BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNFOLDER PLATINUM 1 SERIES IMPLANTATION SYSTEM

    MDR report key: 5145041 · Received October 13, 2015

    Report

    Report Number
    5145041
    Event Type
    Malfunction
    Date Received
    October 13, 2015
    Date of Event
    September 23, 2015
    Report Date
    October 6, 2015
    Manufacturer
    ABBOTT MEDICAL OPTICS INC. (AMO)
    Product Code
    HQL
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING CATERACT SURGERY WHILE MD WAS IMPLANTING THE INTRAOCULAR LENS, HE NOTICED THE TIP OF THE CARTIDGE BROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    676830 UNFOLDER PLATINUM 1 SERIES IMPLANTATION SYSTEM LENS, GUIDE, INTRAOCULAR HQL ABBOTT MEDICAL OPTICS INC. (AMO) CPO2924

    Patients

    Seq Age Sex Outcome Treatment
    1 NO