Device product
Labeled in part: I Color Complete / Color Lens, blister packing, 14.5mm. (Additional colors include: 1) Illusion style, Chestnut Brown, Violet and others and 2) 2 Tone style: like Misty Blue among others)Eye contact lens Product Usage - Eye contact lens
Z-0950-2015
Product summary
- Event
- Event 69419
- Status
- Terminated
- Classification
- Class II
- Quantity
- 750 units
- Official record key
device-enforcement:Z-0950-2015
Official wording
Reason: A surveillance sample collected by FDA confirmed the presence of Bacillus Cereus and Bacillus Lentus in the contact lenses. I Color Color Complete brand color contact lenses are unapproved medical devices.
Code information: ALL LOTS / CODES
Distribution pattern: Worlldwide Distribution - USA including Texas, California, Florida, and St. Lucia, Barbados and St. Marten.
Derived failure modes
-
Microbial contamination
presence of Bacillus Cereus