Alden Optical recalls Zenlens Toric-Gas Permeable Contact lenses for Daily Wear in a 10-cc polycarbonate vial (Rx) as follows: Zenlens FT(Fro…

Recall date

July 3, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2981-2018

FDA classification

Class III

Brand / firm

Alden Optical

Sold / distributed

US Distribution in the states of: CA, GA, IL, MD, NC, NJ, NV, OH, OK, PA, TN, TX and UT.

Why it was recalled

Vials labeled for the prescriptions contained incorrect lenses

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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.