BEUDAMED
    FDA Recall Terminated

    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

    Recall: Z-0951-2015 · Initiated September 10, 2014

    Recall

    Recall Number
    Z-0951-2015
    Event Number
    69419
    Firm
    Intertrade Imports Inc.
    FEI Number
    3007310352
    Product Code
    LPM
    Status
    Terminated
    Root Cause
    Material/Component Contamination
    Initiated
    September 10, 2014
    Posted
    January 12, 2015
    Terminated
    October 7, 2019
    Address
    4227 Clinton Ave, Jacksonville, FL, 32207-6852

    Description

    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

    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.

    Action

    The firm verbally contacted each distributor on September 10, 2014 to notify them about the recall and actions that needs to be taken.

    Distribution

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

    Quantity

    2850 each