BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISX EXCIMER LASER

    MDR report key: 1931611 · Received December 7, 2010

    Report

    Report Number
    3006695864-2010-00136
    Event Type
    Injury
    Date Received
    December 7, 2010
    Date of Event
    October 26, 2010
    Report Date
    November 9, 2010
    Manufacturer
    AMO MANUFACTURING USA LLC
    Product Code
    LZS
    PMA / PMN Number
    K000327
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EQUIPMENT SERVICE WAS NOT REQUESTED BY THE CLINIC. AN AMO CLINICAL SUPPORT SPECIALIST DISCUSSED THE EVENT WITH THE CLINIC AND THEY REPORTED THAT THEY BELIEVE THE PT MOVED UNDER THE LASER. NO FURTHER INFO IS AVAILABLE.

    Description of Event or Problem · 1

    THE DR REPORTED THAT A PT TREATED FOR LASIK VISION CORRECTION PRESENTED AT THE FIVE DAY POST OP EXAMINATION WITH DECREASED VISION AND A POSSIBLE CENTRAL ISLAND IN THE RIGHT EYE (OD) AND CENTRAL STEEPENING IN THE LEFT EYE (OS). THE PT'S POST OP VISUAL ACUITY IS OD: 20/30 AND OS: 20/25. IT IS NOT KNOWN IF THIS IS BEST CORRECTED OR UNCORRECTED VISUAL ACUITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VISX EXCIMER LASER LZS AMO MANUFACTURING USA LLC STAR S4 IR, CE

    Patients

    Seq Age Sex Outcome Treatment
    1 Other