BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISX LASER

    MDR report key: 1033959 · Received April 24, 2008

    Report

    Report Number
    MW5006394
    Event Type
    Injury
    Date Received
    April 24, 2008
    Date of Event
    March 28, 2003
    Report Date
    April 24, 2008
    Manufacturer
    VISX
    Product Code
    LZS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    LASIK - INDUCED KERATOCONJUNCTIVITIS_SICCA - DRY EYE SYNDROME- AND LASIK - INDUCED HIGH ORDER ABERRATIONS, WHICH RESULTED IN A LOSS OF NORMAL CONTRAST SENSITIVITY DURING THE DAY AND IN DIM LIGHT AND AT NIGHT I HAVE GHOSTING, STAR-BURSTING AND HALOS. I AM UNABLE TO DRIVE AT NIGHT. WHILE I HAD 20/20 VISUAL ACUITY, THE QUALITY OF MY VISION HAS BEEN GREATLY REDUCED AS REFLECTED BY THE CORNEAL TOPOGRAPHY AND WAVEFRONT ABERROMETRY. THE DRY EYE MEANS MY EYES ARE CONSTANTLY UNCOMFORTABLE AND I CAN'T USE MY EYES AS MUCH. DATE OF LASIK IN 2003. DIAGNOSIS OR REASON FOR USE: REFRACTIVE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VISX LASER NONE LZS VISX

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR