Medical device recalls Moderate risk

Intertrade Imports Inc. recalls Labeled in part: I Color Complete / Color Lens, blister packing, 14.5mm. (Additional colors include: 1) Illusion style,…

Recall date
September 10, 2014
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0950-2015
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. 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 / 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

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