BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LZS

    MDR report key: 1135383 · Received August 25, 2008

    Report

    Report Number
    MW5008096
    Event Type
    Injury
    Date Received
    August 25, 2008
    Date of Event
    June 8, 2006
    Report Date
    August 25, 2008
    Manufacturer
    INTRALASE LASER
    Product Code
    LZS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    FOR THE FIRST 2 WEEKS AFTER LASIK, MY EYES FELT A LITTLE DRY, BUT OVERALL GOOD. HOWEVER, OVER THE NEXT FEW WEEKS, THE DRYNESS KEPT GETTING WORSE. BY WEEK 6, I HAD SEVERE LASIK INDUCED NERVE DAMAGE DRY EYES. MY EYES WERE BONE DRY AND THE PAIN WAS UNBEARABLE FOR THE FIRST 10 MONTHS POST-LASIK. I COULD FEEL THE PAIN WITH EVERY BLINK OF EVERY DAY. EVEN CLOSING MY EYES PROVIDED MINIMAL RELIEF. ALL THE EYE DOCTORS COULD DO WAS TELL ME TO KEEP USING ARTIFICIAL TEARS, PUT ME ON RESTASIS, AND PUT PLUGS IN MY PUNCTA -THE DRAINS OF THE EYE-. THESE THINGS PROVIDED MINIMAL RELIEF. THE PAIN WAS SO INTENSE WITH SO LITTLE RELIEF FROM EXISTING THERAPIES THAT I FOUND MYSELF RESEARCHING SUICIDE OPTIONS ON THE INTERNET. PRIOR TO LASIK, I WAS A HAPPY FAMILY MAN WITH A GOOD JOB. TO THINK THAT I COULD FIND MYSELF IN THIS TYPE OF POSITION BECAUSE OF LASIK, AN UNNECESSARY FDA APPROVED PROCEDURE, WAS BEYOND BELIEF. I AM NOW OVER 2 YEARS POST-LASIK AND I SUFFER FROM SENSELESS, PERMANENT DISABILITIES INCURRED FROM LASIK. THERE ARE MANY THINGS THAT I NO LONGER CAN DO SUCH AS BEING IN A ROOM WITH MOVING AIR FROM CEILING FANS, HEATING VENTS, OR AIR CONDITIONING. I CAN ONLY WORK LIMITED HOURS DUE TO THE CHRONIC POST-LASIK PAIN THAT I ENDURE. I SUFFER FROM CHRONIC EYE PAIN THAT INTENSIFIES AS THE DAY GOES ON. I WOULD WRITE MORE BUT I DON'T THINK ANYONE IN THE FDA WHO HAS ANY DECISION MAKING AUTHORITY READS THESE REPORTS BECAUSE IF THEY DID, I WOULD EXPECT THAT THEY WOULD FEEL A SHOCK TO THEIR CONSCIENCE THAT THE FDA CONTINUES TO ALLOW PEOPLE'S EYES AND LIVES TO BE RUINED BY LASIK, A SENSELESS, NON-MEDICALLY NECESSARY PROCEDURE. I'VE HEARD LASIK PHYSICIANS COMPARE LASIK TO OTHER COSMETIC PROCEDURES. THAT'S ABSURD! IF SOMEBODY HAS A POOR OUTCOME WITH BREAST AUGMENTATION, THEY CAN STILL GO TO WORK AND/OR DRIVE AT NIGHT. A PERSON'S EYES ARE THEIR MOST VITAL SENSORY ORGAN. IF YOU DAMAGE A PERSON'S EYES, YOU DAMAGE THAT PERSON IN THE MOST SIGNIFICANT WAY. WHILE IT'S TOO LATE FOR ME AND MANY OTHERS, IT'S NOT TOO LATE FOR FUTURE LASIK PTS. I REQUEST THAT THE FDA SERVE THE PUBLIC THAT YOU ARE ENTRUSTED TO PROTECT RATHER THAN SERVING THE LASIK INDUSTRY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LZS INTRALASE LASER LZS INTRALASE LASER

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Required Intervention