BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EX-PRESS GLAUCOMA FILTRATION DEVICE

    MDR report key: 8142750 · Received December 7, 2018

    Report

    Report Number
    3003701944-2018-00059
    Event Type
    Injury
    Date Received
    December 7, 2018
    Report Date
    January 7, 2019
    Manufacturer
    OPTONOL LTD.
    Product Code
    KYF
    PMA / PMN Number
    K012852
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    EVALUATION SUMMARY: COMPLAINT TREND REVIEW HAS BEEN PERFORMED FOR THE UPDATED EVENT CODES: SHUNT NOT DRAINING PROPERLY DURING IMPLANT PROCEDURE, P-PROCEDURE-ENLARGED INCISION AND P-REMOVAL-NON IOL, DURING INITIAL PROCEDURE. ONE OTHER COMPLAINT WITH THE SAME CODE "FILTRATION ISSUE" FOR THE SAME LOT. THE ROOT CAUSE CANNOT BE DETERMINED AS NO SAMPLED HAD BEEN RETURNED. THEREFORE, THE COMPLAINT CANNOT BE CONFIRMED. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. 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. NO SAMPLE WAS RETURNED, THEREFORE, THE CONDITION OF THE PRODUCT COULD NOT BE VERIFIED AND VISUAL INSPECTION CANNOT BE PERFORMED. THE PRODUCT INVESTIGATION COULD NOT IDENTIFY A ROOT CAUSE. THERE HAVE BEEN NO OTHER SIMILAR COMPLAINTS REPORTED IN THE LOT NUMBER. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 1

    A FACILITY REPRESENTATIVE REPORTED THAT DURING A GLAUCOMA FILTRATION DEVICE (GDF) PROCEDURE, THE DEVICE WAS DEFECTIVE AS THERE WAS NO FILTRATION. THE INCISION WAS INCREASED TO REMOVE THE GFD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    983474 EX-PRESS GLAUCOMA FILTRATION DEVICE IMPLANT, EYE VALVE KYF OPTONOL LTD. P-50 PL 072746

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention