Z-2982-2018 Class III Terminated
Recall Details
- Product Type
- Devices
- Report Date
- September 12, 2018
- Initiation Date
- July 3, 2018
- Termination Date
- February 28, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4 vials
Product Description
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.
Reason for Recall
Vials labeled for the prescriptions contained incorrect lenses
Distribution Pattern
US Distribution in the states of: CA, GA, IL, MD, NC, NJ, NV, OH, OK, PA, TN, TX and UT.
Code Information
B3225920 UDI-(01)00785811435660/(10)18101PTC008 B3237210 UDI-(01)00785811435660/(10)18101PTC008 B3237220 UDI-(01)00785811435660/(10)18101PTC008 B3237910 UDI-(01)00785811435660/(10)18101PTC008