Recall Z-0951-2015 ยท LPM Lenses, Soft Contact, Extended Wear
Intertrade Imports Inc.
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 am
| 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, product is not sterile. 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 | 2850 each |
| 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.