BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CALLISTO EYE

    MDR report key: 14115842 · Received April 14, 2022

    Report

    Report Number
    9615010-2022-00003
    Event Type
    Malfunction
    Date Received
    April 14, 2022
    Date of Event
    March 17, 2022
    Report Date
    April 14, 2022
    Manufacturer
    CARL ZEISS MEDITEC AG
    Product Code
    NFJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THERE WAS A MALFUNCTION OF THE DEVICE, THE SURGEON REALIZED THIS. THE INFORMATION FOR USER DESCRIBES THAT THE DEVICE MAY NOT BE USED IN THIS SITUATION. NEVERTHELESS, THE SURGEON PROCEEDED TO USE THE DEVICE.

    Description of Event or Problem · 0

    A HEALTHCARE PROFESSIONAL (HCP) REPORTED "DURING CATARACT SURGERY (1ST INTERVENTION), THE SURGEON'S FCP FUNCTION WAS NOT ACCORDING TO HIS USUAL SETTING: HE LOST THE FUNCTION XY. DURING THE SECOND INTERVENTION, AFTER A RESTART OF THE ARTEVO, HE LOST THE ZOOM AND FOCUS FUNCTION. THERE WAS A CASPULAR BAG RUPTURE DURING THIS SURGERY. THE SURGEON THINKS THAT THIS CONSEQUENCE IS LINKED TO THE DIFFERENT DEPROGRAMMINGS. THE SURGERY HAS BEEN COMPLETED BY THE USE OF ANOTHER MICROSCOPE AND AN IOL WAS IMPLANTED ON THE SULCUS BAG."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1089065 CALLISTO EYE CALLISTO EYE NFJ CARL ZEISS MEDITEC AG

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention