BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EX-PRESS GLAUCOMA FILTRATION DEVICE

    MDR report key: 5585119 · Received April 18, 2016

    Report

    Report Number
    3003701944-2016-00096
    Event Type
    Malfunction
    Date Received
    April 18, 2016
    Date of Event
    March 16, 2016
    Report Date
    April 18, 2016
    Manufacturer
    OPTONOL LTD.
    Product Code
    KYF
    PMA / PMN Number
    K012852
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    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. THE SAMPLE WAS NOT RETURNED, THEREFORE THE CONDITION OF THE PRODUCT COULD NOT BE VERIFIED. THE PRODUCT INVESTIGATION COULD NOT IDENTIFY A ROOT CAUSE. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION BY PHONE AND EMAIL. (B)(4).

    Description of Event or Problem · 1

    A CLINICAL DIRECTOR REPORTED THAT DURING A GLAUCOMA FILTRATION DEVICE (GFD) IMPLANT PROCEDURE, THE GFD HAD NO FLOW, THEREFORE, THE SURGERY WAS COMPLETED BY REPLACING THE GFD WITH ANOTHER GFD. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    241221 EX-PRESS GLAUCOMA FILTRATION DEVICE IMPLANT, EYE VALVE KYF OPTONOL LTD. P-50 PL 702453

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other