BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MONARCH IOL DELIVERY SYSTEM - CARTRIDGE

    MDR report key: 386440 · Received April 5, 2002

    Report

    Report Number
    1119421-2002-00123
    Event Type
    Injury
    Date Received
    April 5, 2002
    Report Date
    March 7, 2002
    Manufacturer
    ALCON LABORATORIES, INC./HUNTINGTON
    Product Code
    LYB
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    A NURSE AT THE USER FACILITY REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANTATION, THE LENS DID NOT FOLD/INJECT PROPERLY. DURING THIS PROCEDURE, AN ANTERIOR VITRECTOMY WAS DONE. THE LENS WAS INSERTED USING THE IOL DELIVERY SYSTEM. ADD'L INFO HAS BEEN REQUESTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Required Intervention