Staar Surgical Recalls Intraocular Lenses Due to Glass Particles
Staar Surgical is recalling specific Afinity and nanoFLEX intraocular lenses because glass particles may be present in the storage vials.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a potential for physical injury (glass particles) but no reported illnesses or injuries are stated in the source text, fitting the 'High' criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Staar Surgical Company is recalling a limited number of nanoFLEX CC4204A and Afinity CQ2015A intraocular lenses. The recall is being conducted due to the potential presence of glass particles in the storage vials.
The affected products are intended for the visual correction of aphakia in persons 60 years of age or older in whom a cataractous lens has been removed by cataract extraction. The recall involves 3,361 units distributed nationwide across 33 states, including Alabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Kentucky, Iowa, Illinois, Indiana, Louisiana, Massachusetts, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Wisconsin, and West Virginia.
Healthcare providers and patients should check their inventory and patient records for the specific serial numbers listed in the official recall notice. If a patient has received one of these lenses, they should contact their eye care provider for guidance on next steps.
The recalled product
- Product
- Afinity CQ2015A Intraocular Lens The visual correction of aphakia in persons 60 years of age or older in whom a cataractous lens has been removed by cataract extraction.
- Manufacturer
- Staar Surgical Co.
- Affected units
- 3,361
Distribution
Part of a larger recall action
This product is one of 2 recalled by Staar Surgical Co. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same manufacturer · Staar Surgical Co.
See all →- HighStaar Surgical Recalls STAAR AQ Cartridge-FP Intraocular Lens Delivery Systems
FDA (Devices) · 2016-06-22
- HighStaar Surgical Recalls Intraocular Lenses Due to Glass Particles
FDA (Devices) · 2013-07-24
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