Device product
ACUVUE VITA soft (hydrophilic) contact lens (spherical) for daily wear. Base Curve 8.8, Refractive Power -1.50
Z-1865-2021
Product summary
- Event
- Event 87947
- Status
- Terminated
- Classification
- Class II
- Quantity
- 6,780 lenses
- Official record key
device-enforcement:Z-1865-2021
Official wording
Reason: Potential that a limited number of individual contact lens packages have an incomplete packaging seal.
Code information: UPC 733905989612 LOT # BOOWWWL
Distribution pattern: Worldwide Distribution. US nationwide, Canada, Germany, Austria, Belgium, France, Luxemburg, Netherland, Portugal, Spain, Sweden, Switzerland, and Trinidad and Tobago.
Derived failure modes
-
Labeling or packaging
incomplete packaging