BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EX-PRESS GLAUCOMA FILTRATION DEVICE

    MDR report key: 6009167 · Received October 6, 2016

    Report

    Report Number
    3003701944-2016-00187
    Event Type
    Injury
    Date Received
    October 6, 2016
    Report Date
    October 6, 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

    A SAMPLE DEVICE WAS NOT RETURNED FOR ANALYSIS. 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 WAS NOT PROVIDED. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED IN A PRESENTATION AT A HOSPITAL IN (B)(6) THAT HE HAS EXPERIENCED SIX CASES WHERE A SCLERAL FLAP HAS OPENED AND A GLAUCOMA FILTERING SHUNT HAD TO BE EXPLANTED. HE DISCUSSED 25 PATIENTS WHO HAD FILTERING BLEB REVISIONS AT SOME POINT FOLLOWING FILTERING GLAUCOMA SHUNT IMPLANTATIONS. DURING 7 OF THOSE 25 REVISIONS, THE SHUNTS WERE EXPLANTED. THE SURGEON EXPLAINED THAT IN SOME CASES THE SHUNT DOES NOT FILTER ENOUGH TO KEEP THE INTRAOCULAR PRESSURE (IOP) LOW AND UNDER CONTROL, SO SOME SHUNTS MAY HAVE TO BE EXPLANTED, ALTHOUGH THERE MAY BE NO CAUSAL RELATIONSHIP TO THE DEVICE. ADDITIONAL INFORMATION WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    656955 EX-PRESS GLAUCOMA FILTRATION DEVICE IMPLANT, EYE VALVE KYF OPTONOL LTD. P-50 PL ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R