BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPMI LUMERA T

    MDR report key: 8725076 · Received June 21, 2019

    Report

    Report Number
    9615010-2019-00004
    Event Type
    Malfunction
    Date Received
    June 21, 2019
    Report Date
    May 24, 2019
    Manufacturer
    CARL ZEISS MEDITEC AG (OBERKOCHEN)
    Product Code
    HRM
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    A DISTRIBUTOR SALES REPRESENTATIVE FOR CARL ZEISS MEDITEC INC. DISCOVERED THAT THE OPMI LUMERA T HAD A LIGHT MODULE INSTALLED WHICH IS NOT INTENDED FOR OPHTHALMIC SURGERIES. THERE HAS NOT BEEN ANY REPORT OF AN INJURY DUE TO THE INCORRECT LIGHT SOURCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    518573 OPMI LUMERA T OPMI LUMERA T HRM CARL ZEISS MEDITEC AG (OBERKOCHEN) N/A NA

    Patients

    Seq Age Sex Outcome Treatment
    1