Device 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.
Z-2982-2018
Product summary
- Firm
- Alden Optical
- Event
- Event 80800
- Status
- Terminated
- Classification
- Class III
- Quantity
- 4 vials
- Official record key
device-enforcement:Z-2982-2018
Official wording
Reason: Vials labeled for the prescriptions contained incorrect lenses
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
Distribution pattern: US Distribution in the states of: CA, GA, IL, MD, NC, NJ, NV, OH, OK, PA, TN, TX and UT.
Derived failure modes
-
Unknown
Vials labeled for the prescriptions contained incorrect lenses