BEUDAMED
    FDA Enforcement Class II 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 · Reported January 21, 2015

    Enforcement

    Recall Number
    Z-0951-2015
    Event ID
    69419
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Intertrade Imports Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    January 21, 2015
    Initiation Date
    September 10, 2014
    Classification Date
    January 12, 2015
    Termination Date
    October 7, 2019
    Address
    4227 Clinton Ave, Jacksonville, FL, 32207-6852, United States

    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.

    Code Info

    ALL LOTS / CODES

    Distribution

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

    Quantity

    2850 each