BEUDAMED
    FDA Adverse Event Other Summary report: N

    DUCKWORTH AND KENT

    MDR report key: 2850681 · Received October 10, 2012

    Report

    Report Number
    8021817-2012-00001
    Event Type
    Other
    Date Received
    October 10, 2012
    Date of Event
    September 25, 2012
    Report Date
    October 10, 2012
    Manufacturer
    DUCKWORTH & KENT, LTD.
    Product Code
    MSS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IOL INJECTOR DELIVERED AN IOL INTO THE PT'S EYE IN AN AGGRESSIVE WAY CAUSING A CAPSULE RUPTURE. THIS IS AN IOL INJECTOR THAT IS USED TO DELIVER AN IOL INTO THE EYE. THE SURGEON HAS REPORTED THAT THE DEVICE DELIVERED THE LENS AGGRESSIVELY AND THAT AS A RESULT, THE PT SUFFERED A CAPSULE RUPTURE INCREASED IOP, RED EYE AND PAIN. THE INJECTOR WAS RETURNED TO D&K FOR EVALUATION. NO FAULT RELATING TO THE INCIDENT COULD BE FOUND. THE MOST PROBABLE CAUSE OF THE EVENT WAS A MISS-LOADING OF THE CARTRIDGE INTO THE CARTRIDGE CHAMBER. THE CARTRIDGE IS NOT A D&K PRODUCT AND WAS NOT RETURNED WITH THE INJECTOR FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DUCKWORTH AND KENT IOL INJECTOR MSS DUCKWORTH & KENT, LTD. DK7797-2 013

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization