BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONARCH III IOL DELIVERY SYSTEM, INJECTOR

    MDR report key: 22084927 · Received May 26, 2025

    Report

    Report Number
    2523835-2025-00621
    Event Type
    Malfunction
    Date Received
    May 26, 2025
    Date of Event
    April 29, 2025
    Report Date
    October 4, 2025
    Manufacturer
    ALCON RESEARCH, LLC - ALCON PRECISION DEVICE
    Product Code
    KYB
    PMA / PMN Number
    K063155
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4). H.10 REFLECTS ALL RELATED REPORT NUMBERS ASSOCIATED WITH THIS PRODUCT EVENT THAT HAVE BEEN SUBMITTED AT THIS TIME.

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4). H.10 REFLECTS ALL RELATED REPORT NUMBERS ASSOCIATED WITH THIS PRODUCT EVENT THAT HAVE BEEN SUBMITTED AT THIS TIME.

    Additional Manufacturer Narrative · 0

    CORRECTED INFORMATION PROVIDED IN H.6. AND H.11. ON INITIAL MDR THE FDA COMPONENT CODE OF GO5006 WAS AN ERROR. IT SHOULD HAVE BEEN G04044 ON THE ORIGINAL MDR. ADDITIONAL INFORMATION PROVIDED IN H.3., H.6. AND H.11 A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IT WAS FOUND THAT HAPTIC AND LENS OPTIC FOUND TO BE BROKEN WHEN THE IOL WAS BEING INSERTED. THERE WAS PATIENT CONTACT NOTED. COMPANY INJECTOR HAD ALSO BEEN USED. ADDITIONAL INFORMATION HAS BEEN REQUESTED HOWEVER NO FURTHER INFORMATION PROVIDED. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4). H.10 REFLECTS ALL RELATED REPORT NUMBERS ASSOCIATED WITH THIS PRODUCT EVENT THAT HAVE BEEN SUBMITTED AT THIS TIME.

    Description of Event or Problem · 0

    A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IT WAS FOUND THAT HAPTIC BROKEN/TORN/MISSING AND LENS OPTIC BROKEN/CRACKED/SPLIT/TORN. WHEN THE IOL WAS BEING INSERTED, THERE WAS PATIENT CONTACT NOTED. COMPANY INJECTOR HAD ALSO BEEN USED. ADDITIONAL INFORMATION HAS BEEN REQUESTED HOWEVER NO FURTHER INFORMATION PROVIDED.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED AND STATED THAT LENS FOUND FOLDED ONCE INSERTED, THEN TORE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331983 MONARCH III IOL DELIVERY SYSTEM, INJECTOR LENS, GUIDE, INTRAOCULAR KYB ALCON RESEARCH, LLC - ALCON PRECISION DEVICE III ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male CLAREON ASPHERIC HYDROPHOBIC ACRYLIC IOL.