BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISX S4 LASER

    MDR report key: 1081413 · Received July 23, 2008

    Report

    Report Number
    MW5007786
    Event Type
    Injury
    Date Received
    July 23, 2008
    Date of Event
    August 29, 2003
    Report Date
    July 23, 2008
    Manufacturer
    VISX
    Product Code
    LZS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    LASIK ENHANCEMENT, 2 MORE SUBSEQUENT ENHANCEMENTS, IRREGULAR ASTIGMATISM. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED? 1. NO, 2. NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VISX S4 LASER STAR S4 IR LASER LZS VISX

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention