Device product
ACUVUE OASYS for ASTIGMATISM Brand Contact Lenses. Lot no. B00NKM0G. Base Curve 8.6, Refractive Power -3.00D-1.25/90.
Z-1744-2020
Product summary
- Event
- Event 85261
- Status
- Terminated
- Classification
- Class II
- Quantity
- 150 lenses.
- Official record key
device-enforcement:Z-1744-2020
Official wording
Reason: Package integrity failure observed during routine shift package integrity testing at an external re-packager.
Code information: Lot no. B00NKM0G. Base Curve 8.6, Refractive Power -3.00D-1.25/90.
Distribution pattern: Nationwide US.
Derived failure modes
-
Labeling or packaging
Package integrity failure