BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CALLISTO EYE

    MDR report key: 7023374 · Received November 10, 2017

    Report

    Report Number
    9615010-2017-00012
    Event Type
    Injury
    Date Received
    November 10, 2017
    Date of Event
    October 10, 2017
    Report Date
    October 13, 2017
    Manufacturer
    CARL ZEISS MEDITEC AG (OBERKOCHEN)
    Product Code
    NFJ
    UDI-DI
    04049539103512
    PMA / PMN Number
    K123464
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BEFORE STARTING A SURGERY WITH CALLISTO EYE, THE POSITION OF THE HEALTH CARE PROFESSIONAL (HCP) MUST BE SET IN RELATION TO THE PATIENT'S HEAD (RIGHT, LEFT, OR TOP). THE SELECTED POSITION IS INDICATED ON THE LIVE VIDEO SCREEN THROUGHOUT THE SURGERY. IN THIS PARTICULAR CASE, THE "RIGHT" POSITION WAS SELECTED IN CALLISTO EYE, BUT THE HCP WAS PHYSICALLY POSITIONED NEAR THE TOP OF THE PATIENT'S HEAD. THIS CAUSED THE 90 DEGREE DISCREPANCY IN THE DISPLAYED TARGET AXIS.

    Description of Event or Problem · 1

    THE HEALTH CARE PROFESSIONAL (HCP) REPORTED THAT A TORIC IOL WAS IMPLANTED IN THE PATIENT'S RIGHT EYE 90 DEGREES OFF THE DESIRED AXIS. THE MARKERLESS FUNCTION OF THE CALLISTO EYE HAD BEEN USED TO POSITION THE IOL. THE PATIENT'S ASTIGMATIC OUTCOME WAS ABOUT 6.0 DIOPTERS, WHICH RESULTED IN POOR VISUAL ACUITY. THE HCP DECIDED TO PERFORM A FOLLOW-UP SURGERY USING THE CALLISTO EYE TO RE-POSITION THE IOL. AFTER THE CORRECTIVE TREATMENT, THE PATIENT'S ASTIGMATISM IS ABOUT 0.25 DIOPTERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    796008 CALLISTO EYE CALLISTO EYE NFJ CARL ZEISS MEDITEC AG (OBERKOCHEN) NA NA 04049539103512

    Patients

    Seq Age Sex Outcome Treatment
    1 Other