BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE C

    MDR report key: 17892593 · Received October 7, 2023

    Report

    Report Number
    1119421-2023-01719
    Event Type
    Malfunction
    Date Received
    October 7, 2023
    Date of Event
    September 14, 2023
    Report Date
    October 7, 2023
    Manufacturer
    ALCON RESEARCH, LLC - HUNTINGTON
    Product Code
    MSS
    UDI-DI
    00380659777622
    PMA / PMN Number
    K112977
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A SAMPLE DEVICE WAS NOT RETURNED FOR ANALYSIS. COMPLAINT HISTORY AND PRODUCT HISTORY RECORDS WERE REVIEWED AND DOCUMENTATION INDICATED THE PRODUCT MET RELEASE CRITERIA. ROOT CAUSE HAS NOT BEEN IDENTIFIED. THE FIRST PHOTO SHOWED THE LENS CARTON ENDCAP WITH THE SERIAL NUMBER. THE LENS WAS IN FROM OF THE CARTON, POSTERIOR SURFACE UP. VISCOELASTIC AND POSSIBLE BLOOD WAS OBSERVED DRIED ON THE LENS. THE HAPTICS WERE INTACT. NO TORN "CHEWED" AREAS WERE OBSERVED. THE SECOND PHOTO WAS THE BOTTOM VIEW OF A COMPANY CARTRIDGE. THE VIEW WAS FROM THE LOADING AREA TO MID-NOZZLE. THE TIP WAS NOT VISIBLE. UNABLE TO OBSERVE/DETERMINE VISCOELASTIC AMOUNT. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 0

    A STOKIST REPORTED THAT DURING SURGERY THE CARTRIDGE CHEWED UP THE LENS. ADDITIONAL INFORMATION WAS REQUESTED, RECEIVED AND STATED THERE WAS NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2095085 MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE C FOLDERS AND INJECTORS, INTRAOCULAR LENS (IOL) MSS ALCON RESEARCH, LLC - HUNTINGTON NA 15617184 00380659777622

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Female ACRYSOF IQ NATURAL SINGLEPIECE IOL.