BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISX STAR S4 IR EXCIMER LASER

    MDR report key: 1003748 · Received February 22, 2008

    Report

    Report Number
    1221842-2008-00001
    Event Type
    Malfunction
    Date Received
    February 22, 2008
    Date of Event
    January 24, 2008
    Report Date
    January 24, 2008
    Manufacturer
    ADVANCED MEDICAL OPTICS - SANTA CLARA
    Product Code
    LZS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    FOLLOWING A CUSTOM MYOPIC LASIK PROCEDURE AN UNUSUAL SPOT PATTERN WAS OBSERVED IN THE PT'S OPERATIVE EYE AT THE 3:00 O'CLOCK POSITION OF THE ABLATION. CORNEAL TOPOGRAPHY APPEARS IRREGULAR. PATIENT IS SLOWLY IMPROVING VISUALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VISX STAR S4 IR EXCIMER LASER EXCIMER LASER LZS ADVANCED MEDICAL OPTICS - SANTA CLARA STAR S4 IR NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other