BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXCIMER, LASER SYSTEM

    MDR report key: 8600559 · Received May 9, 2019

    Report

    Report Number
    MW5086548
    Event Type
    Injury
    Date Received
    May 9, 2019
    Date of Event
    August 1, 2012
    Report Date
    May 7, 2019
    Manufacturer
    UNK
    Product Code
    LZS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    BEFORE 1995, I HAD 20/600 VISION. I HAD RK IN 1995 (8 CUTS TO EACH EYE WITH AN ASTIGMATISM). ON (B)(6) 2012, I NOTICED THAT I NEEDED READERS, BUT THEY WERE NOT EFFECTIVE. I VISITED SEVERAL EYE DRS. SINCE, I VISITED EACH DR AT A DIFFERENT TIME OF THE DAY, I ENDED UP WITH SEVERAL PRESCRIPTIONS (ALL DIFFERENT). FOR PRICE AND CONVENIENCE REASONS, I ONLY FILLED 3 OF THE PRESCRIPTIONS. I CHANGE GLASSES DURING THE DAY. BESIDES THE PROBLEM WITH CHANGING, FINDING GLASSES, FLUCTUATING VISION, ETC. I NEVER SEE WELL, BUT AS A TEACHER WITH A NEED FOR DISTANCE AND CLOSE-UP VISION, IT'S A HUGE PROBLEM. RK KNIFE/SURGERY. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    387098 EXCIMER, LASER SYSTEM EXCIMER, LASER SYSTEM LZS UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Disability