BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EX-PRESS MINI GLAUCOMA SHUNT

    MDR report key: 4121541 · Received July 29, 2014

    Report

    Report Number
    3003701944-2014-00123
    Event Type
    Malfunction
    Date Received
    July 29, 2014
    Date of Event
    April 26, 2013
    Report Date
    July 2, 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
    PHYSICIAN

    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 THAT ONE DAY FOLLOWING A GLAUCOMA FILTRATION SHUNT IMPLANTATION, THE SHUNT WAS TOUCHING THE IRIS. THERE IS NO HARM TO THE PT. THE SHUNT REMAINS IMPLANTED. ADD'L INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    442687 EX-PRESS MINI GLAUCOMA SHUNT AQUEOUS SHUNT KYF OPTONOL, LTD P-50 PL UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR