BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNFOLDER PLATINUM SERIES CARTRIDGE

    MDR report key: 5177100 · Received October 26, 2015

    Report

    Report Number
    5177100
    Event Type
    Malfunction
    Date Received
    October 26, 2015
    Date of Event
    September 22, 2015
    Report Date
    October 21, 2015
    Manufacturer
    ABBOTT MEDICAL OPTICS INC. (AMO)
    Product Code
    KYB
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING CATARACT SURGERY, WHEN THE DOCTOR WAS IMPLANTING THE INTRAOCULAR LENS, HE NOTICED THE TIP OF THE CARTRIDGE BROKE. STAFF OPENED A NEW CARTRIDGE AND PROCEEDED WITH THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    707764 UNFOLDER PLATINUM SERIES CARTRIDGE LENS, GUIDE, INTRAOCULAR KYB ABBOTT MEDICAL OPTICS INC. (AMO) CPO2924

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR NO