Device product
Clariti 1-day toric soft contact lenses, Power -1.00 -1.25/90
Z-1282-2023
Product summary
- Event
- Event 91793
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 3150
- Official record key
device-enforcement:Z-1282-2023
Official wording
Reason: The lenses manufactured in the affected lot were made with a misaligned axis resulting in lenses with the incorrect power.
Code information: Lot Number W0124677
Distribution pattern: Worldwide - US Nationwide distribution in the states of FL, IL, NY, UT, and WI. The country of Canada.
Derived failure modes
-
Unknown
The lenses manufactured in the affected lot were made with a misaligned axis resulting in lenses with the incorrect power.