BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KKK

    MDR report key: 1037817 · Received May 1, 2008

    Report

    Report Number
    MW5006596
    Event Type
    Malfunction
    Date Received
    May 1, 2008
    Date of Event
    January 6, 2006
    Report Date
    May 1, 2008
    Product Code
    LZS
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAD LASIK LASER EYE SURGERY. WHEN THE PROCEDURE WAS BEING DONE, THE FLAP THAT WAS CUT ON MY LEFT EYE WAS VERY THIN. THEN, THE COMPUTER ON THE LASER MACHINE CRASHED. IT TOOK A FEW MINUTES TO RE-BOOT. WHILE RE-BOOTING, THE DOCTOR TRIED TO KEEP MY EYE SATURATED WITH FLUIDS. HOWEVER, WHEN THE VERY THIN FLAP WAS REPLACED, IT HAD A WRINKLE IN IT. THE WRINKLE CAUSED BLURRY VISION IN A STARRY PATTERN. I HAD A SECOND SURGERY DONE TO SMOOTH OUT THE WRINKLE, AND IT HELPED, BUT THE VISION IN THAT EYE WILL ALWAYS BE A BIT BLURRY. ALSO, AN OVERALL CONSEQUENCE OF LASIK THAT I WAS NOT ADEQUATELY INFORMED OF BEFORE THE SURGERY IS DRY EYES. IT IS ESPECIALLY DIFFICULT OVERNIGHT, AND ESPECIALLY IF I'VE HAD A ALCOHOL TO DRINK BEFORE GOING TO BED. I CAN DETECT A DRYING OF EYES AFTER JUST ONE GLASS OF WINE. SOMETIMES MY EYES GET SO DRY OVERNIGHT THAT I WAKE UP WITH INCREDIBLE STINGING EYES IN THE MIDDLE OF THE NIGHT. I KEEP DROPS ON MY NIGHTSTAND SO THAT I CAN IMMEDIATELY PUT DROPS IN MY EYES WHEN I WAKE UP. I REACH FOR THE DROPS WITH MY EYES CLOSED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1