medical Class III Updated 2018-09-12

Alden Optical recalls Zen RC Toric-Gas permeable contact lenses for Daily Wear in

Recalled Product

Zen RC Toric-Gas permeable contact lenses for Daily Wear in a 10-cc polycarbonate vial (Rx)as follows: Zen RC TPC (Toric Peripheral Curve) Zen RC FT (Front Toric Optics) 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.


Hazard / Issue

Vials labeled for the prescriptions contained incorrect lenses

Issued by

FDA

Affected States: CA, GA, IL, MD, NC, NJ, NV, OH, OK, PA, TN, TX, UT
Lot/Code Info: B3225920 UDI-(01)00785811435660/(10)18101PTC008 B3237210 UDI-(01)00785811435660/(10)18101PTC008 B3237220 UDI-(01)00785811435660/(10)18101PTC008 B3237910 UDI-(01)00785811435660/(10)18101PTC008
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