BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EX-PRESS MINI GLAUCOMA SHUNT

    MDR report key: 3780731 · Received April 22, 2014

    Report

    Report Number
    3003701944-2014-00060
    Event Type
    Injury
    Date Received
    April 22, 2014
    Date of Event
    February 8, 2013
    Report Date
    March 25, 2014
    Manufacturer
    OPTONOL, LTD
    Product Code
    KYF
    PMA / PMN Number
    K030350
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED; THE GLAUCOMA FILTRATION DEVICE REMAINS IMPLANTED. THEREFORE, THE CONDITION OF THE PRODUCT COULD NOT BE VERIFIED AND VISUAL INSPECTION CANNOT BE PERFORMED. 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 ROOT CAUSE CANNOT BE DETERMINED AND NO ACTIONS ARE TAKEN. THERE HAS BEEN ONE OTHER SIMILAR COMPLAINT REPORTED IN THE LOT NUMBER. NO FURTHER INFORMATION IS EXPECTED. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT A PATIENT HAD INCREASED INTRAOCULAR PRESSURE (IOP) OF 46MMHG FOLLOWING AN IMPLANTATION OF A GLAUCOMA FILTRATION DEVICE (GFD) BECAUSE THE GFD WAS CLOGGED BY FIBRIN. THE GFD WAS IN CONTACT WITH THE IRIS, CONJUNCTIVAL DEHISCENCE WAS OBSERVED, AND FIBRIN WAS ALSO OBSERVED IN THE ANTERIOR CHAMBER AFTER A HYPHEMA OCCURRED BECAUSE OF NEOVASCULAR GLAUCOMA. A SUTURE LYSIS WAS PERFORMED. THE EVENT RESOLVED AFTER A LASER WAS PERFORMED ON THE APERTURE OF THE GFD. THE GFD REMAINS IMPLANTED. NO FURTHER INFORMATION IS EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244137 EX-PRESS MINI GLAUCOMA SHUNT AQUEOUS SHUNT KYF OPTONOL, LTD P-50 PL 122709

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention DIAMOX| TRUSOPT| SAMPILO| FLOMOX (100)| SAMBETASON| CRAVIT| DUOTRAV