BEUDAMED
    FDA Recall Open, Classified

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

    Recall: Z-1404-2017 · Initiated January 6, 2017

    Recall

    Recall Number
    Z-1404-2017
    Event Number
    76279
    Firm
    The See Clear Company
    FEI Number
    3009384112
    Product Code
    LPL
    Status
    Open, Classified
    Root Cause
    Device Design
    Initiated
    January 6, 2017
    Address
    4995 Buford Hwy, Ste 102, Peachtree Corners, GA, 30071-2721

    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.

    Action

    The firm, The See Clear Company, sent an "URGENT: DEVICE RECALL" letter dated 12/30/2016 to its Consignees on 01/06/2017. The letter described the product, problem and actions to be taken. The consignees were instructed to immediately examine your stock to determine if you have any of the listed product; immediately discontinue distributing the product and promptly return them via parcel post to Norcross facility, ATTENTION: RETURN GOODS; if you have further distributed any of the listed product, immediately contact your accounts, advise them of the recall, and have them return their outstanding recalled stocks to you; and immediately complete and return RECALL RETURN RESPONSE FORM via mail. If you have any questions, contact us at (678) 313-1399.

    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