BEUDAMED
    FDA Enforcement Class II Ongoing

    Color contact lenses labeled under the following brands: Diamond, Fierce, Ambition, Circle Collection, Lunatic, Fright, Desire and See Clear.

    Recall: Z-1404-2017 · Reported March 15, 2017

    Enforcement

    Recall Number
    Z-1404-2017
    Event ID
    76279
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    The See Clear Company
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 15, 2017
    Initiation Date
    January 6, 2017
    Classification Date
    March 3, 2017
    Address
    4995 Buford Hwy Ste 102, N/A, Peachtree Corners, GA, 30071-2721, United States

    Description

    Color contact lenses labeled under the following brands: Diamond, Fierce, Ambition, Circle Collection, Lunatic, Fright, Desire and See Clear.

    Reason

    Sterility and Misbranding: Lenses may not be sterile and may be labeled with erroneous lot numbers and expiry dates.

    Code Info

    All lots of lenses sold between 10/31/2013 to 10/31/2016

    Distribution

    Worldwide Distribution: US (nationwide) including states of: AZ, CA, DE, FL, GA, HI, LA, NJ, NY, NV, ON, PA and WA; and country of: Canada.

    Quantity

    119,829 units