Recall Z-0950-2015 ยท LPM Lenses, Soft Contact, Extended Wear
Intertrade Imports Inc.
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
| Date | Jan 12, 2015 (initiated Sep 10, 2014) |
| Status | Terminated |
| 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. |
| Root cause | Material/Component Contamination |
| Action | The firm verbally contacted each distributor on September 10, 2014 to notify them about the recall and actions that needs to be taken. |
| Quantity | 750 units |
| Distribution | Worlldwide Distribution - USA including Texas, California, Florida, and St. Lucia, Barbados and St. Marten. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.