BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NA

    MDR report key: 1584204 · Received January 16, 2010

    Report

    Report Number
    MW5014409
    Event Type
    Injury
    Date Received
    January 16, 2010
    Date of Event
    January 5, 2005
    Report Date
    January 16, 2010
    Manufacturer
    NA
    Product Code
    LZS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAVE DEBILITATING COMPLICATIONS FROM LASIK SURGERY. SEVERE AND CONSTANT EYE PAIN, SEVERE DRY EYE, MY EYES NOW HAVE SEVERE REACTIONS TO WIND, AIR, HEAT OR AIR CONDITIONING, AND I CAN NOT WEAR MAKEUP AS THE DUST/FUMES CREATE PAIN AND TEARING. I AM UNABLE TO SPEND PROLONGED TIME AT A COMPUTER SCREEN OR READ WITHOUT SUFFERING EYE PAIN. I AM UNABLE TO WORK OUTSIDE THE HOME BECAUSE OF THESE ISSUES. MY LIFE HAS BEEN CHANGED FOR THE WORSE DUE TO THE SURGERY. I SUFFER FROM FIBROMYALGIA-AND DID AT THE TIME OF THE SURGERY-AND MOST LIKE UNDIAGNOSED DRY EYE. THE POTENTIAL COMPLICATIONS OF THE SURGERY WERE NOT MADE CLEAR, AND THERE WAS SURELY NOT SUFFICIENT SCREENING CONSIDERING MY PRE-EXISTING CONDITIONS. THE WHOLE PROCESS IN THE DOCTOR OFFICE WAS UNLIKE A MANUFACTURING PRODUCTION LINE ATMOSPHERE. FROM THE INTERVIEW TO THE ACTUAL PROCESS, IT WAS UNLIKE ANY OTHER SURGERY. VERY PRODUCTION/THROUGH PUT ORIENTED AT ALL LEVELS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention