BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LASIK

    MDR report key: 8936107 · Received August 27, 2019

    Report

    Report Number
    MW5089352
    Event Type
    Injury
    Date Received
    August 27, 2019
    Date of Event
    January 23, 2019
    Report Date
    August 24, 2019
    Manufacturer
    UNK
    Product Code
    LZS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAD LASIK AT (B)(6) BY (B)(6). I TOLD THE DR I HAD BAD ALLERGIES AND TOOK ALLERGY MEDS DAILY. I ALSO TOLD HIM I WAS NURSING MY CHILD AND IT WAS VERY IMPORTANT TO ME. I ALSO TOLD HIM I HAD AUTOIMMUNE DISORDERS THAT WASN'T A PROBLEM EITHER. SINCE MY LIFE ENDED, I NO LONGER CAN NURSE MY CHILD, TAKE ALLERGY MEDS, TAKEN BY KIND OF MEDICATION. I CAN'T GO MORE THAN 30 MINS WITHOUT PUTTING DROPS IN MY EYES. BOTH MY UNDER EYES HAVE BEEN SWOLLEN OR PUFFY SINCE THE SURGERY, SO I WALK AROUND IN SUNGLASSES ALL DAY AND ALL NIGHT. IT'S A NIGHTMARE AND I JUST WANT TO DIE. I FEAR FOR MY CHILDREN TO GROW UP WITHOUT THEIR MOTHER BUT I DON'T KNOW HOW MUCH MORE PAIN I CAN TAKE. LASIK ENDED MY LIFE, IT'S ONLY A MATTER OF TIME BEFORE I END MY LIFE AND BECOME PAIN FREE. PLEASE PRAY FOR ME. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    728948 LASIK EXCIMER LASER SYSTEM LZS UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Life Threatening| R| S A TONS OF EYE VITAMINS| FISH OIL| LDN | NP THYROID | OMEGA 7