BEUDAMED
    FDA Adverse Event Other Summary report: N

    LASIK

    MDR report key: 3983418 · Received August 1, 2014

    Report

    Report Number
    MW5037609
    Event Type
    Other
    Date Received
    August 1, 2014
    Date of Event
    February 20, 2014
    Report Date
    August 1, 2014
    Product Code
    LZS
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    CALLER REPORTS HE HAD LASIK SURGERY PERFORMED IN HIS RIGHT EYE IN (B)(6) OF 2014. TWO DAYS AFTER THE PROCEDURE HE REPORTS THAT HIS VISION STARTED TO BECOME DISTORTED AND DARKER. CALLER STATES HE WENT TO THE DOCTOR AND FOUND THAT HIS RETINA WAS DETACHED AND AN EMERGENCY SURGERY WAS PERFORMED ON (B)(6) 2014. CALLER REPORTS THAT HE IS STILL EXPERIENCING VISION ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    451564 LASIK LASIK LZS

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR