BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EX-PRESS MINI GLAUCOMA SHUNT

    MDR report key: 4102184 · Received September 17, 2014

    Report

    Report Number
    3003701944-2014-00163
    Event Type
    Malfunction
    Date Received
    September 17, 2014
    Date of Event
    March 19, 2013
    Report Date
    August 21, 2014
    Manufacturer
    OPTONOL, LTD
    Product Code
    KYF
    PMA / PMN Number
    K030350
    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; THE GLAUCOMA FILTRATION DEVICE REMAINS IMPLANTED. THE CONDITION OF THE PRODUCT COULD NOT BE VERIFIED AND VISUAL INSPECTION CANNOT BE PERFORMED. THE DEVICE HISTORY RECORD (DHR) FOR THE BATCH WAS REVIEWED. NO ABNORMALITIES WERE FOUND DURING THE DHR REVIEW AND THE PRODUCT WAS RELEASED ACCORDING TO RELEASE CRITERIA. THE PRODUCT INVESTIGATION COULD NOT IDENTIFY A ROOT CAUSE. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ADDITIONAL INFORMATION HAS BEEN REQUESTED. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THREE MONTHS FOLLOWING A GLAUCOMA FILTRATION DEVICE (GFD) IMPLANT PROCEDURE, THE GFD WAS OBSERVED TO BE TOUCHING THE IRIS. THE GFD REMAINS IMPLANTED WITH NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    576447 EX-PRESS MINI GLAUCOMA SHUNT AQUEOUS SHUNT KYF OPTONOL, LTD P-50 PL 122513

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR