BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EX-PRESS MINI GLAUCOMA SHUNT

    MDR report key: 4289480 · Received November 13, 2014

    Report

    Report Number
    3003701944-2014-00224
    Event Type
    Malfunction
    Date Received
    November 13, 2014
    Date of Event
    March 4, 2013
    Report Date
    October 20, 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: THE PRODUCT DID NOT RETURN FOR ANALYSIS; THE GFD REMAINS IMPLANTED. THE CONDITION OF THE PRODUCT COULD NOT BE VERIFIED AND VISUAL INSPECTION CANNOT BE PERFORMED. NO DATA REGARDING PRODUCT IDENTITY WAS RECEIVED IE NO LOT OR SERIAL NUMBER WERE INDICATED FOR THE EVENT; THEREFORE, THE DEVICE HISTORY RECORD (DHR) COULD NOT BE REVIEWED. THE ROOT CAUSE CANNOT BE DETERMINED. ADD'L INFO HAS BEEN REQUESTED. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT FOLLOWING A GLAUCOME FILTRATION DEVICE (GFD) IMPLANTATION PROCEDURE, THE GFD WAS OBSERVED TO BE TOUCHING THE IRIS. THE GFD REMAINS IMPLANTED. ADD'L INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    733912 EX-PRESS MINI GLAUCOMA SHUNT AQUEOUS SHUNT KYF OPTONOL, LTD P-50 PL UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR