Device product
Alcon PRECISION1 One-Day Contact Lenses, -2.25D.
Z-0326-2026
Product summary
- Event
- Event 97739
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 82 units
- Official record key
device-enforcement:Z-0326-2026
Official wording
Reason: Potential for a weak seal in some units resulting in compromise in sterility.
Code information: GTIN: 00730822254946; Lot Number: A8041128
Distribution pattern: Worldwide - US distribution in the states of Alabama, Arizona, Arkansas, Connecticut, Florida, Idaho, Iowa, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, New Jersey, New York, Oklahoma, Oregon, Tennessee, Texas, Washington and the country of Canada.
Derived failure modes
-
Labeling or packaging
weak seal
-
Sterility assurance
seal in some units resulting in compromise in sterility