BEUDAMED
    FDA Recall Terminated

    Fancy i Color cosmetic lens, Contents: A pair of sterile soft color contact lens immersed in buffered isotonic saline solution, Size: B.C. 8.6mm DIA. 14.5mm. Dreamcon Co. LTD. Korea.

    Recall: Z-1756-2010 · Initiated May 17, 2010

    Recall

    Recall Number
    Z-1756-2010
    Event Number
    55807
    Firm
    Kim's Trading Inc
    FEI Number
    3008163473
    Product Code
    LPM
    Status
    Terminated
    Root Cause
    PMA
    Initiated
    May 17, 2010
    Posted
    June 4, 2010
    Terminated
    August 11, 2010
    Address
    509 Wyandotte St, Bethlehem, PA, 18015-1525

    Description

    Fancy i Color cosmetic lens, Contents: A pair of sterile soft color contact lens immersed in buffered isotonic saline solution, Size: B.C. 8.6mm DIA. 14.5mm. Dreamcon Co. LTD. Korea.

    Reason

    Recall is being conducted because the recalled color cosmetic contact lenses are unapproved medical devices.

    Action

    Kim's Trading Inc. verbally contacted the distributor to provide notification of the recall. All affected product was to be properly disposed. For further information, contact Kim's Trading Inc. at 1-484-895-3773.

    Distribution

    All product was distributed to one distributor in the Bethlehem PA area.

    Quantity

    300 pairs of contact lens