BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EX-PRESS GLAUCOMA FILTRATION DEVICE

    MDR report key: 5027432 · Received August 25, 2015

    Report

    Report Number
    3003701944-2015-00627
    Event Type
    Injury
    Date Received
    August 25, 2015
    Date of Event
    December 3, 2013
    Report Date
    August 25, 2015
    Manufacturer
    OPTONOL LTD.
    Product Code
    KYF
    PMA / PMN Number
    K012852
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: NO DATA REGARDING PRODUCT IDENTITY WAS RECEIVED I.E. NO LOT OR SERIAL NUMBER WERE INDICATED FOR THE EVENT; THEREFORE, THE DEVICE HISTORY RECORD (DHR) COULD NOT BE REVIEWED. NO SAMPLE WAS RETURNED, THEREFORE, THE CONDITION OF THE PRODUCT COULD NOT BE VERIFIED. BECAUSE A SAMPLE WAS NOT RETURNED AND NO LOT NUMBER OR SERIAL NUMBER WERE INDICATED FOR THIS COMPLAINT, THE ROOT CAUSE CANNOT BE DETERMINED. ADDITIONAL INFORMATION HAS BEEN REQUESTED. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED FOLLOWING A GLAUCOMA FILTRATION DEVICE IMPLANT PROCEDURE, A PATIENT EXPERIENCED INCREASED INTRAOCULAR PRESSURE. ONE WEEK FOLLOWING THE INITIAL PROCEDURE THE PATIENT WAS TREATED WITH ADDITION MEDICATION AND THE CONJUNCTIVA WAS SUTURED DUE TO LEAKAGE OF THE AQUEOUS HUMOUR. APPROXIMATELY ONE MONTH FOLLOWING THE INITIAL PROCEDURE, SUTURE LYSIS AND NEEDLING WERE PERFORMED. THE SHUNT WAS LATER EXPLANTED AND A TRABECULECTOMY WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    561442 EX-PRESS GLAUCOMA FILTRATION DEVICE IMPLANT, EYE VALVE KYF OPTONOL LTD. P-50 PL ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Required Intervention TRAVATAN Z