BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LASIK SURGERY / EXCIMER LASER SYSTEM

    MDR report key: 7582285 · Received June 7, 2018

    Report

    Report Number
    MW5077706
    Event Type
    Injury
    Date Received
    June 7, 2018
    Date of Event
    April 24, 2018
    Report Date
    June 5, 2018
    Manufacturer
    UNK
    Product Code
    LZS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I AM A LASIK PT - BILATERAL LASIK PERFORMED (B)(6) 2014 AT (B)(6)\. ON (B)(6) 2018, I WAS DIAGNOSED WITH A RETINAL DETACHMENT AND RUSHED TO EMERGENCY SURGERY FOR A SCLERAL BUCKLE PLACEMENT IN MY LEFT EYE. ON (B)(6) 2018, I WAS DIAGNOSED WITH RETINAL "LATTICE" IN MY RIGHT EYE, WHICH MY SURGEON DESCRIBED AS A "THINNING" OF THE RETINA. THIS IS A PRECURSOR TO DETACHMENT AS THE THINNING ALLOWS HOLES TO FORM AND FLUID TO GET BEHIND THE RETINA, EVENTUALLY CAUSING IT TO DETACH. THERE IS NO PREVIOUS HISTORY OF RETINAL DETACHMENT IN MY FAMILY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    423279 LASIK SURGERY / EXCIMER LASER SYSTEM LASIK SURGERY / EXCIMER LASER SYSTEM LZS UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Hospitalization| O