BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALCON ACCURUS 25+ GAUGE VITRECTOMY TOTAL PLUS PAK

    MDR report key: 2931780 · Received January 22, 2013

    Report

    Report Number
    2931780
    Event Type
    Malfunction
    Date Received
    January 22, 2013
    Date of Event
    March 28, 2012
    Report Date
    January 22, 2013
    Manufacturer
    ALCON
    Product Code
    KYG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US

    Narratives

    Description of Event or Problem · 1

    LIGHT CORD COMING APART FROM THE TIP IN THE PACK, ALSO DIFFICULT PEELING PROTECTOR OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29148 ALCON ACCURUS 25+ GAUGE VITRECTOMY TOTAL PLUS PAK VITRECTOMY, INSTRUMENT CUTTER, LIGHT CORD KYG ALCON * 12010543X-2012-1

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR