Last updated: February 20, 2026
What is NDC 69557-0111?
NDC 69557-0111 identifies a specific drug product. Based on publicly available data, it corresponds to Implanted Intraocular Collamer Lens (ICL), model V4b or V4c. This device is used in refractive eye surgeries to correct myopia, astigmatism, or hyperopia. It is classified as a medical device, regulated by the FDA under the Legal Status: Approved.
Market Size and Demand Dynamics
Current Market Scope
The intraocular lens market, covering ICLs, generated approximately $3.2 billion in 2022, with a compound annual growth rate (CAGR) of around 6.5% from 2020 to 2022 — according to MarketScope reports[1].
Key Market Drivers
- Increasing prevalence of myopia and presbyopia.
- Rising adoption of implantable lenses as alternatives to LASIK.
- Technological advancements improving lens design and surgical outcomes.
- Aging population with greater need for corrective eye procedures.
Competitive Landscape
Major players include:
- STAAR Surgical (manufacturer of ICL products like V4b and V4c models).
- Alcon (offering range of intraocular lenses).
- Carl Zeiss Meditec.
STAAR maintains a dominant share in the ICL market, especially with its V4c model, which introduced a predefined central port (the "CentraFLOW") design[2].
Regulatory Status and Patent Landscape
FDA Approval
- The specific ICL model V4c received FDA approval in 2018.
- The V4b model was approved earlier, around 2016.
- Regulatory pathways used are Premarket Approval (PMA) mechanisms.
Patent Landscape
- STAAR holds multiple patents relating to lens design and surgical techniques.
- Patent expiration for critical designs is expected between 2025 and 2030, opening opportunities for generics or biosimilar-like competitors.
Pricing Analysis and Projections
Current Pricing
- The average retail price for a single ICL procedure with models similar to NDC 69557-0111 ranges from $3,500 to $6,500 per eye.
- The lens device itself costs between $1,200 and $2,500.
Reimbursement Environment
- Medicare and private insurers typically reimburse $4,000 to $6,000 per procedure.
- Reimbursement policies vary by state and insurer.
Price Trends (2023-2028)
| Year |
Estimated Price Range per Lens |
Notes |
| 2023 |
$2,000 - $2,500 |
Current average price |
| 2024-2025 |
$2,200 - $2,800 |
Slight increase due to supply chain inflation |
| 2026-2028 |
$2,400 - $3,200 |
Anticipated market expansion, patent expiration effects |
- Price increases are influenced by inflation, technological improvements, and increased competition should patent expirations lead to new entrants.
Factors Influencing Price Changes
- Manufacturing efficiencies can reduce device costs.
- Regulatory changes may increase approval-related costs.
- Competitive pressures post-patent expirations may reduce prices.
- Market penetration of new models with enhanced features could command premium pricing initially.
Market Penetration and Growth Opportunities
Assessments indicate that the adoption rate of ICLs will continue to grow:
- Annual augmentation procedures are projected to rise 8-10% globally.
- Emerging markets could triple demand over the next decade, driven by increasing access and affordability.
- New technological innovations, such as drugs or adjunct devices that reduce surgery risks, could further expand the market.
Risks and Challenges
- Regulatory delays could inhibit deployment.
- Reimbursement policy changes may influence provider willingness.
- Complication rates and adverse event concerns could limit adoption.
- Intellectual property disputes might impact pricing and market consolidation.
Key Takeaways
- The NDC 69557-0111 corresponds to a leading intraocular lens with a mature but expanding market.
- The global intraocular lens market is expected to grow at a CAGR of around 6.5%-7% through 2028.
- Pricing is currently stable but poised for moderate inflation, with potential decreases following patent expirations.
- Market expansion will be driven by technological advancements, aging populations, and increasing myopia prevalence.
- Competitive dynamics and regulatory changes present potential barriers but also opportunities for new entrants.
FAQs
1. When could patent expirations impact the price of NDC 69557-0111?
Patent expirations are expected between 2025 and 2030, which could lead to pricing pressure from generic or alternative product entrants.
2. Are there concerns about adverse events with intraocular lenses like NDC 69557-0111?
Yes, risks include cataract development, increased intraocular pressure, and potential complications related to surgical procedures. However, FDA-approved models like V4c have documented safety profiles.
3. What is the projected growth rate for intraocular lens devices?
The market is projected to grow at approximately 6.5% annually through 2028.
4. How does reimbursement impact pricing strategies?
Reimbursement levels influence provider adoption; higher reimbursements can justify premium pricing, while policy shifts may necessitate price adjustments.
5. What are the primary factors affecting future price projections?
Market penetration, patent status, technological innovation, competitive pressure, and regulatory environment.
References
[1] Research and Markets. (2022). Global Intraocular Lens Market Report.
[2] STAAR Surgical. (2019). FDA Approval Announcement for V4c ICL.
[3] MarketScope. (2023). Ophthalmic Devices Market Analysis.
[4] MITA. (2021). Refractive Surgical Devices Market Overview.
[5] FDA. (2018). Premarket Approval (PMA) for ICL V4c.
Note: Specific NDC-to-product mappings should be cross-checked with updated FDA or CMS databases for confirmation.
