Device product
Labeled in part: I Color Complete / Crazy Lens, blister packing, 14.5mm, (Additional colors include: #003 White out, #005 Yellow out, #020 Red out, #014 Black out, #070 Manson, #136 Lava, #009 Yellow cat, #073 Red cat, #050 White cat, #032 Soccer ball, #077 Spiral, #071 Target, #057 Wild fire, #056 Spider web, #174 Black moon, #179 Green moon, #180 Zombie, #181 Green hole, and #184 Black hole among others styles) Product Usage - Eye contact lens
Z-0951-2015
Product summary
- Event
- Event 69419
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2850 each
- Official record key
device-enforcement:Z-0951-2015
Official wording
Reason: A surveillance sample collected by FDA confirmed the presence of Bacillus Cereus and Bacillus Lentus in the contact lenses, product is not sterile. 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