BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLAREON MONARCH IV IOL DELIVERY SYSTEM, INJECTOR

    MDR report key: 24679247 · Received March 24, 2026

    Report

    Report Number
    2523835-2026-00314
    Event Type
    Malfunction
    Date Received
    March 24, 2026
    Date of Event
    February 25, 2026
    Report Date
    March 24, 2026
    Manufacturer
    ALCON RESEARCH, LLC - ALCON PRECISION DEVICE
    Product Code
    MSS
    PMA / PMN Number
    K212039
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    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.

    Description of Event or Problem · 0

    A HEALTHCARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, DIFFICULTY IN THE OUTPUT OF THE INJECTOR, SO SURGEON DECIDED NOT TO IMPLANT IT IN THE PATIENT AND NOTICED ONCE THE LENS COMES OUT THAT HAPTIC WAS FRACTURED. REPORTER CONSIDERED THAT THE ADVERSE EVENTS PRESENTED MAY BE RELATED TO THE INJECTOR. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THERE WAS NO PATIENT CONTACT. THE PROCEDURE WAS COMPLETED ON SAME DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183640 CLAREON MONARCH IV IOL DELIVERY SYSTEM, INJECTOR FOLDERS AND INJECTORS , INRAOCULAR LENS (IOL) MSS ALCON RESEARCH, LLC - ALCON PRECISION DEVICE IV ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1