BEUDAMED
    FDA Recall Terminated

    Soft Cosmetic Contact Lenses sold under the brand names: Circle Lens, Europa, Pacifica, Gothika and Water Color * Manufactured for Softlens Technology, Marietta, GA 30060.

    Recall: Z-1257-06 · Initiated May 10, 2006

    Recall

    Recall Number
    Z-1257-06
    Event Number
    35597
    Firm
    Hebron International, Inc.
    FEI Number
    3005746624
    Product Code
    LPL
    Status
    Terminated
    Root Cause
    Other
    Initiated
    May 10, 2006
    Posted
    July 26, 2006
    Terminated
    July 25, 2012
    Address
    5265 Buford Hwy., Atlanta, GA, 30340

    Description

    Soft Cosmetic Contact Lenses sold under the brand names: Circle Lens, Europa, Pacifica, Gothika and Water Color * Manufactured for Softlens Technology, Marietta, GA 30060.

    Reason

    Contact lenses were distributed and sold to inappropriate retail establishments without professional eye care involvement.

    Action

    Consignees were notified by certified mail on 05/22/2006.

    Distribution

    Nationwide

    Quantity

    334,187 lenses