Is 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
recalled?

Question

Is 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
 recalled?

Accepted Answer

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.

Status: Voluntary: Firm initiated

Initial Firm Notification: Telephone

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

Intertrade Imports Inc.: 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.

Affected Products

Additional Information

Were You Affected by This Recall?

Intertrade Imports Inc.: 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.

Affected Products

Additional Information

Were You Affected by This Recall?