BEUDAMED
    FDA Recall Terminated

    AMO VISX STAR Excimer Laser System, manufactured by VISX, Santa Clara, CA 95051

    Recall: Z-1139-2008 · Initiated December 13, 2007

    Recall

    Recall Number
    Z-1139-2008
    Event Number
    46393
    Firm
    VISX INCORPORATED, A SUBSIDIARY OF AMO INC
    FEI Number
    1221842
    Product Code
    LZS
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    December 13, 2007
    Posted
    June 5, 2008
    Terminated
    May 5, 2010
    Address
    3400 Central Expressway, Santa Clara, CA, 95051

    Description

    AMO VISX STAR Excimer Laser System, manufactured by VISX, Santa Clara, CA 95051

    Reason

    Firm received two complaints (including one injury complaint) associated with the movement of the VISX chair while in the patient loading ("fully swung out" unlocked) position under an IntraLase FS laser.

    Action

    On December 13, 2007, firm issued an Urgent Safety Notice to all VISX and IntraLase laser owners related to recall. The Safety Notice contains information related to the measures that can be taken to prevent unintentional movement of any chair during other procedures. AMO is initiating a field corrective action, whereby Field Service Engineers will visit each practice that owns both systems to disable the VISX chair back switch. For additional information, please contact AMO at (714) 247-8656.

    Distribution

    Worldwide Distribution - USA, including the states of: AK AL AR AZ CA CO CT DC DE FL GA HI IA ID IL IN KS KY LA MA MD MI MN MO MS MT NC ND NE NH NJ NM NV NY OH OK OR PA PR RI SC SD TN TX UT VA VT WA WI WV and countries of: Argentina Australia Austria Bahrain Belgium Bolivia Brazil Bulgaria Canada Chile China Colombia Costa Rica Cyprus Czech Republic Djibouti Dominican Rep. Ecuador Egypt Finland France Germany Great Britain Greece Hong Kong India Indonesia Ireland Israel Italy Japan Jordan Kasachstan Kuwait Lebanon Malaysia Martinique Mexico Mongolia Netherlands New Zealand Norway Oman Pakistan Paraguay Philippines Poland Portugal Russian Fed. Saudi Arabia Singapore Slovakia South Africa South Korea Spain Sweden Switzerland Taiwan Thailand Trinidad,Tobago Turkey Unit.Arab Emir. Venezuela Vietnam

    Quantity

    1,853 units