BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTISAN

    MDR report key: 5570119 · Received April 7, 2016

    Report

    Report Number
    MW5061612
    Event Type
    Injury
    Date Received
    April 7, 2016
    Date of Event
    March 31, 2016
    Report Date
    April 7, 2016
    Manufacturer
    OPHTEC BV
    Product Code
    MTA
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    CYSTOID MACULAR EDEMA WAS NOTED THROUGH OPTICAL COHERENCE TOMOGRAPHY EXAM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212475 ARTISAN PHAKIC LENS MTA OPHTEC BV 205 104656

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other