BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CALLISTO EYE

    MDR report key: 22323726 · Received June 24, 2025

    Report

    Report Number
    3009746052-2025-00001
    Event Type
    Injury
    Date Received
    June 24, 2025
    Date of Event
    May 26, 2025
    Report Date
    June 24, 2025
    Manufacturer
    CARL ZEISS MEDITEC AG (MUNICH)
    Product Code
    OBO
    PMA / PMN Number
    K180229
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    RELATED REPORTS: OPMI LUMERA 700: 9615010-2025-00014. RESCAN 700: 9615010-2025-00015.

    Description of Event or Problem · 0

    A HEALTH CARE PROFESSIONAL (HCP) REPORTED THAT AN ISSUE OCCURRED DURING A GLAUCOMA AND CATARACT SURGERY, INVOLVING THE OPMI LUMERA 700, RESCAN 700, AND CALLISTO EYE. ACCORDING TO THE REPORT, THE SURGERY BEGAN WITH THE MICROSCOPE PROVIDING CORRECT VISUALIZATION AND BRIGHTNESS. THE CAPSULORHEXIS WAS PERFORMED WITHOUT ISSUE. DURING THE PHACOEMULSIFICATION, THE LIGHT POWER AND BRIGHTNESS FROM THE MICROSCOPE WERE LOST. DUE TO POOR VISUALIZATION, A POSTERIOR CAPSULAR RUPTURE OCCURRED, AND FRAGMENTS OF THE EPINUCLEUS AND CORTEX WERE DISLOCATED INTO THE VITREOUS CAVITY. AN ANTERIOR VITRECTOMY WAS PERFORMED, AND A LENS WAS IMPLANTED IN THE CILIARY SULCUS, BUT WITH VERY POOR VISIBILITY TO COMPLETE THE SURGERY. THE LABORATORY PERSONNEL REPRESENTING THE MICROSCOPE EXPLAINED THAT THE STARTUP PROTOCOL HAD BEEN FOLLOWED CORRECTLY. THE PATIENT HAS HAD TO UNDERGO RE-OPERATION TWICE, AND HAS HAD VERY HIGH IOPS (EYE PRESSURE). THE DOCTOR IS WAITING TO SEE IF THE PATIENT ULTIMATELY LOSES TOO MUCH VISION IN THE PATIENT'S ONE AFFECTED EYE FOR ANY FURTHER INTERVENTION. THE ROOT CAUSE CANNOT BE DETERMINED YET DUE TO LACK OF FURTHER INFORMATION. FURTHER INVESTIGATION IS REQUIRED AND IS IN PROGRESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1457639 CALLISTO EYE CALLISTO EYE OBO CARL ZEISS MEDITEC AG (MUNICH)

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| O