BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPMI LUMERA

    MDR report key: 9158714 · Received October 4, 2019

    Report

    Report Number
    9615010-2019-00013
    Event Type
    Injury
    Date Received
    October 4, 2019
    Date of Event
    August 30, 2019
    Report Date
    September 5, 2019
    Manufacturer
    CARL ZEISS MEDITEC AG (OBERKOCHEN)
    Product Code
    HRM
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    CARL ZEISS MEDITEC INC. MADE MULTIPLE ATTEMPTS TO OBTAIN INFORMATION REGARDING THE PATIENT OUTCOME AND IT IS UNKNOWN AT THIS TIME.

    Description of Event or Problem · 1

    THE HEALTH CARE PROFESSIONAL (HCP) REPORTED THAT, WHILE PERFORMING CATARACT SURGERY, THE DEVICE'S LIGHT SHUT OFF IN THE MIDDLE OF THE CASE. THE SURGEON COULD NOT SEE, CAUSING A COMPLICATION (RUPTURE), AND THE SURGEON HAD TO PERFORM AN UNPLANNED VITRECTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    949134 OPMI LUMERA OPMI LUMERA HRM CARL ZEISS MEDITEC AG (OBERKOCHEN) N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention