BEUDAMED
    FDA Recall Terminated

    Private Eyes, Diam 14.0 BC 8.6, Contents: one sterile daily wear soft contact lenses, 38% water, 62% polymacon, immersed in 0.9% buffered saline solution USP, Manufactured by Soft Lens Technology, Lot BB43 Expiration Date 08/06, Cosmetic Use Daily Wear ***Decorative Theatrical Contact Lenses, packed in vials labeled sterile. Types include: Zombie, Banshee, Green Leaf, Green Reptile, White Cat, Manson, Green Rave, Moon & Stars, Blackwolf, Fire, Black Out, Pink Rave, Spiral, Flower Power, Starfire, Yellow Cat Eye, Computer Chip, Target, Red Cat, Blue Rave, Smiley, White Snowflake and Red Vampire..

    Recall: Z-1313-04 · Initiated June 7, 2004

    Recall

    Recall Number
    Z-1313-04
    Event Number
    29281
    Firm
    The Contact Lens Store, Inc.
    FEI Number
    3004572109
    Product Code
    LPL
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 7, 2004
    Posted
    August 5, 2004
    Terminated
    September 16, 2004
    Address
    638 Church Street, Marietta, GA, 30060

    Description

    Private Eyes, Diam 14.0 BC 8.6, Contents: one sterile daily wear soft contact lenses, 38% water, 62% polymacon, immersed in 0.9% buffered saline solution USP, Manufactured by Soft Lens Technology, Lot BB43 Expiration Date 08/06, Cosmetic Use Daily Wear ***Decorative Theatrical Contact Lenses, packed in vials labeled sterile. Types include: Zombie, Banshee, Green Leaf, Green Reptile, White Cat, Manson, Green Rave, Moon & Stars, Blackwolf, Fire, Black Out, Pink Rave, Spiral, Flower Power, Starfire, Yellow Cat Eye, Computer Chip, Target, Red Cat, Blue Rave, Smiley, White Snowflake and Red Vampire..

    Reason

    The contact lenses were repacked in vials that were not sterile as indicated on the vial labeling.

    Action

    Consignees were first contacted by telephone with a f/u letter sent 6/7/2004

    Distribution

    MA, TX, WA.

    Quantity

    618 vials