Z-0950-2015 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
- 750 units
Product Description
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
Reason for Recall
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.
Distribution Pattern
Worlldwide Distribution - USA including Texas, California, Florida, and St. Lucia, Barbados and St. Marten.
Code Information
ALL LOTS / CODES