BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EX-PRESS MINI GLAUCOMA SHUNT

    MDR report key: 3983333 · Received July 2, 2014

    Report

    Report Number
    3003701944-2014-00095
    Event Type
    Malfunction
    Date Received
    July 2, 2014
    Date of Event
    April 10, 2013
    Report Date
    June 10, 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: INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILE AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT FOLLOWING A GLAUCOMA FILTRATION DEVICE IMPLANT, THE DEVICE WAS FOUND TO BE TOUCHING THE IRIS THE DAY AFTER SURGERY. THERE WAS NO HARM TO THE PATIENT. THE DEVICE REMAINS IMPLANTED IN THE EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    387496 EX-PRESS MINI GLAUCOMA SHUNT AQUEOUS SHUNT KYF OPTONOL, LTD P-50 PL N1546665

    Patients

    Seq Age Sex Outcome Treatment
    1