BEUDAMED
    FDA Recall Terminated

    Opthalmic Laser, product number 8065-5000-1

    Recall: Z-0923-04 · Initiated April 9, 2004

    Recall

    Recall Number
    Z-0923-04
    Event Number
    28883
    Firm
    Alcon Research, Ltd.
    Product Code
    HQF
    Status
    Terminated
    Root Cause
    Other
    Initiated
    April 9, 2004
    Posted
    July 20, 2004
    Terminated
    August 30, 2004
    Address
    6201 South Freeway Fort, Worth, TX, 76134-2099

    Description

    Opthalmic Laser, product number 8065-5000-1

    Reason

    Product may generate laser light flashback.

    Action

    Additional in-service training materials have been prepared and will be delivered to users. Additional software upgrade will be made. Actvities will be complete in May 2004.

    Distribution

    Nationwide and Sweden, Taiwan, Fiji Islands, Cyprus, Philippines.

    Quantity

    62