BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN

    MDR report key: 1040888 · Received May 9, 2008

    Report

    Report Number
    MW5006807
    Event Type
    Injury
    Date Received
    May 9, 2008
    Date of Event
    June 1, 2001
    Report Date
    May 9, 2008
    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 PERFORMED BY A DR IN 2001. I WAS A HIGH HYPEROBE [OVER +6] AND SINCE THAT TIME HAVE SUFFERED FROM FLUCTUATION IN VISION [SEVERE FLUCTUATIONS] WHICH OCCUR DAY TO DAY, HOUR TO HOUR AND FROM MORNING TO NIGHT. I SUFFER FROM SIGNIFICANT PROBLEMS WITH GLARE, HAVE LOST CONTRAST SENSITIVITY, AND SEE STARBURSTS AND HALOS. I CANNOT DRIVE AT NIGHT UNLESS I KNOW THE AREA WELL, CANNOT READ MOST SIGNS DAY OR NIGHT, AND AM IN FACT A DANGER WHEN I DRIVE AT NIGHT, WHICH I ALMOST NEVER DO. THIS HAS HAD A NEGATIVE IMPACT ON THE QUALITY OF BOTH MY VISION AND MY LIFE. CONTACT DR'S OFFICE FOR MEDICAL RECORDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN LASIK LZS

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention