BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NA

    MDR report key: 1577588 · Received January 9, 2010

    Report

    Report Number
    MW5014290
    Event Type
    Injury
    Date Received
    January 9, 2010
    Date of Event
    January 2, 2006
    Report Date
    January 9, 2010
    Manufacturer
    NA
    Product Code
    LZS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I UNDERWENT LASIK EYE SURGERY IN 2006. SINCE THE SURGERY, I HAVE SUFFERED FROM A NUMBER OF SEVERE COMPLICATIONS, AND MY VISION IS NOW PERMANENTLY DAMAGED. MY VISION PROBLEMS, SINCE THE SURGERY, NONE OF WHICH WERE PRE-EXISTING INCLUDE DOUBLE VISION, HALOS AND STARBURSTS ON ANY LIGHT SOURCE IN A LOW-LIGHT SITUATION, SIGNIFICANTLY REDUCED CONTRAST SENSITIVITY - ESPECIALLY IN LOW-LIGHT SITUATIONS-, AND CHRONIC HEADACHES FROM EYE STRAIN. THE SURGERY WAS PERFORMED BY A DR. FOLLOW-UP SURGERIES WERE PERFORMED ON EACH EYE IN A FAILED ATTEMPT TO CORRECT MY PROBLEMS. AFTER DEALING WITH THESE ISSUES FOR TWO YEARS, I WAS INSTRUCTED BY THE DOCTOR TO SIMPLY WAIT FOR THEM TO CLEAR UP, WHICH STILL HASN'T HAPPENED -IT'S NOW BEEN MORE THAN FOUR YEARS SINCE THE ORIGINAL SURGERY-. I FINALLY GAVE UP ON TRYING TO CONVINCE DR AND HIS STAFF THAT I HAD SIGNIFICANT VISION PROBLEMS; THEY SEEMED CONVINCED THAT IT WAS EITHER ALL IN MY HEAD OR SOMETHING THAT WOULD RESOLVE ITSELF EVENTUALLY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Required Intervention