BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EX-PRESS MINI GLAUCOMA SHUNT

    MDR report key: 4223860 · Received August 5, 2014

    Report

    Report Number
    3003701944-2014-00127
    Event Type
    Malfunction
    Date Received
    August 5, 2014
    Date of Event
    January 18, 2013
    Report Date
    July 14, 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

    EVAL SUMMARY: NO SAMPLE WAS RETURNED, THEREFORE, THE CONDITION OF THE PRODUCT COULD NOT BE VERIFIED AND VISUAL INSPECTION CANNOT BE PERFORMED. BECAUSE A SAMPLE WAS NOT RETURNED, THE ROOT CAUSE CANNOT BE DETERMINED AND NO ACTIONS ARE TAKEN. ADD'L INFO HAS BEEN REQUESTED. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED FOLLOWING A GLAUCOMA FILTRATION DEVICE IMPLANTATION, THE SHUNT IS TOUCHING THE IRIS. THERE IS NO HARM TO THE PT AND THE SHUNT REMAINS IN THE EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    456361 EX-PRESS MINI GLAUCOMA SHUNT AQUEOUS SHUNT KYF OPTONOL, LTD P-50 PL UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR