BEUDAMED
    FDA Recall Terminated

    SOLO-care Plus with Aqualube, Multi-purpose solution*** AquaSoft (Private label), Multi-purpose solution***Sterile***For soft lenses, CIBA Vision Corporation, Made in Canada, Assembled in Canada, Manufactured for: CIBA Vision Corporation, Duluth, GA 30097 USA. The product is distributed in units of single or twin packs containing 2 to 12 ounces of product.

    Recall: Z-0028-05 · Initiated September 27, 2004

    Recall

    Recall Number
    Z-0028-05
    Event Number
    30159
    Firm
    Ciba Vision Corporation
    FEI Number
    1053053
    Product Code
    LPN
    Status
    Terminated
    Root Cause
    Other
    Initiated
    September 27, 2004
    Posted
    October 21, 2004
    Terminated
    August 22, 2005
    Address
    11460 Johns Creek Pkwy, Duluth, GA, 30097-1518

    Description

    SOLO-care Plus with Aqualube, Multi-purpose solution*** AquaSoft (Private label), Multi-purpose solution***Sterile***For soft lenses, CIBA Vision Corporation, Made in Canada, Assembled in Canada, Manufactured for: CIBA Vision Corporation, Duluth, GA 30097 USA. The product is distributed in units of single or twin packs containing 2 to 12 ounces of product.

    Reason

    Stability tests at 24 months revealed failing results for disinfection efficacy.

    Action

    Consignees were notified by letter on 10/01/2004.

    Distribution

    Nationwide, Canada, Latin America, Europe, Thailand, South Africa and Asia.

    Quantity

    5,913,120 units