Z-0951-2015 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- January 21, 2015
- Initiation Date
- September 10, 2014
- Termination Date
- October 7, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2850 each
Product Description
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
Reason for Recall
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.
Distribution Pattern
Worlldwide Distribution - USA including Texas, California, Florida, and St. Lucia, Barbados and St. Marten.
Code Information
ALL LOTS / CODES