Staar Surgical (STAA) risk factors, FY2025 10-K

Staar Surgical's FY2025 10-K, filed Mar 03, 2026, lists 44 risk factors in 4 groups. Against the prior year's 46: 2 new, 4 dropped, 17 substantially reworded.

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Risk factors listed
444 groups
New this year
2vs 46 last year
Dropped
4since the prior 10-K
Substantially reworded
17of those kept
Section length
12k wordsItem 1A

What the changes say

  • The risk profile is dominated by dependence on ICL lens sales, international economic exposure, and recent executive turnover.

What changed since the prior 10-K

New

  • NewRisks Related to Our Business

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

    Negative publicity regarding complications from LASIK or other refractive surgeries could decrease patient interest and reduce ICL sales growth.

  • NewRisks Related to Our Business

    the end of December 27, 2024. If China experiences a significant or prolonged slowdown or disruption to its economy, or social or political unrest, we may experience a significant reduction in sales in the future

    Economic slowdowns, social unrest, and trade tensions or tariffs involving China and the U.S. could reduce our future sales.

Dropped

  • DroppedRisks Related to Our Business

    regulatory approvals to use alternative suppliers may be a lengthy and uncertain process during which production could be delayed and we could lose sales

  • DroppedRisks Related to Regulatory and Compliance

    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

  • DroppedRisks Related to Regulatory and Compliance

    to recall the modified product until we obtain clearance or approval, and we may be subject to significant regulatory fines or penalties

  • DroppedRisks Related to Ownership of Our Common Stock

    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

Reworded

  • 79% rewrittenRisks Related to Our Business

    Disruptions in our supply chain or failure to adequately forecast product demand could result in significant delays or lost sales

    Added specific consequences of supply chain disruptions, noting that qualifying alternative suppliers is a lengthy process that could delay production and lose sales.

  • 73% rewrittenRisks Related to Ownership of Our Common Stock

    Because we do not intend to pay dividends, stockholders will benefit from an investment in our common stock only if it appreciates in value

    Added a clear statement that investors will benefit only from common stock appreciation and that there is no guarantee of price maintenance.

  • 68% rewrittenRisks Related to Ownership of Our Common Stock

    Ownership of our common stock is concentrated among a few investors, which may affect the ability of a third party to acquire control of us. Substantial sales by such investors could cause our common stock price to decline

    Updated ownership figures, noting Broadwood owns 31%, top five own 66%, and details of the January 2026 Cooperation Agreement and board changes following the terminated Alcon merger.

  • 63% rewrittenRisks Related to Regulatory and Compliance

    If we recall a product, the cost and damage to our reputation could harm our business

    Added the risk that inconvenience from recalls and supply interruptions could cause medical professionals to stop using products.

  • 59% rewrittenRisks Related to Our Business

    If we are not able to manage growth successfully, it could adversely affect our business, financial condition, and results of operations

    Updated fiscal year references, noting net sales decreased in fiscal 2025 compared to fiscal 2024.

  • 59% rewrittenRisks Related to Our Business

    Unfavorable economic conditions or negative publicity concerning complications of laser eye surgery, or medical devices in general, could hurt sales of our refractive products

    Updated revenue reference to January 2, 2026, and expanded economic stagnation risks to include global markets.

  • 57% rewrittenRisks Related to Our Business

    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

    Updated foreign sales percentage from 94% in 2024 to 91% in 2025.

  • 44% rewrittenRisks Related to Our Business

    The loss of key employees, or our inability to recruit, hire and retain skilled and experienced personnel, could negatively impact our ability to effectively manage and expand our business

    Added details regarding 2025 and 2026 leadership changes, including CEO and CFO appointments, interim Co-CEOs, and the search for a permanent CEO.

  • 44% rewrittenRisks Related to Our Business

    We reported a decrease in revenue and a net loss in fiscal 2025 and 2024, and we may not be able to return to our growth and profitability trajectory

    Was: We reported a decrease in revenue and a net loss in fiscal 2024, and we may not be able to return to our growth and profitability trajectory

  • 40% rewrittenRisks Related to Regulatory and Compliance

    If we modify our products, we may have to obtain new marketing clearances or approvals or may have to cease marketing or recall the modified products until clearances or approvals are obtained

  • 39% rewrittenRisks Related to the Ophthalmic Products Industry

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

  • 38% rewrittenRisks Related to Our Business

    We are vulnerable to any loss of use of our principal manufacturing facility

  • 35% rewrittenRisks Related to Our Business

    A slowdown or disruption to the Chinese economy or worsening trade relations between the U.S. and China could materially impact our business and results of operations

  • 26% rewrittenRisks Related to the Ophthalmic Products Industry

    Unless we keep pace with advances in our industry and persuade physicians to adopt our new products, our sales will not grow and may decline

  • 24% rewrittenRisks Related to Our Business

    Changes in tax laws could result in additional tax liabilities

  • 21% rewrittenRisks Related to Our Business

    Our defined benefit pension plans are currently underfunded and we may be subject to significant increases in pension benefit obligations under those pension plans

  • 21% rewrittenRisks Related to Ownership of Our Common Stock

    The market price of our common stock has been and will likely continue to be volatile

All 44 risk factors

Headings as the filing states them, in filing order.

Risks Related to Our Business

  1. 01We reported a decrease in revenue and a net loss in fiscal 2025 and 2024, and we may not be able to return to our growth and profitability trajectory44% rewritten
  2. 02Our reliance on independent distributors in international markets exposes us to commercial and other risks
  3. 03A slowdown or disruption to the Chinese economy or worsening trade relations between the U.S. and China could materially impact our business and results of operations35% rewritten
  4. 04Unfavorable economic conditions or negative publicity concerning complications of laser eye surgery, or medical devices in general, could hurt sales of our refractive products59% rewritten
  5. 05a global basis could slow ICL sales growth or, if severe, cause declines in sales, which could materially harm our businessNew
  6. 06Disruptions in our supply chain or failure to adequately forecast product demand could result in significant delays or lost sales79% rewritten
  7. 07Because 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 tariffs57% rewritten
  8. 08the end of December 27, 2024. If China experiences a significant or prolonged slowdown or disruption to its economy, or social or political unrest, we may experience a significant reduction in sales in the futureNew
  9. 09Changes in our effective tax rate or additional tax liabilities could adversely impact our net income
  10. 10Changes in tax laws could result in additional tax liabilities24% rewritten
  11. 11We are vulnerable to any loss of use of our principal manufacturing facility38% rewritten
  12. 12Public health crises, political crises, and other catastrophic events or other events outside of our control may impact our business
  13. 13The loss of key employees, or our inability to recruit, hire and retain skilled and experienced personnel, could negatively impact our ability to effectively manage and expand our business44% rewritten
  14. 14We compete with much larger companies and low-cost Asian manufacturers
  15. 15We could experience losses due to product liability claims
  16. 16Our defined benefit pension plans are currently underfunded and we may be subject to significant increases in pension benefit obligations under those pension plans21% rewritten
  17. 17Our activities involve hazardous materials, emissions, and use of an irradiator and may subject us to environmental liability
  18. 18Data corruption, cyber-based attacks or network security breaches and/or noncompliance with data protection and privacy regulations could negatively impact our operations
  19. 19The increased use of social media platforms and mobile technologies presents additional risks and challenges
  20. 20Acquisitions of technologies, products, and businesses could disrupt our operations, involve increased expenses and present risks not contemplated at the time of the transactions
  21. 21If we are not able to manage growth successfully, it could adversely affect our business, financial condition, and results of operations59% rewritten
  22. 22Corporate responsibility, specifically related to environmental, social and governance (ESG) matters, may impose additional costs, expose us to reputational and emerging areas of risks, and could negatively affect our business
  23. 23Climate changes and extreme weather conditions could negatively affect our business

Risks Related to the Ophthalmic Products Industry

  1. 24Unless we keep pace with advances in our industry and persuade physicians to adopt our new products, our sales will not grow and may decline26% rewritten
  2. 25Resources devoted to research and development may not yield new ophthalmic products that achieve regulatory approval or commercial success39% rewritten
  3. 26We may be required to conduct extensive clinical trials to demonstrate safety and effectiveness of new or enhanced ophthalmic products, such clinical trials are expensive, complex, can take years to complete, and have highly uncertain outcomes
  4. 27Complying with government regulation substantially increases the cost of developing, manufacturing and selling our ophthalmic products
  5. 28We depend on proprietary technology, but our intellectual property protections may be limited
  6. 29We may not successfully replace our existing products, including those that lose or have lost patent protection
  7. 30While 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

Risks Related to Regulatory and Compliance

  1. 31We are subject to extensive government regulation worldwide, which increases our costs and could prevent us from selling our products
  2. 32Regulatory issues may adversely impact our operations
  3. 33Laws pertaining to healthcare fraud and abuse could materially adversely affect our business, financial condition, and results of operations
  4. 34If we recall a product, the cost and damage to our reputation could harm our business63% rewritten
  5. 35Changes in U.S. FDA or international regulations related to product approval, including those that apply retroactively, could make us less competitive and harm our business
  6. 36If 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
  7. 37If we modify our products, we may have to obtain new marketing clearances or approvals or may have to cease marketing or recall the modified products until clearances or approvals are obtained40% rewritten
  8. 38Non-compliance with anti-corruption laws could lead to penalties or harm our reputation
  9. 39Investigations and allegations, whether or not they lead to enforcement action or litigation, can materially harm our business and our reputation

Risks Related to Ownership of Our Common Stock

  1. 40The market price of our common stock has been and will likely continue to be volatile21% rewritten
  2. 41Because we do not intend to pay dividends, stockholders will benefit from an investment in our common stock only if it appreciates in value73% rewritten
  3. 42stockholders must give advance notice to nominate directors or propose other business
  4. 43Ownership of our common stock is concentrated among a few investors, which may affect the ability of a third party to acquire control of us. Substantial sales by such investors could cause our common stock price to decline68% rewritten
  5. 44Future sales of our common stock could reduce our stock price

Other Staar Surgical 10-Ks

  • FY2024 10-K risk factors
    46 risks

    Staar Surgical relies almost entirely on ICL lens sales, with China accounting for 51 percent of fiscal 2024 revenue. Manufacturing is concentrated at a single facility in Monrovia, California, exposing operations to localized disruptions. Independent international distributors handle the majority of non-U.S. sales.

    Filed Feb 21, 2025

About this page

The headings are the filing's own. The one-line readings and the overview are automated and can be wrong: read Item 1A of the 10-K for the exact wording.