BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LASIK

    MDR report key: 19392828 · Received May 23, 2024

    Report

    Report Number
    MW5155365
    Event Type
    Injury
    Date Received
    May 23, 2024
    Date of Event
    August 12, 2004
    Report Date
    May 22, 2024
    Manufacturer
    UNKNOWN
    Product Code
    LZS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I HAD LASIK SURGERY FOR BOTH MY EYES IN (B)(6), NEW ZEALAND. IMMEDIATELY AFTER SURGERY I HAD EXTREME DISCOMFORT IN MY RIGHT EYE. MY LEFT WAS TENDER AND WHAT YOU WOULD EXPECT POST SURGERY. MY EYES BOTH NOW HAVE HOAS (HIGHER-ORDER ABERRATIONS). I AM UNABLE TO DRIVE AT NIGHT AND AM LIMITED TO CERTAIN AREAS OF BRIGHT LIGHTS. BUT THE REAL PROBLEM IS THE CONSTANT PAIN. I HAVE BEEN TOLD I HAVE DRY EYE WHICH SEEMS TO BE CONSTANT WHATEVER EYE DROPS OR OTHER PROCEDURES SUGGESTED TO RELIEVE SYMPTOMS. I ALSO SUFFER FROM CORNEAL EROSION. I AM LIMITED TO SCREEN TIME, CAN'T GO OUTSIDE WITHOUT SUNGLASSES, CAN'T GO OUTSIDE IN WINDY CONDITIONS, THE LIST GOES ON. I WAS NEVER INFORMED OF THE RISKS IN MY PRELIMINARY SURGERY APPOINTMENT. THE FIRST I WAS TOLD ABOUT ANY POSSIBLE ADVERSE EFFECTS WAS SIGNING A FORM 5 MINUTES BEFORE SURGERY AND AFTER BEING GIVEN A RELAXATION DRUG. I HAVE KEPT THIS BRIEF BUT HAPPY TO DISCUSS FURTHER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1940016 LASIK EXCIMER LASER SYSTEM LZS UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Female Disability