BEUDAMED
    FDA Adverse Event Summary report: N

    MONARCH III IOL

    MDR report key: 2873475 · Received November 30, 2012

    Report

    Report Number
    2873475
    Date Received
    November 30, 2012
    Date of Event
    October 24, 2012
    Report Date
    November 30, 2012
    Manufacturer
    ALCON
    Product Code
    KYB
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    WHEN SURGEON INSERTED THE IMPLANT LENS ON A CATARACT PATIENT, SURGEON NOTICED A RESIDUAL ON LENS. SURGEON UNSURE IF THE RESIDUAL COMES FROM THE CARTRIDGE OR THE INSERTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MONARCH III IOL LENS, GUIDE, INTRAOCULAR KYB ALCON * 032170752

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR NO OTHER THERAPIES