Device product
Color contact lenses labeled under the following brands: Diamond, Fierce, Ambition, Circle Collection, Lunatic, Fright, Desire and See Clear.
Z-1404-2017
Product summary
- Event
- Event 76279
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 119,829 units
- Official record key
device-enforcement:Z-1404-2017
Official wording
Reason: Sterility and Misbranding: Lenses may not be sterile and may be labeled with erroneous lot numbers and expiry dates.
Code information: All lots of lenses sold between 10/31/2013 to 10/31/2016
Distribution pattern: Worldwide Distribution: US (nationwide) including states of: AZ, CA, DE, FL, GA, HI, LA, NJ, NY, NV, ON, PA and WA; and country of: Canada.
Derived failure modes
-
Labeling or packaging
Misbranding