BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EX-PRESS GLAUCOMA FILTRATION DEVICE

    MDR report key: 5585075 · Received April 18, 2016

    Report

    Report Number
    3003701944-2016-00095
    Event Type
    Injury
    Date Received
    April 18, 2016
    Date of Event
    February 16, 2013
    Report Date
    November 11, 2016
    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
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. THE CUSTOMER REPORTED THAT CATARACT SURGERY WAS PERFORMED, APPROXIMATELY FOUR MONTHS AFTER THE SHUNT TOUCHED THE IRIS. THERE WAS 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 AND VISUAL INSPECTION CANNOT BE PERFORMED. THE PRODUCT INVESTIGATION COULD NOT IDENTIFY A ROOT CAUSE. ADDITIONAL INFORMATION HAS BEEN REQUESTED. (B)(4).

    Description of Event or Problem · 1

    AN OPHTHALMIC SURGEON REPORTED THAT FOUR DAYS FOLLOWING THE GLAUCOMA FILTRATION DEVICE (GFD) IMPLANT PROCEDURE, THE GFD WAS IN CONTACT WITH THE IRIS. THREE DAYS LATER, THE GFD WAS NO LONGER IN CONTACT WITH THE IRIS. ONE MONTH LATER, THE GFD WAS IN CONTACT WITH THE IRIS. EIGHT WEEKS LATER, THE GFD WAS NO LONGER IN CONTACT WITH THE IRIS AND A SUTURE LYSIS WAS PERFORMED. APPROXIMATELY TWO MONTHS LATER, A CATARACT WAS OBSERVED. A CATARACT SURGERY WAS PERFORMED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    239096 EX-PRESS GLAUCOMA FILTRATION DEVICE IMPLANT, EYE VALVE KYF OPTONOL LTD. P-50 PL ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Other| R