Home / Recalls / Medical Devices
Alden Optical recalls Zenlens Toric-Gas Permeable Contact lenses for Daily Wear in a 10-cc polycarbonate vial (Rx) as follows: Zenlens FT(Fro
Recalled September 12, 2018 · FDA recall Z-2981-2018 · Alden Optical
Hazard
Vials labeled for the prescriptions contained incorrect lenses · FDA Class III
Units
36 vials
Sold at
US Distribution in the states of: CA, GA, IL, MD, NC, NJ, NV, OH, OK, PA, TN, TX and UT.
Description
Vials labeled for the prescriptions contained incorrect lenses
Product
Zenlens Toric-Gas Permeable Contact lenses for Daily Wear in a 10-cc polycarbonate vial (Rx) as follows: Zenlens FT(Front Toric); Zenlens Toric-Zenlens FT + MV (Front Toric+Microvault); Zenlens TPC-(Toric Peripheral Curve); Zenlens TPC + FT- (Toric Peripheral Curve + FrontToric) Zenlens TPC + MV- (Toric Peripheral Curve+Microvault). Catalog Number: AOZNT Zenlens Toric - Zenlens contact lenses are indicated for daily wear for the correction of refractive arnetropia (myopia, hyperopia, and astigmatism) in aphakic and nonaphakic persons with non-diseased eyes.
Manufacturer(s)
Alden Optical
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →