BEUDAMED
    FDA Adverse Event Other Summary report: N

    D&K IMPLANTATION SYSTEM

    MDR report key: 2305998 · Received October 20, 2011

    Report

    Report Number
    8021817-2011-00001
    Event Type
    Other
    Date Received
    October 20, 2011
    Date of Event
    January 1, 2011
    Report Date
    October 19, 2011
    Manufacturer
    DUCKWORTH & KENT, LTD.
    Product Code
    MSS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    EVENT REPORTED BY CLINIC IN (B)(6). PROBLEM OCCURRED WITH DELIVERY OF IOL. NOTES RECEIVED FROM (B)(4) DISTRIBUTOR AS FOLLOWS: DR COMPLAINED THAT ULTRA INJECTOR AS UNSAFE TO USE. ULTRA INJECTOR WAS USED TO IMPLANT TECNIS ONE MULTIFOCAL INTRAOCULAR LENS IN PT. THERE WAS NO OBVIOUS OTHER THAN NORMAL RESISTANCE. IOL WAS SHOT THROUGH THE POSTERIOR CAPSULAR BAG, POSTERIOR CAPSULAR BAG WAS TORN. LEAKAGE OF VITREOUS FLUID. A THREE PIECE MF IOL WAS INSTEAD PLACED INTO THE SULCUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 D&K IMPLANTATION SYSTEM IOL INJECTOR MSS DUCKWORTH & KENT, LTD. DK7786

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention