BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EX-PRESS MINI GLAUCOMA SHUNT

    MDR report key: 4053381 · Received August 27, 2014

    Report

    Report Number
    3003701944-2014-00150
    Event Type
    Malfunction
    Date Received
    August 27, 2014
    Date of Event
    July 31, 2014
    Report Date
    August 1, 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 SAMPLE WAS RETURNED FOR ANALYSIS, AND TRANSFERRED FOR VISUAL INSPECTION. INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ADDITIONAL INFORMATION HAS BEEN REQUESTED. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT DURING A GLAUCOMA FILTRATION DEVICE IMPLANT PROCEDURE, THERE WAS NO FLOW OR AQUEOUS HUMOR. IT WAS SUSPECTED THAT THE DEVICE WAS CLOGGED BY MATERIAL ADHERING TO THE OPERATING OF THE DEVICE. THE MATERIAL WAS REMOVED FROM THE DEVICE DURING THE PROCEDURE. THE SHUNT WAS REMOVED DURING THE INITIAL PROCEDURE. MATERIAL THAT RESEMBLED METAL PIECES WERE FOUND IN THE ANTERIOR CHAMBER OF THE EYE AFTER INFUSING BSS. THE FOREIGN MATERIAL WAS REMOVED FROM THE ANTERIOR CHAMBER DURING SURGERY. A TRABECULECTOMY WAS PERFORMED AFTER THE DEVICE WAS REMOVED. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    522528 EX-PRESS MINI GLAUCOMA SHUNT AQUEOUS SHUNT KYF OPTONOL LTD. P-50 PL 141903

    Patients

    Seq Age Sex Outcome Treatment
    1 BSS