BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EX-PRESS GLAUCOMA FILTRATION DEVICE

    MDR report key: 8257819 · Received January 17, 2019

    Report

    Report Number
    3003701944-2019-00004
    Event Type
    Malfunction
    Date Received
    January 17, 2019
    Date of Event
    December 20, 2018
    Report Date
    April 3, 2019
    Manufacturer
    OPTONOL LTD.
    Product Code
    KYF
    PMA / PMN Number
    K012852
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE SAMPLE WAS RECEIVED AND ITS INVESTIGATION MAY BE SUMMARIZED AS FOLLOWS: THE DELIVERY SYSTEM (DS) WIRE WAS PRESSED DOWN. THE DS WIRE PARTIALLY PROTRUDED FROM THE CANNULA OPENING. THE SHUNT WAS SENT IN A SEPARATE PLASTIC BAG. THE DEVICE HISTORY RECORD (DHR) FOR THE BATCH WAS REVIEWED. NO ABNORMALITIES WERE FOUND DURING THE DHR REVIEW AND THE PRODUCT WAS RELEASED ACCORDING TO RELEASE CRITERIA. THERE HAVE BEEN ONE SIMILAR COMPLAINT FOR THE REPORTED LOT. ALL PRODUCTS PASS 100% FINAL INSPECTION PRIOR TO APPROVAL. IF A DEFECT WOULD BE NOTICED, THE PRODUCT WOULD HAVE BEEN REJECTED. THE ROOT CAUSE CANNOT BE IDENTIFIED AS THE DS TRIGGER WAS OPERATED AND PERFORMED ITS FUNCTIONALITY RELEASING THE SHUNT (SHUNT WAS RECEIVED SEPARATELY FROM THE DS). THE COMPLAINT CANNOT BE CONFIRMED. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 1

    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. ADDITIONAL INFORMATION WAS REQUESTED. (B)(4).

    Description of Event or Problem · 1

    A PHYSICIAN REPORTED THAT DURING A GLAUCOMA FILTERING SHUNT PROCEDURE, THE SHUNT WOULD NOT RELEASE FROM THE DELIVERY SYSTEM WHEN INSERTED INTO A PATIENT'S EYE. ANOTHER SHUNT WAS IMPLANTED INSTEAD. THERE WAS NO REPORTED HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48405 EX-PRESS GLAUCOMA FILTRATION DEVICE IMPLANT, EYE VALVE KYF OPTONOL LTD. P-50 PL 073119

    Patients

    Seq Age Sex Outcome Treatment
    1