BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVELIGHT ALLEGRETTO WAVEZ EXCIMER LASER SYSTEM

    MDR report key: 2021735 · Received March 11, 2011

    Report

    Report Number
    MW5019804
    Event Type
    Injury
    Date Received
    March 11, 2011
    Date of Event
    February 1, 2006
    Report Date
    March 11, 2011
    Manufacturer
    LIGHT LASER TECHNOLOGIE AG
    Product Code
    LZS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAD LASIK SURGERY IN (B)(6) 2006 AND I HAVE BEEN STRUGGLING WITH COMPLICATIONS SINCE. BEFORE MY SURGERY I WAS ASSURED I HAD < 1% CHANCE OF HAVING GASH OR ANY OTHER LONG TERM COMPLICATIONS. I NOTED THIS ON MY CONSENT FORM. PRIOR TO THE SURGERY I TOLD THE SURGEON I HAVE A VERY LOW TOLERANCE FOR A BAD OUTCOME AND GASH. HE REPEATEDLY TOLD ME "PUPIL SIZE IS NOT A GOOD PREDICTOR OF POOR POST LASIK NIGHT VISION." HE ASSURED ME THAT AS A "COMPATRIOT" HE WOULD TAKE GOOD CARE OF ME AND THAT I "WOULD DO FINE." IMMEDIATELY FOLLOWING SURGERY, I DEVELOPED DRY EYE WHICH IS WORSENING. I DEVELOPED ALL THE GASH SYMPTOMS EVEN THOUGH I WAS TOLD I HAD < 1% CHANCE OF HAVING ANY LONG TERM COMPLICATIONS. THE POSSIBILITY OF DRY EYE WAS NEVER DISCUSSED WITH ME. THE ONLY COMPLICATIONS WE DISCUSSED WERE GASH BECAUSE I INITIATED. AFTER COMPLAINING ABOUT DRY EYE MY SURGEON TOLD ME I HAD DRY EYE BEFORE SURGERY. I THOUGHT THIS WAS A CONTRAINDICATION FOR LASIK. OTHER CONTRAINDICATIONS FOR LASIK: PRE-EXISTING DRY EYE, OCCUPATION -COMPUTER PROGRAMMER-, LARGE PUPILS, HIGH CORRECTION, ASTIGMATISM, MEDICATIONS, LONG TERM CONTACT LENS USE AND POSSIBLY CATARACTS. I HAVE BEEN SEEING THE SURGEON THE ENTIRE TIME FOR FOLLOW UPS, GASH, DRYNESS AND CATARACTS WITH NO RESOLUTION IN SIGHT. THIS HAS SEVERELY IMPACTED MY LIFE TO THE POINT WHERE MY 3 YR RELATIONSHIP WITH MY FIANCE ENDED. I AM FINDING IT VERY DIFFICULT TO CONCENTRATE/WORK AND I HAVE BECOME DEPRESSED AS NOTHING HELPS AND THE DRS ARE STUMPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WAVELIGHT ALLEGRETTO WAVEZ EXCIMER LASER SYSTEM WAVELIGHT ALLEGRETTO WAVEZ EXCIMER LASER SYSTEM LZS LIGHT LASER TECHNOLOGIE AG NA

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Life Threatening| R AZASITE| LEXAPRO 20 MG/DAY| KLONOPIN 1 MG/DAY| REMERON 30 MG/DAY| EYE DROP OF ALL SORTS| HYDROCORTISONE CREAM| CELEXA 40 MG/DAY| KLONOPIN .5 MG/DAY| DOXYCYCLENE| ALPHAGAN| LID HYGIENE/SCRUBS| REMERON 15 MG/DAY| PILOCARPINE| LOTEMAX