BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LASIK LASER ASSISTED IN-SITU KERATOMILEUSIS

    MDR report key: 1033943 · Received April 24, 2008

    Report

    Report Number
    MW5006390
    Event Type
    Injury
    Date Received
    April 24, 2008
    Date of Event
    November 28, 2006
    Report Date
    April 24, 2008
    Product Code
    LZS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    DC, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I LEARNED ON THE LOCAL NEWS ABOUT THE FDA HEARING ON LASIK TOMORROW. I HAVE HAD AN ADVERSE EVENT RELATED TO MY LASIK AND DID NOT KNOW THERE WAS A FORUM TO COMPILE DATA LIKE MINE UNTIL NOW. SO I WANTED TO REPORT IT SO THAT THE FDA COULD HAVE MORE COMPLETE INFORMATION ON THE OUTCOMES OF THE PROCEDURE. IN 2006, I HAD LASIK PERFORMED ON BOTH EYES AT A FACILITY. MY DOCTOR PERFORMED THE SURGERY AND BOTH FACILITY AND DR. SAID THAT I WAS A VERY GOOD CANDIDATE FOR THE SURGERY. BY ALL REPORTS, THE SURGERY WENT WELL. WITHIN A WEEK AFTER SURGERY, MY EYESIGHT WAS 20/20 AND I WAS VERY PLEASED WITH THE RESULTS, BUT AFTER I STOPPED USING THE MANDATORY ANTIBIOTIC EYEDROPS, MY EYES BECAME SEVERELY DRY. I LITERALLY WOULD WAKE UP IN THE MIDDLE OF THE NIGHT WITH MY EYEBALLS STUCK TO MY EYELID AND I COULDN'T OPEN MY EYES. IT'S BEEN A PROBLEM EVER SINCE AND I STILL HAVE TO USE RESTASIS 2X PER DAY, WHICH I CAN'T SAY HAS HELPED VERY MUCH. IN ADDITION, MY EYESIGHT HAS DETERIORATED TO 20/50 AND I HAVE TO WEAR GLASSES AGAIN. I'M TOLD THAT IT WAS THE WAY I HEALED THAT CAUSED THE DETERIORATION IN SIGHT. IN ADDITION, IN MY RIGHT EYE, WHICH WAS THE MOST CORRECTED, I HAVE CONTINUED TO HAVE A DULL ACHE OR SORENESS THAT REMAINS. MY DOCTOR CAN'T EXPLAIN THAT PART.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LASIK LASER ASSISTED IN-SITU KERATOMILEUSIS LZS

    Patients

    Seq Age Sex Outcome Treatment
    1 Other