BEUDAMED
    FDA Adverse Event Other Summary report: N

    DON'T KNOW

    MDR report key: 1052148 · Received May 24, 2008

    Report

    Report Number
    MW5007027
    Event Type
    Other
    Date Received
    May 24, 2008
    Date of Event
    October 31, 2007
    Report Date
    May 24, 2008
    Manufacturer
    DON'T KNOW
    Product Code
    LZS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THE DATE OF THE "EVENT" IS THE MOMENT OF REALIZATION OF THE PROBLEM, NOT THE DATE THE LASIK OCCURRED. I HAD LASIK PERFORMED ABOUT 10 YEARS AGO BY A DR. MY VISION WAS EXCELLENT IMMEDIATELY, BUT BEGAN DETERIORATING AND I WENT IN FOR A REDO ON ONE EYE A LITTLE OVER A YEAR LATER. MY VISION CONTINUED TO DECLINE AND I LEARNED, IT WAS NOT CORRECTABLE BY GLASSES. I REALIZED A FEW YEARS AGO THAT I WAS SEEING TRIPLE, BUT DIDN'T KNOW WHY. I DIDN'T PUT IT TOGETHER WITH LASIK UNTIL 2007 SURFING ON THE INTERNET. THE MEDICAL FORUM TALKED ABOUT A PT WHOSE TRIPLOPIA WAS CAUSED BY LASIK. THEN I MET AN OPTOMETRIST WHO WAS FAMILIAR WITH TRIPLOPIA. HE EXAMINED ME AND CONFIRMED HE COULDN'T DO ANYTHING. HE SUGGESTED GETTING LEGAL REPRESENTATION BUT I DON'T HAVE THE MONEY TO DO SO. HE TOLD ME I WILL NOT BE ABLE TO PASS A DMV EYE CHART EXAM. I DIDN'T THINK THERE WAS ANYTHING I COULD DO. THEN MY DAUGHTER HEARD ON NPR THAT THE FDA IS LOOKING INTO LASIK ISSUES AND THAT'S HOW I GOT HERE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DON'T KNOW LASIK LZS DON'T KNOW DONT' KNOW

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other DON'T KNOW