BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EX-PRESS GLAUCOMA FILTRATION DEVICE

    MDR report key: 4667041 · Received April 8, 2015

    Report

    Report Number
    3003701944-2015-00523
    Event Type
    Injury
    Date Received
    April 8, 2015
    Date of Event
    March 9, 2015
    Report Date
    April 8, 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: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS, THE GFD REMAINS IMPLANTED. THE DEVICE HISTORY RECORD (DHR) COULD NOT BE REVIEWED BECAUSE THE REPORTING FACILITY DID NOT PROVIDE A LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MANUFACTURING DOCUMENTATION. THE PRODUCT INVESTIGATION COULD NOT IDENTIFY A ROOT CAUSE. ADDITIONAL INFORMATION HAS BEEN REQUESTED. ZIP CODE IS NOT INDICATED AT THIS TIME. (B)(4).

    Description of Event or Problem · 1

    AN OPHTHALMIC SURGEON REPORTED THAT FOLLOWING A GLAUCOMA FILTRATION DEVICE (GFD) IMPLANT PROCEDURE, THE PATIENT WAS SUSPECTED TO HAVE CHOROIDAL DETACHMENT INDUCED BY HYPOTONY. IN THE SURGEON'S OPINION, THERE IS NO CAUSAL RELATIONSHIP BETWEEN THE SYMPTOM AND THE GFD IMPLANTATION, AND THE SAME COMPLICATION WOULD HAVE DEVELOPED EVEN IF TRABECULECTOMY HAD BEEN PERFORMED. THE GFD REMAINS IMPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231041 EX-PRESS GLAUCOMA FILTRATION DEVICE IMPLANT, EYE VALVE KYF OPTONOL LTD. P-50 PL ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Other