Device product
ACUVUE OASYS for ASTIGMATISM brand contact lenses, Base Curve 8.6 Refractive Power -1.00D, -1.25D x 100, 6 pack.
Z-1131-2019
Product summary
- Event
- Event 82402
- Status
- Terminated
- Classification
- Class II
- Quantity
- 300 lenses
- Official record key
device-enforcement:Z-1131-2019
Official wording
Reason: One lot of ACUVUE OASYS¿ for ASTIGMATISM Brand Contact lenses has the potential for a limited number of individual contact lens packages to have an incomplete packaging seal.
Code information: Lot Number on box and individual contact lens package: B00RWF0. UPC: 733905669460
Distribution pattern: Distributed to California.
Derived failure modes
-
Labeling or packaging
incomplete packaging