~Litigation ~~stockholder~~and ~~return~~Claims ~~during~~to the ~~last~~Consolidated ~~five~~Financial ~~years~~Statements in ~~(i)~~this ~~our~~Annual ~~common~~Report ~~stock,~~on ~~(ii)~~Form ~~the~~10-K ~~NASDAQ~~for ~~Composite~~information ~~Index~~about Litigation and ~~(iii)~~Claims, ~~the~~which ~~S&P~~is ~~400~~hereby ~~Health~~incorporated ~~Care~~by ~~Index~~reference. ~~The graph assumes that~~

32ITEM 4. Mine Safety Disclosures

~~$100 was invested at the closing price of our common stock on the last trading day of fiscal year 2019 and all dividends (if any) were reinvested~~None. ~~We have never paid dividends on our common stock and have no present plans to do so. Stockholder returns over the indicated period should not be considered indicative of future performance.~~

Total Returns Index for Fiscal Years:	2019		2020		2021		2022		2023		2024
STAAR Surgical Company	$	100.00	$	230.42	$	265.56	$	141.17	$	90.76	$	70.39
The Nasdaq Composite Index		100.00		144.12		176.09		118.80		171.83		227.37
S&P 400 Health Care Index		100.00		131.76		146.72		117.30		117.90		125.56

~~ITEM~~Market ~~6. [Reserved]~~Information

33Our common stock is traded on the Nasdaq Global Market (NASDAQ) under the symbol “STAA.”

~~ITEM 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations~~Holders

~~The~~As ~~following~~of ~~Management’s~~February ~~Discussion~~27, ~~and~~2026, ~~Analysis~~there ofwere ~~Financial~~approximately ~~Condition~~233 ~~and~~holders ~~Results~~ of ~~Operations~~record ~~is intended to promote understanding~~ of our ~~financial~~common ~~condition~~stock. ~~and~~The ~~results~~number of ~~operations.~~beneficial ~~You~~owners ~~should read the following discussion and analysis~~ of our ~~financial~~common ~~condition~~stock ~~and~~is ~~results~~substantially ofgreater ~~operations~~than ~~in conjunction with~~ the ~~Consolidated~~number ~~Financial~~of ~~Statements~~record ~~and~~holders, ~~the~~because Notes to those statements included in this Annual Report. This discussion includes forward-looking statements that involve risks and uncertainties. Our actual results may differ materially from those anticipated in these forward-looking statements as a ~~result~~large portion of ~~numerous~~our ~~factors,~~common ~~including~~stock ~~those~~is ~~described~~held in ~~this~~street ~~Annual~~name ~~Report~~by inbrokers ~~Item~~and ~~1A.~~other ~~“Risk Factors~~nominees.”

~~Overview~~Dividends

~~STAAR~~We ~~Surgical~~have ~~Company~~not ~~designs,~~paid ~~develops,~~any ~~manufactures,~~cash ~~and~~dividends ~~sells~~on ~~implantable~~our ~~lenses~~common ~~for~~stock ~~the~~since ~~eye~~our ~~and~~inception. ~~accessory~~We ~~delivery~~currently ~~systems~~expect ~~used~~ to ~~deliver~~retain ~~the~~any ~~lenses~~earnings ~~into~~for ~~the~~use ~~eye.~~to Wefurther ~~are~~develop ~~the~~our ~~leading~~business ~~manufacturer~~and ofnot ~~phakic~~to ~~implantable~~declare ~~lenses~~cash ~~used~~dividends ~~worldwide~~ in ~~corrective~~the orforeseeable ~~“refractive” surgery~~future. We ~~have~~The ~~been~~declaration ~~dedicated~~and ~~solely~~payment toof ~~ophthalmic~~any ~~surgery~~such ~~for~~dividends ~~over~~depends 40upon ~~years.~~the ~~Our~~Company’s ~~goal~~earnings, isfinancial tocondition, ~~position~~capital ~~our~~needs, ~~refractive lenses throughout the world as primary~~ and ~~premium~~other ~~solutions~~factors ~~for~~deemed ~~patients~~relevant ~~seeking~~by ~~visual~~the ~~freedom~~Board ~~from~~and ~~wearing~~may ~~eyeglasses~~be orrestricted ~~contact~~by ~~lenses~~future ~~while~~agreements ~~achieving~~with ~~excellent visual acuity through refractive vision correction~~lenders.

~~STAAR~~Stock ~~generates~~Performance worldwide revenue almost exclusively from sales of our implantable Collamer lenses, or “ICLs.” Our ICLs are made from Collamer, which is a proprietary collagen copolymer material created and exclusively used by STAAR to make our lenses soft, flexible and biocompatible with the eye. Our ICLs are phakic lenses, meaning that they are implanted into the eye without removing the eye’s natural crystalline lens. This distinguishes an ICL procedure from other refractive procedures, as it does not involve the removal of corneal eye tissue. All of our ICLs are foldable, which allows the surgeon to insert them into the eye through a small incision during minimally invasive surgery. Further, while ICLs are intended to be permanent, our ICLs are reversible lens implants, meaning they can be removed by a doctor if desired. Graph

WeThis ~~market~~performance ~~and~~graph ~~sell~~shall ~~our~~not ~~ICLs~~be ~~for~~deemed ~~refractive surgery to treat myopia (nearsightedness) as our~~ “~~EVO~~filed” ~~family~~for ofpurposes ~~lenses. We believe our EVO lenses are an “Evolution in Visual Freedom” designed to provide premium refractive outcomes while optimizing patient comfort. Our EVO family~~ of ~~lenses~~Section ~~includes~~18 ~~our EVO ICL, EVO+ ICL, and EVO Visian ICL. Our newest offering, EVO Viva, has an extended depth~~ of ~~focus~~the ~~(EDoF)~~Exchange ~~optic,~~Act ~~which~~or isincorporated ~~designed~~by toreference ~~treat~~into ~~myopia~~any ~~with~~filing ~~presbyopia (age-related loss~~ of ~~ability~~STAAR toSurgical ~~focus).~~Company Weunder ~~also~~the ~~market~~Securities ~~and~~Act ~~sell~~or anthe ~~ICL~~Exchange ~~lens to treat hyperopia (farsightedness)~~Act, ~~which~~except weas ~~call~~shall ~~our~~be ~~Visian~~expressly ~~ICL.~~set Weforth ~~make~~by ~~our~~specific ~~ICL~~reference ~~product offerings available~~ in ~~multiple~~such ~~models, powers and lengths, including some with toric ICL (TICL) versions to correct for astigmatism (blurred vision)~~filing. ~~Not all of our products are currently available in all markets where we sell ICLs today.~~

~~STAAR~~The ~~employs~~following agraph ~~commercialization~~and ~~strategy~~table ~~that~~show ~~strives~~the ~~for~~cumulative ~~sustainable,~~total ~~profitable~~stockholder ~~growth.~~return ~~Our~~during ~~growth~~the ~~strategy~~last ~~includes~~five ~~making~~years ~~our~~in ~~complete~~(i) ~~ICL~~our ~~product~~common ~~line~~stock, ~~available~~(ii) inthe ~~our~~NASDAQ ~~existing~~Composite ~~geographic~~Index ~~markets~~ and ~~expanding~~(iii) ~~into~~the ~~attractive~~S&P ~~markets~~400 ~~where~~Health weCare ~~do not sell our products today~~Index. InThe ~~addition,~~graph weassumes ~~are~~that ~~focused~~$100 onwas ~~driving~~invested ~~awareness~~at of the ~~ICL~~closing ~~procedure~~price ~~and the clinical benefits~~ of our ~~ICLs,~~common ~~and~~stock ~~providing~~on ~~surgeon~~the ~~training,~~last ~~support~~trading ~~and~~day ~~education,~~of ~~particularly~~fiscal inyear ~~our~~2020 ~~newer markets. Historically, the Company also manufactured~~ and ~~sold~~all ~~intraocular~~dividends ~~lenses~~ (orif ~~IOLs~~any) ~~for~~were ~~use in surgery to treat cataracts~~reinvested. AsWe ~~the~~have ~~Company~~never ~~has~~paid ~~focused~~dividends ~~its business and strategy~~ on ~~its~~our ~~ICL~~common ~~product~~stock ~~offerings,~~and we have ~~phased~~no ~~out~~present ~~our~~plans ~~cataract~~to ~~IOL~~do ~~product line~~so. ~~For~~Stockholder ~~the~~returns ~~fiscal~~over ~~year~~the ~~ended~~indicated ~~December~~period ~~27,~~should ~~2024,~~not ~~approximately~~be ~~100%~~considered ~~our~~indicative ~~net sales were generated from sales~~ of ~~ICLs~~future performance.

~~Business Environment and Factors Affecting Comparability~~34

~~Given~~Prepared ~~the~~by ~~size~~Zacks ofInvestment ~~the Company’s business in China relative to its net sales in the rest of the world~~Research, ~~macroeconomic conditions in China have a significant impact on the Company’s business, operations, and financial results~~Inc. ~~For~~Used ~~the~~with ~~fiscal year ended December 27, 2024, we reported $313~~Permission.9 ~~million~~All ofrights ~~net sales, a decrease of 3% compared to $322~~reserved.4 million in fiscal 2023, and we incurred a net loss of $20.2 million compared to net income of $21.3 million in fiscal 2023. Prior to fiscal 2024, we had reported over ten years of annual net sales growth, and we had delivered net income profitability since 2018. Our results in fiscal 2024 were negatively impacted by a significant decline in ICL sales in China in the fourth quarter ended December 27, 2024, where the sluggish economy and weak consumer consumption contributed to fluctuating demand for ICL procedures.

During the fourth quarter ended December 27, 2024, we shipped a $27.5 million order of ICLs to one of our distributors in China. After the shipment was received, the distributor raised concerns about the ongoing fluctuations in procedural volumes in China and forecasted demand for fiscal 2025. Following discussions with the distributor, the distributor requested extended payment terms for the order, and we agreed. From time to time, we agree to extended


Total Returns Index for Fiscal Years:	2020		2021		2022		2023		2024		2025
STAAR Surgical Company	$	100.00	$	115.25	$	61.26	$	39.39	$	30.55	$	29.78
The Nasdaq Composite Index		100.00		122.18		82.43		119.22		157.76		187.09
S&P 400 Health Care Index		100.00		111.35		89.02		89.48		95.30		99.76

3435

paymentUnregistered termsSales with our distributors, but given that these payment terms were significantly longer than the terms included in our distributor agreement, we determined that under accounting principles generally accepted in the U.S. (“GAAP”), collectability was not probable, and we did not recognize the revenue associated with the shipment in the quarter ended December 27, 2024. As the shipment was received by the distributor, and control of theEquity productSecurities passed to the distributor, the product is no longer recorded in our inventory. Ordinarily, we recognize revenue upon shipment of product, and weUse record cost of sales when we recognize revenue based on the matching principle under GAAP. In this instance, we did not recognize the revenue, but we did recognize costs of sales associated with this order of $3.9 million, which had a negative impact on our gross profit and gross profit margin for the fourth quarter and fiscal year ended December 27, 2024. As the control of the inventory transferred to the distributor, accounting rules require us to record the costs of sales upon such transfer, even if revenue is not recognized until a future period. Proceeds

~~Under~~The ~~the~~following ~~extended~~table ~~payment~~summarizes ~~terms,~~ the ~~distributor~~Company’s ~~agreed~~share torepurchase ~~pay~~activity for the ~~$27.5~~three ~~million~~months order by the end of the quarter ending September 26, 2025. Revenue for the order will not be recognized until payments are received from the distributor, at which point the collectability concern is alleviated. Because the cost of sales associated with this order was recognized in the quarter ended ~~December~~January 272, ~~2024~~2026, ~~there~~on ~~will be no associated cost of sales for this order when the revenue is recognized, resulting in~~ a ~~100%~~monthly gross profit in the period payments are received. While we did not recognize revenue on this order upon shipment, we believe that having these ICLs in-country in China can help address challenges and delays associated with importation and logistics and can mitigate potential impacts from geopolitical risk and tariff changes. basis:

Our agreements with our distributors in China provide for minimum inventory requirements based on forecasted demand. During fiscal 2024, our distributors purchased lenses above such minimums in anticipation of higher procedural volumes during what is typically a summer “high season” in China. Due to dynamic macroeconomic conditions and other factors, the number of ICL procedures performed during the high season and the second half of 2024 overall was lower than expected. Accordingly, our distributors in China held, as of December 27, 2024, elevated levels of ICL product inventory. We believe that volatility in surgical procedure volumes will continue until consumer confidence stabilizes and ultimately improves in China. As a result, we believe that the level of ICL inventory held by our distributors in China is sufficient to meet currently expected procedure volumes for at least the first half of fiscal 2025. We therefore anticipate we will report minimal China ICL sales in the first half of fiscal 2025. As China in-country inventory is reduced during the first half of fiscal 2025, we would expect our China revenue to normalize. However, our ability to successfully address these challenges will depend on a number of factors, including the risk of a prolonged slowdown or disruption in China and the institution of trade tariffs both globally and between the U.S. and China, as set forth in Item 1A. “Risk Factors.”


Period	Total Number of Shares (or Units) Purchased		Average Price Paid per Share (or Unit)		Total Number of Shares Purchased as Part of Publicly Announced Plans or Programs		Maximum Number (or Approximate Dollar Value) of Shares that may yet to be Purchased Under the Plans or Programs (in thousands)(1)
September 27 - October 24, 2025		—	$	—		—	$	23,539
October 25 - November 21, 2025		—		—		—		23,539
November 22 - January 2, 2026		—		—		—		23,539
Total		—				—

(1)

~~During~~On ~~fiscal~~May 16, 2025, wethe ~~will~~Company ~~continue~~announced tothat ~~assess~~its ~~appropriate~~Board ~~inventory~~of ~~levels,~~Directors ~~both~~authorized ~~inventory~~a ~~held~~share byrepurchase usprogram ~~and~~under ~~inventory~~which ~~held~~the byCompany ~~our~~may ~~distributors.~~repurchase Weup ~~generally~~to ~~keep~~$30 ~~sufficient~~million ~~inventory~~of onits ~~hand~~outstanding tocommon ~~ship~~stock. ~~product~~During ~~immediately~~the orthree ~~shortly~~months ~~after~~ended ~~receipt~~January of2, an2026 ~~order~~the Company did not purchase shares. InAs ~~addition~~of January 2, ~~our~~2026, ~~distributors~~approximately ~~hold~~$23.5 ~~their~~million ~~own~~remained ~~inventory~~available ~~in-country~~for ~~based~~repurchases onpursuant ~~forecasted~~to ~~demand~~our share repurchase program. ~~During~~Under ~~fiscal~~the ~~2024,~~share werepurchase ~~increased~~program, ~~our~~the ~~inventory~~Company ~~levels~~may torepurchase ~~meet~~shares in the ~~significant~~open ~~level~~market, ofthrough ~~anticipated~~privately ~~demand~~negotiated ~~for~~transactions, ~~our~~by ~~ICL~~entering ~~lenses~~into structured repurchase agreements with third parties, toby ~~support~~making ~~quick~~block purchases, and/or ~~efficient~~pursuant ~~delivery~~to ~~and~~Rule ~~fulfillment~~10b5-1 ~~for~~trading ~~surgical~~plans. ~~procedures~~The timing, manner, price, and toamount ~~mitigate~~of ~~risks~~any ~~associated~~repurchases ~~with~~under ~~potential~~the ~~disruptions~~program will be determined by the Company in its discretion, subject to ~~our~~market ~~manufacturing~~conditions, legal requirements, and ~~production~~other ~~process~~considerations. ~~During~~The ~~fiscal~~Company ~~2025,~~is wenot ~~expect~~obligated to ~~adjust~~repurchase ~~our~~any ~~production~~specific ~~output~~number ~~based~~of onshares, ~~forecasted demand~~ and ~~optimize~~ the ~~level~~program ofmay ~~inventory~~be ~~held~~modified, bysuspended, usor ~~and~~discontinued ~~held~~at byany ~~our~~time, ~~distributors~~without prior notice.

SeeITEM Item 16. “Business,” for a discussion of:[Reserved]

~~Operations~~36

PrincipalITEM Products7. Management’s Discussion and Analysis of Financial Condition and Results of Operations

~~Distribution~~The following Management’s Discussion and ~~Customers~~Analysis of Financial Condition and Results of Operations is intended to promote understanding of our financial condition and results of operations. You should read the following discussion and analysis of our financial condition and results of operations in conjunction with the Consolidated Financial Statements and the Notes to those statements included in this Annual Report. This discussion includes forward-looking statements that involve risks and uncertainties. Our actual results may differ materially from those anticipated in these forward-looking statements as a result of numerous factors, including those described in this Annual Report in Item 1A. “Risk Factors.”

~~Competition~~Overview

~~Regulatory~~STAAR ~~Matters~~Surgical Company designs, develops, manufactures, and sells implantable lenses for the eye and accessory delivery systems used to deliver the lenses into the eye. We are the leading manufacturer of phakic implantable lenses used worldwide in corrective or “refractive” surgery. We have been dedicated solely to ophthalmic surgery for over 40 years. Our goal is to position our refractive lenses throughout the world as primary and premium solutions for patients seeking visual freedom from wearing eyeglasses or contact lenses while achieving excellent visual acuity through refractive vision correction.

~~Research~~STAAR generates worldwide revenue almost exclusively from sales of our Implantable Collamer Lenses, or “ICLs.” Our ICLs are made from Collamer, which is a proprietary collagen copolymer material created and ~~Development~~exclusively used by STAAR to make our lenses soft, flexible and biocompatible with the eye. Our ICLs are phakic lenses, meaning that they are implanted into the eye without removing the eye’s natural crystalline lens. This distinguishes an ICL procedure from other refractive procedures, as it does not involve the removal of corneal eye tissue. All of our ICLs are foldable, which allows the surgeon to insert them into the eye through a small incision during minimally invasive surgery. Further, while ICLs are intended to be permanent, our ICLs are reversible lens implants, meaning they can be removed by a doctor if desired.

~~Strategic~~We ~~Imperatives~~market and sell our ICLs for ~~2025~~refractive surgery to treat myopia (nearsightedness) as our “EVO” family of lenses. We believe our EVO lenses are an “Evolution in Visual Freedom” designed to provide premium refractive outcomes while optimizing patient comfort. Our EVO family of lenses includes our EVO ICL, EVO+ ICL, and EVO Visian ICL. Our newest offering, EVO Viva, has an extended depth of focus (EDoF) optic, which is designed to treat myopia with presbyopia (age-related loss of ability to focus). We also market and sell an ICL lens to treat hyperopia (farsightedness), which we call our Visian ICL. We make our ICL product offerings available in multiple models, powers and lengths, including some with toric ICL (TICL) versions to correct for astigmatism (blurred vision). Not all of our products are currently available in all markets where we sell ICLs today.

WeSTAAR ~~believe~~employs wea ~~have~~commercialization astrategy ~~significant~~that ~~opportunity~~strives tofor ~~fundamentally~~sustainable, ~~transform~~profitable ~~how~~growth. ~~myopia~~Our growth strategy includes making our complete ICL product line available in our existing geographic markets and ~~other~~expanding ~~refractive~~into ~~conditions~~attractive ~~are~~markets ~~treated~~where we do not sell our products today. We ~~want~~In toaddition, bewe are focused on driving awareness of the ~~first~~ICL ~~choice~~procedure ~~for~~and ~~doctors~~the clinical benefits of our ICLs, and ~~for~~providing ~~patients~~surgeon ~~seeking~~training, ~~visual~~support ~~freedom~~and ~~from~~education, ~~wearing~~particularly ~~eyeglasses~~in orour ~~contact~~newer ~~lenses~~markets. AHistorically, ~~key~~the ~~focus~~Company inalso ~~2025~~manufactured ~~will~~and besold ~~supporting~~intraocular ~~our~~lenses ~~business~~(or inIOLs) ~~China~~for asuse wein ~~work~~surgery to ~~navigate~~treat cataracts. As the ~~macroeconomic~~Company ~~challenges~~has focused its business and ~~position~~strategy ~~the~~on ~~Company~~its ~~for~~ICL ~~growth~~product ~~once~~offerings, ~~the~~we ~~market~~have ~~recovers.~~phased ~~Across~~out our ~~markets~~cataract IOL product line. For the fiscal year ended January 2, we2026, approximately 100% our net sales were generated from sales of ICLs.

35Termination of Alcon Merger Agreement

~~recognize~~As previously disclosed, on August 4, 2025, STAAR entered into an Agreement and Plan of Merger (the ~~need~~“Merger toAgreement”) ~~further~~with ~~educate~~Alcon Research, LLC, a Delaware limited liability company (“Alcon”), and ~~train~~Rascasse ~~ophthalmic~~Merger ~~surgeons~~Sub, ~~about~~Inc., ~~our~~a ~~ICLs~~Delaware corporation and ~~our~~a ~~ICL~~wholly ~~procedure~~owned direct subsidiary of Alcon (“Merger Sub”). InThe ~~2025~~Merger Agreement provided, weamong ~~intend~~other tothings, ~~increase~~that subject to the ~~number~~satisfaction or waiver of ~~strategic~~the ~~collaborations~~conditions ~~with~~set ~~leading~~forth ~~refractive~~therein, ~~surgeons~~Merger Sub will merge with and ~~practices~~into inthe Company (the ~~U.S.~~“Merger”), towith ~~collaborate~~the onCompany ~~marketing,~~surviving ~~training~~the ~~and~~Merger ~~education~~as ~~activities.~~a Wewholly ~~also~~owned ~~plan~~subsidiary toof ~~leverage~~Alcon. ~~our~~The ~~new~~Company ~~EVO~~and ~~Experience~~Alcon ~~Center~~entered atinto ~~our~~two ~~headquarters~~amendments into ~~Lake~~the ~~Forest~~Merger Agreement, CAon November 7, to2025 ~~conduct~~and ~~additional~~December ~~hands-on~~9, ~~training~~2025, and ~~education~~the inCompany ~~lens-based~~held ~~vision~~a ~~correction.~~special Inmeeting ~~addition,~~of westockholders ~~are~~(the ~~continuing~~“Special Meeting”) to ~~invest~~vote inon ~~enhanced~~the ~~systems~~Merger ~~and~~on ~~tools~~January to6, ~~make~~2026. ~~ordering~~At ~~and~~the ~~fulfillment~~Special ~~faster~~Meeting, the Company’s stockholders voted against the Merger, and ~~easier~~the Merger Agreement was terminated in accordance with its terms effective January 6, 2026. InNone ~~2025~~of the Company, weAlcon ~~will~~or ~~also~~Merger ~~continue~~Sub was required to ~~drive~~pay ~~awareness~~any termination fee as a result of the ~~ICL~~termination ~~procedure~~of tothe ~~reach~~Merger ~~even~~Agreement, ~~more~~and ~~potential~~the ~~patients~~parties are responsible for their respective costs and ~~effectively~~expenses ~~communicate~~related to the ~~clinical~~Merger ~~benefits~~Agreement ofand ~~our~~the ~~ICLs~~transactions contemplated thereby. ~~While~~During fiscal 2025, we ~~work~~incurred to$17.1 ~~launch~~million ~~our~~in ~~existing~~professional ~~product~~fees ~~portfolio~~and inexpenses ~~attractive~~related ~~global~~to ~~markets~~the Merger, wewhich ~~also~~are ~~intend~~recorded toas ~~continue~~Merger totransaction ~~invest~~and inrelated ~~product~~costs ~~innovation~~on inthe ~~2025.~~Consolidated

~~Results of Operations~~37

Statement of Operations. Following the termination of the Merger Agreement, on January 14, 2026, STAAR entered into a letter agreement (the “Cooperation Agreement”) with Broadwood Partners, L.P. and its affiliates (“Broadwood”), the Company’s largest stockholder. The ~~following~~Cooperation ~~table~~Agreement ~~sets~~provided ~~forth~~for certain governance and leadership changes, as well as reimbursement by the ~~percentage~~Company of ~~total~~approximately ~~sales~~$7.0 ~~represented~~million in expenses incurred by ~~certain~~Broadwood ~~items~~and ~~reflected~~other stockholders in connection with their engagement with the Company’s, ~~Consolidated~~including ~~Statement~~the Special Meeting. See Note 1 – Organization and Description of ~~Operations~~Business and Accounting Policies – Termination of Alcon Merger Agreement and Note 19 – Subsequent Events to the Consolidated Financial Statements for information about the ~~period~~Merger ~~indicated~~Agreement and the Cooperation Agreement.

	Percentage of Net Sales
	2024			2023			2022
Net sales		100.0	%		100.0	%		100.0	%
Cost of sales		23.7	%		21.6	%		21.5	%
Gross profit		76.3	%		78.4	%		78.5	%
General and administrative		28.6	%		22.4	%		19.2	%
Selling and marketing		34.5	%		33.4	%		31.2	%
Research and development		17.2	%		13.8	%		12.7	%
Total selling, general and administrative		80.3	%		69.6	%		63.1	%
Operating income (loss)		(4.0	)%		8.8	%		15.4	%
Total other income, net		1.0	%		1.7	%		0.6	%
Income (loss) before income taxes		(3.0	)%		10.5	%		16.0	%
Provision for income taxes		3.6	%		3.8	%		2.1	%
Net income (loss)		(6.6	)%		6.7	%		13.9	%

Business Environment and Factors Affecting Comparability

~~Net~~Given ~~Sales~~ the size of the Company’s business in China relative to its net sales in the rest of the world, macroeconomic conditions in China have a significant impact on the Company’s business, operations, and financial results. We reported net sales of $239.4 million, $313.9 million, and $322.4 million for fiscal years 2025, 2024, and 2023, respectively. The significant decreases in net sales were primarily due to the dynamics within our business in China where the continued sluggish economy and weak consumer consumption contributed to fluctuating demand for ICL procedures. We incurred net losses of $80.4 million and $20.2 million for fiscal years 2025 and 2024, respectively. Prior to fiscal 2024, we had reported over ten years of annual net sales growth, and we had delivered net income profitability since 2018.

~~The~~Aggregate ~~following~~net ~~table~~sales ~~presents~~to our ~~net~~two ~~sales~~distributors in China were $77.8 million for fiscal year 2025, bycompared ~~product~~to $162.3 million for fiscal year 2024. China net sales for fiscal year 2025 included $27.5 million related to the previously disclosed December 2024 ICL shipment that was subject to extended payment terms, and which was paid in full in fiscal ~~years~~2025 ~~presented~~pursuant to such payment terms (~~dollars~~the in“December ~~thousands~~China Shipment”):. As previously disclosed, we shipped $27.5 million of ICLs in December 2024 to one of our distributors in China for which the distributor requested extended payment terms through September 2025. Given the extended payment terms, net sales for the shipment were not recognized by us until payments were received. As the cost of sales associated with the December China Shipment was recognized in December 2024, the payments, when made, were recognized at 100% gross margin in the applicable quarter.

	2024					2023					2022
	% of Total			Sales		% of Total			Sales		% of Total			Sales
ICLs		99.6	%	$	312,543		99.1	%	$	319,427		94.8	%	$	269,712
Other product sales
Cataract IOLs		0.0	%		—		0.3	%		1,139		3.4	%		9,638
Other surgical products		0.4	%		1,358		0.6	%		1,849		1.8	%		5,041
Total other product sales		0.4	%		1,358		0.9	%		2,988		5.2	%		14,679
Net sales		100.0	%	$	313,901		100.0	%	$	322,415		100.0	%	$	284,391

During fiscal 2025, our distributors in China purchased fewer ICLs, as they were able to satisfy procedural demand largely from their existing inventory. Our distributors in China have historically purchased products from us in bulk shipments in advance of anticipated demand, which they use to satisfy orders from hospital customers based on scheduled surgeries. During fiscal 2024, our distributors in China purchased lenses above contracted minimums in anticipation of higher procedural volumes during what is typically a summer “high season” in China. Due to dynamic macroeconomic conditions and other factors, the number of ICL procedures performed during the high season and the second half of 2024 overall was lower than expected. Accordingly, our distributors in China held, as of December 27, 2024, elevated levels of ICL product inventory. The level of inventory owned by our distributors in China has decreased substantially since December 27, 2024, and has returned to contractual levels. As anticipated, we reported lower China ICL sales in fiscal 2025 compared to fiscal 2024.

~~Net~~In ~~sales~~April ~~for~~2025, ~~2024~~in ~~decreased~~response 3%to ~~from~~the ~~2023~~announcement of tariffs by the United States on Chinese goods, China announced retaliatory tariffs on U.S.-origin ~~The~~goods. ~~decrease~~In order to mitigate potential financial exposure from such tariffs, we negotiated and implemented consignment agreements with our two distributors in ~~net~~China, ~~sales~~and ~~was~~we ~~due~~delivered consigned inventory to ~~decreased~~China ~~ICL~~in ~~sales~~advance of ~~$6.9~~the ~~million~~implementation of tariffs and ~~decreased~~delivered ~~other~~additional ~~product~~consignment ~~sales~~inventory throughout fiscal 2025. While the tariff situation is evolving, we believe that these efforts to increase the amount of $1ICLs in China reduce the Company’s tariff risk in China in the near-term.6 ~~million~~In addition, we are rapidly ramping up our production capabilities in Switzerland to supplement our manufacturing capacity in the United States to provide optionality under multiple tariff scenarios.

~~Net~~Given ~~sales~~that ~~for~~we ~~2023~~maintained ~~increased~~consigned ~~13%~~inventory in China in 2025, purchases by our distributors were satisfied in part from ~~2022~~our consigned inventory, rather than through bulk purchases. ~~The~~As ~~increase~~our inChina ~~net~~distributor ~~sales~~inventory ~~was~~levels ~~due~~have normalized, we intend to ~~increased~~reduce ~~ICL~~our ~~sales~~consigned ofinventory ~~$49~~levels in China going forward.7 ~~million~~We reduced our China inventory levels in 2025, ~~partially~~and ~~offset~~we have taken steps to mitigate the risk of elevated inventory buildup by aour ~~decrease~~distributors, while at the same time maintaining sufficient ICL inventory in ~~other~~China ~~product~~to ~~sales~~support ofquick ~~$11.7~~and ~~million.~~efficient delivery and fulfillment for surgical procedures.

~~Total~~In ~~ICL sales for 2024 decreased 2% from 2023~~2025, ~~with~~we ~~units~~expanded ~~down~~our ~~6%.~~manufacturing ~~The~~capabilities ~~sales~~for ~~decrease~~our ~~was~~ICL ~~driven~~products ~~by the APAC region, which decreased 6% with units down 9%. The decrease~~ in ~~the~~our ~~APAC region was driven by decreased sales in China~~Nidau, ~~primarily~~Switzerland ~~related to the $27~~facility.5 ~~million~~As ~~order in December 2024 for which~~ we ~~did~~ramp ~~not~~up ~~recognize~~ICL ~~revenue~~manufacturing ~~discussed above, partially offset by sales growth~~ in ~~India~~Nidau, ~~other APAC Distributors~~Switzerland, ~~Japan~~our ~~and~~costs ~~Korea.~~are ~~The~~expected ~~Europe, Middle East and Africa region sales increased 10% with unit growth up 17%, due primarily~~ to ~~sales increases in our distributor markets. The Americas region sales increased 16%, with unit~~ increase ofgiven ~~17%, due primarily to sales growth in~~ the ~~U.S.~~expense ~~Changes~~of inoperating ~~foreign~~two ~~currency~~sites ~~unfavorably impacted ICL sales by $2.7 million, which impacted our Japan~~ and ~~Europe,~~lower ~~Middle~~site ~~East~~utilization ~~and~~impacts ~~Africa~~cost ~~markets~~absorption. ~~ICL~~The ~~sales~~on-going ~~represented~~operation ~~99.6%~~ of ~~our~~two ~~total~~manufacturing ~~sales for fiscal year 2024.~~

Total ICL sales for 2023 increased 18% from 2022, with unit growth up 19%. The sales increase was driven by the APAC region, which grew 21% with unit growth of 22%, primarily due to sales growth in China, other APAC Distributors, India, Japan and Korea. The Europe, Middle East and Africa region sales increased 7% with units similar to prior year, due to sales growth in our distributor markets and direct markets. The Americas region sales increased 38

36sites will create pressure on gross margins. Over the longer term, as we grow revenue and align sales with manufacturing production, we would expect our gross margin to improve. We also expect the operation of two manufacturing sites will lead to higher inventory levels in the near-term.

~~11%~~During fiscal 2026, ~~with~~we ~~unit~~will ~~increase~~continue ofto 9%assess appropriate inventory levels, ~~due~~both ~~primarily~~inventory held by us and inventory held by our distributors. We generally keep sufficient inventory on hand to ~~sales~~ship ~~growth~~product inimmediately ~~the~~or Ushortly after receipt of an order.S. ~~Changes~~In inaddition, ~~foreign~~our ~~currency~~distributors ~~unfavorably~~hold ~~impacted~~their ~~ICL~~own ~~sales~~inventory byin-country $1based on forecasted demand.8 ~~million~~During fiscal 2026, ~~which~~we ~~impacted~~expect to adjust our ~~Japan~~production ~~and~~output ~~Europe,~~based ~~Middle~~on ~~East~~forecasted demand and ~~Africa~~optimize ~~markets. ICL~~the ~~sales~~level ~~represented~~of ~~99.1%~~inventory ofheld ~~our~~by ~~total~~us ~~sales~~and ~~for~~held ~~fiscal~~by ~~year~~our ~~2023~~distributors.

~~Other~~See ~~product~~Item ~~sales include cataract IOLs, delivery systems and normal recurring sales adjustments such as sales return allowances~~1. As a result of third-party materials and supply chain challenges that affected our cataract IOLs and associated delivery devices, we have phased out sales of our cataract IOLs as we focus on growing our ICL business. During 2023, we stopped manufacturing cataract IOLs, and we did not sell any cataract IOLs in 2024. ~~Other product sales for 2024 decreased 55% from 2023~~“Business,” mainly due to decreased sales of cataract IOLs and cataract IOL injector parts, partially offset by increased sales of delivery systems. Changes in foreign currency unfavorably impacted other product sales by $0.1 million. Other product sales represented less than 1.0% of our total sales for ~~fiscal~~a ~~year~~discussion ~~2024.~~of:

•

Other product sales in 2023 decreased 80% from 2022, mainly due to decreased sales of cataract IOLs and cataract IOL injector parts and increased sales returns reserves related to cataract IOLs. Changes in foreign currency unfavorably impacted other product sales by $0.3 million. Other product sales represented 1.0% of our total sales for fiscal year 2023.Operations

•

~~Gross~~Principal ~~Profit~~ Products

•

~~The~~Distribution ~~following table presents our gross profit~~ and ~~gross profit margin for the fiscal years presented (dollars in thousands):~~Customers

•

										Percentage Change
	2024			2023			2022			2024 vs. 2023			2023 vs. 2022
Gross profit	$	239,582		$	252,651		$	223,383			(5.2	)%		13.1	%
Gross profit margin		76.3	%		78.4	%		78.5	%

Competition

•

~~Gross~~Regulatory profit for 2024 decreased 5.2% from 2023. Gross profit margin decreased to 76.3% of revenue for 2024 compared to 78.4% of revenue for 2023. The decrease in gross profit and gross profit margin was primarily due to the recognition of $3.9 million of cost of sales associated with our shipment of $27.5 million of ICLs to one of our distributors in China in the quarter ended December 27, 2024, for which we did not recognize revenue due to extended payment terms with the distributor. Gross profit and gross profit margin for fiscal 2024 were also negatively impacted by period costs associated with the expansion of the Company’s manufacturing capabilities in its Nidau, Switzerland facility, as well as the temporary idling of its U.S. manufacturing facility during the holiday season and for facility upgrades. Matters

•

~~Gross~~Research ~~profit for 2023 increased 13.1% from 2022. Gross profit margin increased to 78.4% of revenue for 2023 compared to 78.5% of revenue for 2022, due to reserves related to cataract IOLs~~ and ~~increased period costs associated with manufacturing expansion projects, offset by an increased mix of ICL sales, which carry a higher margin.~~Development

~~General~~Strategic ~~and~~Imperatives ~~Administrative~~for ~~Expense~~ 2026

~~The~~We ~~following~~believe ~~table~~we ~~presents~~have ~~our~~a ~~general~~significant opportunity to fundamentally transform how myopia and ~~administrative~~other ~~expense~~refractive ~~for~~conditions are treated. We want to be the ~~fiscal~~first ~~years~~choice ~~presented~~for ~~(dollars~~doctors inand ~~thousands):~~for patients seeking visual freedom from wearing eyeglasses or contact lenses.

										Percentage Change
	2024			2023			2022			2024 vs. 2023			2023 vs. 2022
General and administrative expense	$	89,898		$	72,319		$	54,742			24.3	%		32.1	%
Percentage of sales		28.6	%		22.4	%		19.2	%

The Company is navigating market headwinds, geopolitical factors and a dynamic environment in key regions, including China. In 2026, we are aligned around three focused priorities to allow us to advance around this goal.

~~General~~Focused ~~and~~growth ~~administrative~~– ~~expenses~~we ~~for~~are ~~2024~~focused ~~increased~~on 24revenue growth in our key markets, with a strong emphasis on execution.3% ~~from~~This ~~2023~~includes sharpening commercial focus, ~~due~~prioritizing towhere ~~increased~~we ~~outside~~can ~~services~~win, ~~facilities~~and ~~costs~~improving consistency across markets. Across markets, ~~salary-related~~we ~~and~~intend ~~payroll~~to ~~tax~~maximize ~~expenses~~the ~~and~~impact ~~bonus~~of our strategic customer agreements and ~~stock-based~~develop ~~compensation~~relationships ~~expenses.~~with customers that position EVO ICLs to treat refractive error more broadly.

~~General~~Focused ~~and~~investment ~~administrative~~– ~~expenses~~we ~~for~~believe ~~2023~~growth ~~increased~~must 32be sustainable.1% ~~from~~In ~~2022~~2026, ~~due~~we will continue to ~~increased~~prioritize ~~salary~~investments that support long-~~related~~term value creation, with a clear focus on what drives results and ~~payroll~~expands ~~tax~~profits ~~expenses,~~by ~~outside~~investing ~~services~~wisely in key markets. Across our markets, ~~facilities~~we ~~costs~~recognize the need to further educate and train ophthalmic surgeons about our ICLs and our ICL procedure. We also plan to leverage the EVO Experience Center at our headquarters in Lake Forest, ~~bonus~~California, to conduct additional hands-on training and ~~stock~~education in lens-based ~~compensation~~vision ~~expenses~~correction. In addition, we are continuing to invest in enhanced systems and ~~Japan~~tools ~~one-time~~to ~~employee~~make ~~benefits~~ordering and fulfillment faster and easier. In 2026, we will also continue to drive awareness of the ICL procedure to reach even more potential patients and effectively communicate the clinical benefits of our ICLs.

37Focused innovation – innovation remains central to the Company’s future. We are focused on accelerating our innovation pipeline with rigor, prioritizing programs that deliver meaningful clinical and commercial impact. We are driving innovation through focused development, execution with key milestones, and innovative thinking around market needs. Our innovation pipeline footprint will be expanded in 2026 with the full launch of EVO+ in China to allow more patients to have access to this premium, larger optic lens. We also intend to expand our product offering with the launch of additional lens sizes to allow for greater surgeon flexibility.

~~Selling and Marketing Expense~~ 39

~~The~~Results ~~following~~of ~~table presents our selling and marketing expense for the fiscal years presented (dollars in thousands):~~Operations

										Percentage Change
	2024			2023			2022			2024 vs. 2023			2023 vs. 2022
Selling and marketing expense	$	108,322		$	107,834		$	88,856			0.5	%		21.4	%
Percentage of sales		34.5	%		33.4	%		31.2	%

The following table sets forth the percentage of total sales represented by certain items reflected in the Company’s Consolidated Statement of Operations for the period indicated.

Selling and marketing expenses for 2024 increased 0.5% from 2023, due to increased salary-related payroll tax expenses, trade shows and sales meeting expenses, costs and charges associated with the opening of our new EVO Experience Center, sales commission expenses and travel expenses, offset by decreased advertising and promotional activities.


	Percentage of Net Sales
	2025			2024			2023
Net sales(1)		100.0	%		100.0	%		100.0	%
Cost of sales(1)		23.8	%		23.7	%		21.6	%
Gross profit(1)		76.2	%		76.3	%		78.4	%
General and administrative		35.8	%		28.6	%		22.4	%
Selling and marketing		42.8	%		37.3	%		34.7	%
Research and development		16.7	%		14.4	%		12.5	%
Merger transaction and related costs		7.2	%		0.0	%		0.0	%
Restructuring, impairment and related charges		12.0

Filing Compare · STAAR SURGICAL CO