BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EX-PRESS MINI GLAUCOMA SHUNT

    MDR report key: 3770899 · Received December 19, 2013

    Report

    Report Number
    3003701944-2013-00127
    Event Type
    Injury
    Date Received
    December 19, 2013
    Date of Event
    November 20, 2013
    Report Date
    November 25, 2013
    Manufacturer
    OPTONOL, LTD
    Product Code
    KYF
    PMA / PMN Number
    K030350
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE PRODUCT WAS RETURNED FOR ANALYSIS. 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 FOLLOWING A GLAUCOMA FILTRATION DEVICE (GDF) IMPLANT PROCEDURE, A NEEDLING PROCEDURE WAS PERFORMED BECAUSE THE BLEB HAD DISAPPEARED. THE FLAP WAS OPENED AND A NEEDLING PROCEDURE WAS PERFORMED ON TWO OCCASIONS. THE GDF WAS LATER REMOVED BECAUSE THE AQUEOUS HUMOR DID NOT COME FROM THE ANTERIOR, ALTHOUGH THE FLAP WAS OPENED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    667581 EX-PRESS MINI GLAUCOMA SHUNT AQUEOUS SHUNT KYF OPTONOL, LTD P-50 PL 122620

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention