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
FDA Recall Z-0951-2015 · Posted 2015-01-12
Recalling FirmIntertrade Imports Inc.
Recall StatusTerminated
Product CodeLPM
Date Initiated2014-09-10
Date Terminated2019-10-07
Product Quantity2850 each
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.
Firm Action
The firm verbally contacted each distributor on September 10, 2014 to notify them about the recall and actions that needs to be taken.
Root Cause
Material/Component Contamination
Distribution Pattern
Worlldwide Distribution - USA including Texas, California, Florida, and St. Lucia, Barbados and St. Marten.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.