Staar Surgical Recalls Intraocular Lenses Due to Glass Particles
Staar Surgical is recalling nanoFLEX and Afinity 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 is classified as FDA Class II, and the hazard involves potential glass particles in a medical device, which poses a risk of harm even though specific injury reports are not detailed in the provided text.
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 intraocular lenses intended to correct aphakia in persons 60 years of age or older in whom a cataractous lens has been removed by cataract extraction. The lenses are to be implanted in the posterior chamber and in the capsular bag through a tear-free capsulorhexis.
The recall involves 3,361 units total. Distribution was nationwide across the United States, including the states of AL, AZ, CA, CO, CT, FL, GA, HI, KY, IA, IL, IN, LA, MA, MI, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, PA, SC, TN, TX, UT, VA, WI, and WV. Specific serial numbers for the affected units are listed in the official recall documentation.
The recalled product
- Product
- nanoFLEX CC4204A Intraocular Lens Correct aphakia in persons 60 years of age or older in whom a cataractous lens has been removed by cataract extraction. The IOL is to be implanted in the posterior chamber and in the capsular bag through a tearfree capsulorhexis.
- 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
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