Labeled in part: I Color Complete / Crazy Lens recalled over fire hazard

Recall date

September 10, 2014

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Intertrade Imports Inc. recalls Labeled in part: I Color Complete / Crazy Lens, blister packing, 14.5mm, (Additional colors include: #003 White out, #0…

Recall number

Z-0951-2015

FDA classification

Class II

Brand / firm

Intertrade Imports Inc.

Sold / distributed

Worlldwide Distribution - USA including Texas, California, Florida, and St. Lucia, Barbados and St. Marten.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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