BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LASIK SURGERY

    MDR report key: 2348580 · Received November 20, 2011

    Report

    Report Number
    MW5023196
    Event Type
    Injury
    Date Received
    November 20, 2011
    Date of Event
    November 1, 2010
    Report Date
    November 20, 2011
    Manufacturer
    NA
    Product Code
    LZS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAVE CHRONIC DRY EYE SYNDROME. I STARTED HAVING ACUTE DRYNESS AND UNBEARABLE PAIN IN BOTH OF MY EYES FOUR MONTHS AFTER SURGERY. I WENT TO CHECK WITH THE SURGEON AND THE CLINIC. THEY SAID THAT THIS IS COMMON AND WILL GO AWAY OVER TIME. I WENT AGAIN AND AGAIN TO THEM WHENEVER I WAS SUFFERING, EACH TIME THEY SAID THAT THIS WAS NORMAL AND JUST ASKED ME TO CONTINUE PUTTING DROPS. IT IS ALMOST ONE AND HALF YEARS NOW AND I AM ACTUALLY WORSE. I RUSHED ONE DAY LAST MONTH TO THE (B)(6) SEEKING FOR DESPERATE HELP. THE DOCTOR WHO CHECKED ME SAID THAT THEY WERE NO LONGER LIABLE TO ATTEND TO ME SINCE I WAS PAST THE YEAR OF FOLLOW UP. I AM LEFT IN LIMBO. I AM PUTTING THESE STUPID DROPS EVERY 30 MINUTES NON-STOP BUT NOTHING SEEMS TO HELP. I AM A PROFESSIONAL STAGE SINGER AND GOT THIS LASIK DONE TO GET RID OF GLASSES, BUT NOW I AM NOT EVEN ABLE TO PERFORM WELL ON STAGE WITH THE BURNING IN MY EYES AND THE UNCOMFORTABLE FEELING. BY PUTTING DROPS, MY VISION IS ALSO AFFECTED. LAST BUT NOT THE LEAST, I CANNOT EVEN DO MY EYE MAKE-UP TO LOOK GOOD ON STAGE. BEFORE MY SURGERY, I NEVER HAD DRY EYES OR BURNING. NOW I AM ALWAYS FEELING FRUSTRATED AND MISERABLE WITH PUTTING THESE DROPS WITH NO RESULTS. MY EYES STILL HURT SO MUCH. THE DISCOMFORT OF SOMETHING IN MY EYE WHICH IS A COMMON SYMPTOM FOR DRY EYES IS SO UNCOMFORTABLE AND UNBEARABLE. I HAVE ALREADY SPENT SO MUCH MONEY TOWARDS THESE EYE DROPS. I AM REALLY FED UP AND NO DOCTORS WOULD HELP. ALL I HEAR FROM THEM IS THAT MY VISION IS GOOD, BUT NO ONE SEEMS TO HELP ME WITH THIS DRYNESS AND BURNING PAIN IN MY EYES. THIS IS NOT ABOUT A PRODUCT, BUT MY COMPLAINT IS ABOUT THE AFTERMATH OF LASIK SURGERY. EVEN NOW WHEN I AM ENTERING THIS FORM, I AM HAVING SO MUCH DIFFICULTY CONTINUING TO TYPE. MY EYES ARE BURNING LIKE HELL, SO MUCH PAIN. WHEN I AM WORKING AT MY OFFICE IN FRONT OF MY COMPUTER, I AM IN SO MUCH DISCOMFORT AND PAIN, THAT I LOOK FORWARD FOR THE DAY TO BE OVER SOON SO THAT I CAN GO HOME AND CLOSE MY EYES AND LIE DOWN. I AM UNABLE TO ENJOY LIFE THIS WAY. PLEASE HELP.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention