BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISUMAX

    MDR report key: 10962499 · Received December 7, 2020

    Report

    Report Number
    9615030-2020-00019
    Event Type
    Malfunction
    Date Received
    December 7, 2020
    Date of Event
    November 7, 2020
    Report Date
    November 7, 2020
    Manufacturer
    CARL ZEISS MEDITEC AG (JENA)
    Product Code
    OTL
    PMA / PMN Number
    P150040
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A HEALTHCARE PROFESSIONAL REPORTED THAT THE VISUMAX HAD AN INCORRECT LASER PATTERN. THE VISUMAX WAS USED ON TWO PATIENTS. IMPACT ON THE PATIENTS DUE TO USE OF THE VISUMAX IS NOT KNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1427315 VISUMAX FEMTOSECOND LASER SYSTEM FOR REFRACTIVE CORRECTION OTL CARL ZEISS MEDITEC AG (JENA) N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1