BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONARCH IOL DELIVERY SYSTEM - CARTRIDGE

    MDR report key: 317004 · Received February 15, 2001

    Report

    Report Number
    1119421-2001-00171
    Event Type
    Malfunction
    Date Received
    February 15, 2001
    Report Date
    January 16, 2001
    Manufacturer
    ALCON LABORATORIES, INC. / HUNTINGTON
    Product Code
    KYB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    A USER FACILITY REPORTED THAT AN INTRAOCULAR LENS (IOL) BECAME STUCK IN THE CARTRIDGE OF AN IOL DELIVERY SYSTEM. THERE WAS NO PT IMPACT/INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    5974 MONARCH IOL DELIVERY SYSTEM - CARTRIDGE LENS GUIDE KYB ALCON LABORATORIES, INC. / HUNTINGTON NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN