BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LASIK

    MDR report key: 1230095 · Received November 12, 2008

    Report

    Report Number
    MW5008966
    Event Type
    Injury
    Date Received
    November 12, 2008
    Date of Event
    May 17, 2008
    Report Date
    November 12, 2008
    Product Code
    LZS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    APPROX 6 WEEKS AFTER LASIK SURGERY, I NOTICED THAT POINTS OF LIGHT AT NIGHT ARE DOUBLED -E.G., INSTEAD OF ONE RED TRAFFIC LIGHT, I SEE TWO-. SURPRISINGLY, I DON'T NOTICE MUCH OF THE HALOING AND STARBURSTING THAT ARE USUALLY DESCRIBED AS LASIK NIGHT VISION PROBLEMS. I HAVE ALSO NOTICED THAT I EXPERIENCE DOUBLE VISION IN MY RIGHT EYE DURING THE DAY TIME. THIS IS MOST NOTICEABLE WHEN TRYING TO READ A RULER OR TAPE MEASURE. ALL THE GRADUATION LINES ARE DOUBLED AND I HAVE TO CLOSE MY RIGHT EYE TO DETERMINE THE CORRECT MEASUREMENT. I HAVE ALSO NOTICED A DRAMATIC INCREASE IN THE NUMBER AND DENSITY OF THE VITREOUS OPACITITIES -FLOATERS- IN MY VISION. THIS INCREASE ALSO OCCURRED AT APPROX 6 WEEKS POST SURGERY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Required Intervention