UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, DC 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of report (Date of earliest event reported): March 18, 2024

STAAR Surgical Company

(Exact Name of Registrant as Specified in Charter)

Registrant’s Telephone Number, Including Area Code: 626-303-7902

Not Applicable

(Former Name or Former Address, if Changed Since Last Report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

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

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1 933 (17 CFR §230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2).

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. ☐

Item 7.01 Regulation FD Disclosure.

Representatives of STAAR Surgical Company (the “Company”) will give presentations to investors commencing on March 18, 2024. A copy of the slide presentation they will share is furnished as Exhibit 99.1 to this Current Report and is incorporated herein by this reference.

Item 8.01 Other Events.

On March 18, 2024, the Company issued a press release reporting that more than three million of the Company's Implantable Collamer® Lenses (“ICLs”) have been sold globally, a copy of which is furnished as Exhibit 99.2 to this Current Report and is incorporated herein by this reference.

The information furnished herewith pursuant to Items 7.01 and 8.01 of this Current Report, including Exhibits 99.1 and 99.2, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section. The information in Items 7.01 and 8.01 of this Current Report, and Exhibits 99.1 and 99.2, shall not be incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Exchange Act, whether made before or after the date of this Current Report, regardless of any general incorporation language in the filing.

Item 9.01 Financial Statements and Exhibits

SIGNATURE

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

NASDAQ: STAA Investor Presentation March 2024 Exhibit 99.1

All statements that are not statements of historical fact are forward-looking statements, including statements about any of the following: any financial projections, anticipated financial results, estimates and outlook (including as to net sales, Adjusted EBITDA, and Adjusted EBITDA per diluted share), plans, strategies, and objectives of management for 2024 and beyond or prospects for achieving such plans, expectations for sales, revenue, margin, expenses or earnings, and any statements of assumptions underlying any of the foregoing, including those relating to financial performance in the upcoming quarter, fiscal year 2024 and beyond. Important factors that could cause actual results to differ materially from those indicated by such forward-looking statements include risks and uncertainties related to global economic conditions, as well as the factors set forth in the Company’s Annual Report on Form 10-K for the year ended December 29, 2023 under the caption “Risk Factors,” which is on file with the Securities and Exchange Commission and available in the “Investor Information” section of the Company’s website, www.staar.com, under the heading “SEC Filings.” We disclaim any intention or obligation to update or revise any financial projections or forward-looking statement due to new information or events. These statements are based on expectations and assumptions as of the date of this presentation and are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those described in the forward-looking statements. The risks and uncertainties include the following: global economic conditions; the impact of COVID-19; the discretion of regulatory agencies to approve or reject existing, new or improved products, or to require additional actions before or after approval, or to take enforcement action; international conflicts, trade disputes and substantial dependence on demand from Asia; and the willingness of surgeons and patients to adopt a new or improved product and procedure. We intend to use our website as a means of disclosing material non-public information and for complying with our disclosure obligations under Regulation FD. Such disclosures will be included on our website in the ‘Investor Relations’ sections. Accordingly, investors should monitor such portions of our website, in addition to following our presentations, SEC filings and public conference calls and webcasts. Forward Looking Statements 02

To supplement the Company’s financial measures prepared in accordance with U.S. generally accepted accounting principles (GAAP), this presentation and the accompanying tables include certain non-GAAP financial measures, including Adjusted EBITDA. Management uses these non-GAAP financial measures in its evaluation of Company operating performance and believes investors will find them useful in evaluating the Company’s operating performance, including cash flow generation, and in analyzing period-to-period financial performance of core business operations and underlying business trends. Non-GAAP financial measures are in addition to, not a substitute for, or superior to, measures of financial performance prepared in accordance with GAAP. EBITDA is a non-GAAP financial measure, which is calculated by adding interest income and expense, net; provision for income taxes; and depreciation and amortization to net income. In calculating Adjusted EBITDA and Adjusted EBITDA per diluted share, the Company further adjusts for stock-based compensation expense. As stock-based compensation is a non-cash expense that can vary significantly based on the timing, size and nature of awards granted, the Company believes that the exclusion of stock-based compensation expense can assist investors in comparisons of Company operating results with other peer companies because (i) the amount of such expense in any specific period may not directly correlate to the underlying performance of our business operations and (ii) such expense can vary significantly between periods as a result of the timing of grants of new stock-based awards, including inducement grants in connection with hiring. Additionally, the Company believes that excluding stock-based compensation from Adjusted EBITDA and Adjusted EBITDA per diluted share assists management and investors in making meaningful comparisons between the Company’s operating performance and the operating performance of other companies that may use different forms of employee compensation or different valuation methodologies for their stock-based compensation. Investors should note that stock-based compensation is a key incentive offered to employees whose efforts contributed to the operating results in the periods presented and are expected to contribute to operating results in future periods. Investors should also note that such expenses will recur in the future. In the appendix to this presentation, the Company has included a reconciliation of Adjusted EBITDA and Adjusted EBITDA per diluted share to net income and net income per diluted share, the most directly comparable GAAP financial measure. The Company has also provided a reconciliation of forward-looking Adjusted EBITDA and Adjusted EBITDA per diluted share to net income and net income per diluted share. This represents forward-looking information, and actual results may vary. Please see the risks and assumptions referred to in the Forward Looking Statements section of this presentation. Non-GAAP Financial Information 03

04 Why Invest? STAAR Surgical is Ushering in the Next Generation of Vision Correction with EVO ICL™

The Global Myopia Epidemic Means Our Market Opportunity Is Significant MYOPIA Today: Every third person in the world STAAR EVO ICL’s near and long-term market opportunity remains exciting and vast, despite any transient noise (previously COVID and now macroeconomic headwinds associated with a normal business cycle). Myopia is a global pandemic with no known cure. 2050: Every other person in the world * Normal Myopia Key Factors with Myopia Environmental Factors Genetic Predisposition *BHVI, adapted from Holden et al. 2016 Ophthalmology. 36% of studies defined high myopia as -6.0D or more. Billions of People 05

STAAR / We Are Building Prowess + Momentum to Realize Our Market Opportunity FISCAL YEAR 2023 OUTLOOK $322.4 M 18% ICL Sales Growth 19% $232.4 M ICL Unit Growth Cash, cash equivalents and investments available for sale at Dec. 29, 2023 78.4% Gross Margin 8.8% Operating Margin Net Sales $21.3 M GAAP Net Income $335 M to $340 M $56.7 M $1.15 Adjusted EBITDA Adjusted EBITDA per diluted share Net Sales Fiscal 2024 Outlook Vision 2026 Outlook ~$36 M ~$0.70 Adjusted EBITDA Adjusted EBITDA per diluted share Net Sales 06 $500 M to $550 M In fiscal 2023, we delivered our sixth straight year of sales growth and profitability. Our cash-generative business model and strong balance sheet allow STAAR the flexibility to make a myriad of investment and capital allocation decisions designed to advance EVO ICL™, our state-of-the-art lens-based vision correction technology, and create shareholder value.

07 STAAR / We Are Using Our Increasing Capabilities and Financial Strength to Outpace the Industry We are establishing EVO ICL™ as The First Choice for Doctors and Patients Seeking Visual Freedom * Global ICL unit growth vs. Market Scope global refractive industry procedure growth. ** ICL outperformance = Global ICL unit growth less refractive industry procedure growth. ICL Units Refractive Industry Procedures ICL Outperformance ** ICL unit growth… +26 points above industry (2023)* +28 points above industry (2022)* ICL Grows through Transient Macro and Business Cycle Headwinds

08 STAAR = 3 Million ICLs and Growing… STAAR expects to sell more ICLs in the next three years (2024-2026) than the first 25 years of ICL sales combined. TOTAL ICLs SOLD… ~ 20 YEARS ~ 3 YEARS < 2 YEARS VISION 2026 1999 - 2Q19 2Q22 1Q24E 4Q26E 1 M 2 M 3 M 6 M

The EVO ICL™ Procedure and Collamer® Material Advantage STAAR / Advantages for Surgeons and Patients 09 200+ Peer-Reviewed ICL Clinical Papers Quick procedure and recovery Additive / Preserves the Cornea 3 Million+ Lenses Sold Does not cause dry eye syndrome 3,4 UV Protection 30+ Year History of Safety and Effectiveness Reversible Lens Implant Sharp, clear vision Day & Night 1,2 99.4% of EVO patients surveyed would choose EVO again5 COLLAMER COLLAGEN + POLYMER 1) Martínez-Plaza E, López-Miguel A, López-de la Rosa A, et al. Effect of the EVO+ Visian Phakic Implantable Collamer Lens on Visual Performance and Quality of Vision and Life, Am J Ophthalmol 2021;226:117-125. 2) Packer M. Evaluation of the EVO/EVO+ Sphere and Toric Visian ICL: Six month results from the United States Food and Drug Administration clinical trial. Clinical Ophthalmology. 2022;16:1541-53. 3) Ganesh S, Brar S, Pawar A. Matched population comparison of visual outcomes and patient satisfaction between 3 modalities for the correction of low to moderate myopic astigmatism. Clin Ophthalmol. 2017;11:1253-1263. 4) Naves J.S, Carracedo G, Cacho-Babillo I, Diadenosine nucleotid measurements as dry-eye score in patients after LASIK and ICL surgery. Presented at American Society of Cataract and Refractive Surgery (ASCRS) 2012. 5) STAAR Survey.

STAAR / Our Sales Outlook Is for a Strong Trajectory of Growth 10 APAC 3-Year Sales CAGR (Fiscal 2024-2026) VISION 2026 Sales Opportunities and Hurdles China ~20% 15% to 20% EMEA AMERICAS U.S. 30% to 50% 10% to 15% 25% to 30% APAC Fiscal 2024 ICL Growth * China approx. 10% GrowthAll Other Countries Flat 7% EMEA AMERICAS U.S. Growth of $2M in 2H24 will result in approx. 10% for FY24 Flat 10% Pace of EVO ICL adoption down the diopter curve, e.g., increasing utilization of EVO ICL -6D to -8D and above for refractive vision correction. Country mix (Direct vs. Hybrid/Distributor)
Success of U.S. market building initiatives
Success of initiatives in other markets globally
Macroeconomic environment * On February 26, 2024, STAAR provided Fiscal 2024 ICL sales growth outlook (Year 1 of 3-Year Plan) and reaffirmed Vision 2026 3-Year Outlook. .

Our Strategic Priorities and Growth Initiatives ... 11

12 Strategic Priorities and Growth Initiatives Increasing Surgeon Confidence in Measurement of the Eye and Lens Size Selection 1 Increasing -6D to -8D Sales Mix 2 New Product Innovation 3 Growing New and Emerging markets 4 Creating a High-Performance Organization 5

PRE-OPERATIVE INTRA-OPERATIVE POST-OPERATIVE Eye measurement and lens size selection Surgery Patient follow-up and understanding outcomes Strengthening Commercial Organization Supporting Research and New Clinical Papers Investing to Accelerate EVO ICL Market Share Capture STAAR Investments Department of Global Professional Education and Training
Independent Investigator Trials (IIT) and Independent Medical Education (IME)
STAAR University Medical Affairs Website
Technical Solutions, e.g.,  exploring intermediate lens sizes and AI-based lens size selection tools Increasing Surgeon Confidence Globally Eye Measurement and Lens Size Selection 13

Low Myopia
(below -3D) Moderate Myopia
(-3 to -6D) High Myopia
(-6 to -10D) Extreme Myopia
(above -10D) SMILE ICL LASIK EVO ICL Movement Down the Diopter Curve* China Case Study – Increasing Surgeon Confidence at Our Largest Customer (2021 vs. 2018-2020) 14 46.6% 46.2% 1 2 93.6% 6.0% 2 52.8% 23.3% 1 46.8% 2021 45.4% 1 2 2021 2021 2021 2 1 56.2% 35.1% 1 2 51.9% 38.8% 1 2 55.9% 21.0% 1 2 49.7% 31.7% 2 2018-2020 2018-2020 2018-2020 1 2018-2020 * The #1 and #2 procedures in each myopia category (extreme, high, moderate, and low) are shown only. The remaining mix may include ICL, SMILE, or LASIK if not shown.

Presbyopia New Product Innovation EVO VIVA™ Sphere and Toric Injectors ACCUJECT™ Ordering System EVO+ Next Gen
EVO STELLA™ Internal R&D CHINA and Partnerships 15

Next Stages of Growth STAAR / We Are Making Investments in New and Emerging Markets UNITED STATES Population 340 Million MEXICO Population 128 Million INDONESIA Population 278 Million BRAZIL Population 216 Million Facts and Data Among the 80 million new MACs [middle-class and affluent consumer], over 70% of this group will be from tier-3 cities and below, making lower-tier cities an increasingly important part of the market… Our research also shows that even during the relatively difficult last few years, Chinese consumers demonstrated a strong desire to trade up and an increased willingness to pay a premium for quality across product categories. - BCG, The Next Chapter in China’s Consumer Story, June 22, 2023 Consider these numbers. The middle class is the fastest-growing major segment of the Indian population in both percentage and absolute terms, rising at 6.3 percent per year between 1995 and 2021. It now represents 31 percent of the population and is expected to be 38 percent by 2031 and 60 percent in 2047. - Economic Times, How the Middle Class will Play the Hero in India’s Rise, July 9, 2023 INDIA Population 1.4 Billion CHINA Population 1.4 Billion 16

17 STAAR / We Are Creating a High-Performance Organization VISION Voice of Customer Corporate Values Exciting Global Growth
The First Choice for Doctors and Patients Seeking Visual Freedom Voice of Employees A Facts and Data-Driven Organization THE ORGANIZATION STRUCTURE & TEAM TO EXECUTE A VITAL FEW STRATEGIC PRIORITIES

18 STAAR / Governance and Leadership STAAR Corporate Officers Arthur Butcher Tom Frinzi Stephen C. Farrell Wei Jiang Aimee S. Weisner K. Peony Yu, MD TOM FRINZI Chair of the Board, President and CEO Elizabeth Yeu, MD WARREN FOUST Chief Operating Officer PATRICK WILLIAMS Chief Financial Officer Lilian Zhou, CFA Board of Directors MAGDA MICHNA, PHD Chief Clinical, Regulatory and Medical Affairs Officer KEITH HOLLIDAY, PHD Chief Technology Officer SCOTT BARNES, MD Chief Medical Officer NATHANIEL SISITSKY General Counsel and Corporate Secretary

IT’S OUR TIME… IT’S EVO’S TIME! 19

Appendix ... 20

STAAR Surgical ICL Sales by Geography 21

Reconciliation of Non-GAAP Financial Measures STAAR Surgical 22 Net Income to Adjusted EBITDA (in 000's except for per share data) Unaudited     Q1-23   Q2-23   Q3-23   Q4-23   2023     2024 Outlook(2)    Net income - (as reported)     $ 2,710     $ 6,064     $ 4,817     $ 7,756     $ 21,347     $ 0   Provision (benefit) for income taxes       2,009       2,428       1,929       5,983       12,349       0   Other (income) expense, net       (1,919 )     105       (451 )     (3,334 )     (5,599 )     2,000   Depreciation       1,113       1,285       1,345       1,368       5,111       4,000   Amortization of Intangible assets       7       10       (2 )     (2 )     13       0   Stock-based compensation       6,065       8,423       8,846       182       23,516       30,000   Adjusted EBITDA     $ 9,985     $ 18,315     $ 16,484     $ 11,953     $ 56,737     $ 36,000   Adjusted EBITDA as a % of Revenue       13.6 %     19.8 %     20.5 %     15.7 %     17.6 %     10.5%                                                       Net income per share, diluted- (as reported)     $ 0.05     $ 0.12     $ 0.10     $ 0.16     $ 0.43     $ 0.00   Provision (benefit) for income taxes       0.04       0.05       0.04       0.12       0.25       0.00   Other (income) expense, net       (0.04 )     -       (0.01 )     (0.07 )     (0.11 )     0.04   Depreciation       0.02       0.03       0.03       0.03       0.10       0.08   Amortization of Intangible assets       -       -       -       -       -       0.00   Stock-based compensation       0.12       0.17       0.18       -       0.48       0.58   Adjusted EBITDA per share, diluted(1)     $ 0.20     $ 0.37     $ 0.33     $ 0.24     $ 1.15     $ 0.70                                                       Weighted average shares outstanding - Diluted       49,500       49,516       49,370       49,242       49,427       52,000   (1) Adjusted EBITDA per diluted share may not add due to rounding (2) 2024 Outlook lines items are all approximations and assumes breakeven Net Income

Current Global Refractive Surgery Market is ~4 Million Procedures Annually Top 15 Refractive Procedure Markets * Company estimates as of January 2024. 23 STAAR’s EVO ICL™ ~15% of the Refractive Procedure Market in Fiscal 2023

STAAR / EVO ICL™ Market Share Estimates as of January 2, 2024 * * Company estimates based on Market Scope, Refractive Surgery Council and survey data as of January 2, 2024, and estimated global refractive procedure volumes in 2023 of approximately 4.1 million. 2023 2018 EVO ICL is a unique technology. Our market share capture in Japan, China and South Korea is representative of our market share opportunity in every market in which we operate. In every market we have initially faced a variety of obstacles to gain share and add procedures to the refractive market, but we have and continue to work successfully to overcome any obstacles, getting better at doing so over time. 24

SALES OPERATING MARGIN 15% 20% Approximately Approximately TO 12% 16% Approximately Approximately TO 3-Year Sales CAGR (2024-2026) GAAP OPERATING MARGIN (2024-2026) ANNUAL GROWTH RANGE Y/Y ANNUAL OPERATING MARGIN $500 TO $550 MILLION Approximately Fiscal 2026 Sales $60 TO $90 MILLION Approximately Fiscal 2026 Operating Income TARGET SALES AND OPERATING MODEL STAAR / Vision 2026 25

Happy EVO ICL Patients and Surgeons Globally! 26

STAAR Surgical Celebrates Three Million Implantable Collamer® Lenses

LAKE FOREST, CA, March 18, 2024--- STAAR Surgical Company (NASDAQ: STAA), a leading developer, manufacturer and marketer of the EVO family of Implantable Collamer® Lenses (EVO ICL™) for myopia, astigmatism and presbyopia, today announced that more than three million ICLs have been sold globally.1

“We extend our sincere gratitude to the surgeons and clinicians with whom we partner and to their patients who have chosen our ICLs for their vision correction as we celebrate our three million lens milestone,” said Tom Frinzi, President and CEO of STAAR Surgical. “EVO ICL is the next logical step in refractive innovation with clear differentiators in patient outcomes and satisfaction. Our lens-based technology is ushering in the next generation of vision correction by helping to free patients from the struggle of daily contacts and eyeglasses.”

EVO ICL is an implantable lens designed to correct a wide range of vision correction needs, including myopia with and without astigmatism, through a minimally invasive procedure. The EVO ICL lens is implanted between the iris (the colored part of the eye) and the natural crystalline lens in a quick and safe 20-30 minute procedure. It’s biocompatible and does not remove corneal tissue, so it works with the natural eye, and the lens implant is removable by a surgeon, if desired. Myopia (nearsightedness) is the most common refractive visual error and is a global epidemic that is expected to impact over half the world’s population by 2050.2

1EVO ICL accounts for approximately 2.5 million of the 3 million total ICLs sold.

2 Ophthalmology 2016;123:1036-1042 © 2016 by the American Academy of Ophthalmology.

About STAAR Surgical

STAAR, which has been dedicated solely to ophthalmic surgery for over 40 years, designs, develops, manufactures and markets implantable lenses for the eye. These lenses are intended to provide visual freedom for patients, lessening or eliminating the reliance on glasses or contact lenses. All of these lenses are foldable, which permits the surgeon to insert them through a small incision. STAAR’s lens used in refractive surgery is called an Implantable Collamer® Lens or “ICL,” which includes the EVO ICL™ product line. More than 3,000,000 ICLs have been sold to date and STAAR markets these lenses in over 75 countries. To learn more about the ICL go to: EVOICL.com. Headquartered in Lake Forest, CA, the company operates manufacturing and packaging facilities in Aliso Viejo, CA, Monrovia, CA, and Nidau, Switzerland. For more information, please visit the Company’s website at www.staar.com.

Important Safety Information for EVO ICL

The EVO Visian ICL lens is intended to correct/reduce nearsightedness between -3.0 D up to -20.0 D and treat astigmatism from 1.0 D to 4.0 D. If you have nearsightedness within these ranges, EVO Visian ICL surgery may improve your distance vision without eyeglasses or contact lenses. Because the EVO Visian ICL corrects for distance vision, it does not eliminate the need for reading glasses, you may require them at some point, even if you have never

worn them before. Since implantation of the EVO Visian ICL is a surgical procedure, before considering EVO Visian ICL surgery you should have a complete eye examination and talk with your eye care professional about EVO Visian ICL surgery, especially the potential benefits, risks, and complications. You should discuss the time needed for healing after surgery. Complications, although rare, may include need for additional surgical procedures, inflammation, loss of cells from the back surface of the cornea, increase in eye pressure, and cataracts. You should NOT have EVO Visian ICL surgery if your doctor determines that 1) the shape of your eye is not appropriate, 2) you do not meet the minimum endothelial cell density for your age at the time of implantation, 3) you have moderate to severe glaucoma, 4) your vision is not stable; or 5) if you are pregnant or nursing.

For additional information with potential benefits, risks and complications please visit evoicl.com.

Investors & Media

Brian Moore

Vice President, Investor Relations and Corporate Development

(626) 303-7902, Ext. 3023

bmoore@staar.com

Source: STAAR Surgical Company