BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LASIK

    MDR report key: 1080832 · Received July 24, 2008

    Report

    Report Number
    MW5007737
    Event Type
    Injury
    Date Received
    July 24, 2008
    Date of Event
    September 30, 2005
    Report Date
    July 24, 2008
    Product Code
    LZS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    RPTR REPORTS THAT HE HAD LASER SURGERY IN 2005 AND NOW HE HAS DOUBLE AND BLURRING VISION AND HAS TO USE MANY EYEDROPS. REPORTER STATES THAT DR WILL NOT SEE HIM, OR HONOR THE WARRANTY THAT HE HAS. IN OCT 2006 RPTR STATES THAT HE HAD TO HAVE PLUGS INSERTED FOR DRY EYES AND SAW A SPECIALIST AND WAS TOLD HE HAD A REFRACTION AND HIS EYE WAS THE SHAPE OF A FOOTBALL. IN 2008, PT HAD "LASIK SURGERY TOUCH UP". RPTR STATES THAT HE HAD 7 F/U VISITS AND WAS TOLD THAT HE HAD SCAR TISSUE AND AN ASTIGMATISM AND WOULD HAVE TO WEAR AN EYE PATCH ON HIS RIGHT EYE. PT STATES THAT HE NOW HAS TO HAVE GLASSES TO SEE AFTER PAYING THOUSANDS OF DOLLARS FOR LASIK SURGERY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR