BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPMI LUMERA 700

    MDR report key: 18361038 · Received December 19, 2023

    Report

    Report Number
    9615010-2023-00015
    Event Type
    Injury
    Date Received
    December 19, 2023
    Date of Event
    November 15, 2023
    Report Date
    December 19, 2023
    Manufacturer
    CARL ZEISS MEDITEC AG (OBERKOCHEN)
    Product Code
    HRM
    UDI-DI
    04049539066343
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    FURTHER ANALYSIS BY THE MANUFACTURER REVEALED THAT IF THE DOUBLE IRIS DIAPHRAGM FAILS, THE ENTIRE PERFORMANCE OF THE DEPTH OF FIELD SHOULD NOT BE LOST. THE DISPLAYED IMAGE CAN ONLY BECOME EXTREMELY DARK WITH INSUFFICIENT LIGHTING OR UNFAVORABLE PHYSIOLOGY OF THE EYE. THIS CAN BE CORRECTED BY ADJUSTING THE ILLUMINANCE, SELECTING A LOWER MAGNIFICATION OR REFOCUSING. THEREFORE, THE CAPSULE RUPTURES DESCRIBED MUST NECESSARILY BE LINKED TO THE MALFUNCTION OF THE DOUBLE IRIS DIAPHRAGM. THE CAPSULE RUPTURE CAN ALSO BE DUE TO PATHOLOGICAL REASONS OR HANDLING ERRORS. INFORMATION ON THE CASE SUGGEST A USER ERROR BECAUSE: AN INSTRUMENT WAS USED DESPITE RESTRICTED VISION. REPORTED CONDITIONS SUCH AS BLUR COULD HAVE BEEN CORRECTED BY ADJUSTING THE ILLUMINATION, CHOOSING A LOWER MAGNIFICATION OR REFOCUSING. THE IFU CLEARLY STATES NOT TO USE THE INSTRUMENT IN CASE ERRORS OCCUR THAT CANNOT BE FIXED.

    Description of Event or Problem · 0

    A CUSTOMER REPORTED CAPSULE RUPTURE OF A PATIENT DURING CATARACT SURGERY DUE TO DARK AND BLURRED VIEW WITH A LACK OF DEPTH OF FIELD THROUGH THE EYEPIECES. AS A RESULT OF THE EVENT, A SULCUS FIXED HKL HAD TO BE INSERTED DUE TO THE ANTERIOR CAPSULE DEFECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2110310 OPMI LUMERA 700 MICROSCOPE, SURGICAL, GENERAL & PLASTIC SURGERY HRM CARL ZEISS MEDITEC AG (OBERKOCHEN) N/A N/A 04049539066343

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention