BEUDAMED
    FDA Recall Terminated

    IDEAL SOFT (polymacon) Hydrophic contact lens, 62% poly (2-hydroxyethlymethacrytate). 38% water immersed in 0.9% sodium chloride solution. One sterile, Manufactured by: Ideal Optics, Inc., Atlanta, GA 30339.

    Recall: Z-0221-05 · Initiated October 12, 2004

    Recall

    Recall Number
    Z-0221-05
    Event Number
    30310
    Firm
    Ideal Optics, Inc.
    FEI Number
    1042064
    Product Code
    LPL
    Status
    Terminated
    Root Cause
    Other
    Initiated
    October 12, 2004
    Posted
    November 25, 2004
    Terminated
    May 18, 2006
    Address
    2255 Cumberland Pkwy Se, Ste 500, Atlanta, GA, 30339-4524

    Description

    IDEAL SOFT (polymacon) Hydrophic contact lens, 62% poly (2-hydroxyethlymethacrytate). 38% water immersed in 0.9% sodium chloride solution. One sterile, Manufactured by: Ideal Optics, Inc., Atlanta, GA 30339.

    Reason

    Lenses may not be sterile.

    Action

    Consignees were notified by letter on 10/13/2004. A second letter was sent out on 11/8/2004 with addtional lots.

    Distribution

    AL, GA, NC, NY, SC, VA

    Quantity

    1764 vials