BEUDAMED
    FDA Adverse Event Other Summary report: N

    LASIK

    MDR report key: 1033975 · Received April 24, 2008

    Report

    Report Number
    MW5006401
    Event Type
    Other
    Date Received
    April 24, 2008
    Date of Event
    January 20, 2007
    Report Date
    April 24, 2008
    Product Code
    LZS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    SC, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I WENT TO DR AND HAD LASIK SURGERY I EARLY 2007 FOR CORRECTIVE EYE SURGERY. I HAD SOME DRY EYE BEFORE SURGERY, BUT NOW IT IS SEVERE. I WENT IN 2008 AFTER A YR TO HAVE SOMETHING DONE ABOUT DRY EYE AT THE APPT. I WAS TOLD I HAVE 0 TEARS IN MY LEFT EYE, AND VERY FEW TEARS IN MY RIGHT EYE. HE PRESCRIBED RESTASIS AND OVER THE COUNTER DROPS. THIS DOES HELP ON SOME DAYS. AFTER THE APPT, I WAS TOLD THERE WAS NO CHARGE,THEN THEY STATED SENDING ME BILLS. I CALLED MANY TIMES TO CLEAR THIS UP AND THEY KEEP SAYING IT IS BEING REVIEWED. I POSTED THE FOLLOWING LETTER ON THEIR WEBSITE IN ORIGINAL MONTH. ENTER YOUR STORY HERE. I HAD THE LASIK SURGERY THE SAME MONTH. PLEASE BE AWARE, IF YOU HAVE MODERATE DRY EYES YOU WILL BE SORRY IF YOU HAVE THIS SURGERY. MY VISION IS SO BLURRY AT NIGHT, THEY SAID THE HALOS AROUND LIGHTS WOULD IMPROVE WITHIN A FEW MONTHS TO A YEAR. THEY HAVE ONLY GOTTEN WORSE. I DID NOT HAVE HALOS AROUND LIGHTS BEFORE THIS SURGERY, AND IT HAS CONTINUED TO GET WORSE AS THE YEAR PROGRESSED.AS THE YEAR HAS PROGRESSED. DRY/RED EYES. OH MY, IT IS TERRIBLE. I PUT DROPS IN MY EYES EVERY COUPLE OF HRS, AT NIGHT AND NOTHING SEEMS TO HELP. I CALLED - AFTER GIVING IT A YR TO CLEAR UP - ONLY TO BE TOLD THAT THE 6 MONTHS WAS OVER AND I WOULD HAVE TO PAY FOR AN EYE EXAM, THEN FOR ANYTHING EXTRA THAT NEEDS TO BE DONE. I DID COME IN SEVERAL TIMES AFTER THE SURGERY AND HAD SOMETHING PUT IN MY TEAR DUCTS TO HELP WITH THE DRYNESS. I WAS ALWAYS TOLD TO GIVE IT A YR, WELL HERE I AM A YR LATER, AND MY EYES ARE IN BAD SHAPE, THEY HURT ALL DAY AND ARE SO RED. OF COURSE, THEY HAVE MY VISITS DOCUMENTED AND THE YRS UP. I COULD UNDERSTAND THE CHARGE IF I WOULD HAVE NEVER GONE BACK OR CALLED, BUT THAT IS NOT THE CASE AT ALL. I EVEN PAID UP FRONT AND DID NOT MAKE PAYMENTS. I AM JUST AN ORDINARY PERSON, NOT ONE OF THE MANY ADVERTISED "HIGH PROFILE" PEOPLE ON THE WALLS OF THE EYE CTR. ALTHOUGH, THE DOCTOR AND STAFF HAVE TRIED THE FIRST 6 MONTHS, I AM NOT AT ALL HAPPY WITH HAVING THE SURGERY. MOST OF WHAT I WAS TOLD IS TRUE, READING VISION WOULD BE WORSE, I UNDERSTOOD THAT-BUT NEVER, NEVER WAS I WARNED PRIOR TO THE SURGERY ABOUT "DRY EYE." PEOPLE NEED TO HEAR ABOUT THESE STORIES, EVEN IF THE DROPS ETC. I DO NOT FEEL LIKE I WAS PROPERLY TAKEN CARE OF, AND I SHOULD NOT BE RESPONSIBLE FOR PAYING FOR MEDS, APPT., ETC. PLEASE HELP.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Other