BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MONARCH III IOL DELIVERY SYSTEM HANDPIECE

    MDR report key: 3221806 · Received July 9, 2013

    Report

    Report Number
    2523835-2013-00098
    Event Type
    Injury
    Date Received
    July 9, 2013
    Date of Event
    June 3, 2013
    Report Date
    June 3, 2013
    Manufacturer
    ALCON PRECISION DEVICE - SINKING SPRING
    Product Code
    KYB
    PMA / PMN Number
    K063155
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO HANDPIECE INJECTOR WAS RECEIVED FOR A SCRATCHED OPTIC. NO LOT NUMBER WAS IDENTIFIED WITH THIS COMPLAINT; THEREFORE, A LOT HISTORY REVIEW COULD NOT BE CONDUCTED. BECAUSE THE HANDPIECE INJECTOR SAMPLE WAS NOT RETURNED AND NO INJECTOR LOT INFORMATION WAS PROVIDED, THE ROOT CAUSE IS UNKNOWN, NO MALFUNCTIONS WERE CONFIRMED. ADDITIONAL INFORMATION HAS BEEN REQUESTED. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, A SCRATCH WAS NOTICED ON THE LENS. THE LENS WAS REMOVED AND REPLACED WITH ANOTHER LENS, SAME MODEL AND POWER. ADDITIONAL INFORMATION WAS RECEIVED FROM THE SURGEON INDICATING THE EVENT WAS CAUSED BY THE INJECTOR. THE IOL WAS INSERTED AND A SERIES OF SMALL SCRATCHES ON THE LENS CENTRALLY WAS NOTICED. THE SURGEON ELECTED TO REMOVE THE LENS AND INSERT ANOTHER IOL OF THE SAME POWER WITH A NEW CARTRIDGE, MORE SCRATCHED WERE FOUND CENTRALLY ON THIS LENS SURFACE THAN ON THE PREVIOUS LENS. THE WOUND WAS SLIGHTLY ENLARGED TO REMOVE THIS LENS WELL. THE SURGEON REPORTED AN IRIS PROLAPSE, BUT HE WAS ABLE TO REPOSITION THE IRIS. THE EYE WAS LEFT APHAKIC AND THE WOUND WAS SUTURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312432 MONARCH III IOL DELIVERY SYSTEM HANDPIECE LENS GUIDE KYB ALCON PRECISION DEVICE - SINKING SPRING NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention