BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EX-PRESS MIN GLAUCOMA SHUNT

    MDR report key: 4137733 · Received September 28, 2014

    Report

    Report Number
    3003701944-2014-00172
    Event Type
    Malfunction
    Date Received
    September 28, 2014
    Date of Event
    October 2, 2013
    Report Date
    September 1, 2014
    Manufacturer
    OPTONOL, LTD
    Product Code
    KYF
    PMA / PMN Number
    K030350
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS, THEREFORE, THE CONDITION OF THE PRODUCT COULD NOT BE VERIFIED AND VISUAL INSPECTION CANNOT BE PERFORMED; THE GFD REMAINS IMPLANTED. THE DEVICE HISTORY RECORD (DHR) FOR THE BATCH WAS REVIEWED. THE PRODUCT WAS RELEASED ACCORDING TO RELEASE CRITERIA. THE ROOT CAUSE CANNOT BE DETERMINED. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ADDITIONAL INFORMATION HAS BEEN REQUESTED. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT SIX MONTHS FOLLOWING A GLAUCOMA FILTRATION DEVICE (GFD) IMPLANT PROCEDURE, THE GFD WAS OBSERVED TO BE TOUCHING THE IRIS. THE GFD REMAINS IMPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS REPORT. THIS FILE IS FOR THE LEFT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    604317 EX-PRESS MIN GLAUCOMA SHUNT AQUEOUS SHUNT KYF OPTONOL, LTD P-50 PL 122816

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR