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Staar Surgical Co. recalls nanoFLEX CC4204A Intraocular Lens Correct aphakia in persons 60 years of age or older in whom a cataractous lens has
Recalled July 24, 2013 · FDA recall Z-1746-2013 · Staar Surgical
Hazard
STAAR Surgical Company is recalling a limited number of nanoFLEX CC4204A and Afinity CQ2015A intraocular lenses due to the potential presence of glass particles in the storage vial. · FDA Class II
Units
3,361 units total
Sold at
Nationwide distribution: USA including 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.
Description
STAAR Surgical Company is recalling a limited number of nanoFLEX CC4204A and Afinity CQ2015A intraocular lenses due to the potential presence of glass particles in the storage vial.
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(s)
Staar Surgical Co.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →