BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EX-PRESS GLAUCOMA FILTRATION DEVICE

    MDR report key: 5231400 · Received November 17, 2015

    Report

    Report Number
    3003701944-2015-00682
    Event Type
    Injury
    Date Received
    November 17, 2015
    Report Date
    November 17, 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 DEVICE HISTORY RECORD 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. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 1

    AN OPHTHALMIC SURGEON REPORTED THAT FOLLOWING A GLAUCOMA FILTRATION DEVICE (GFD) IMPLANT PROCEDURE, GFD EXPOSURE HAS OCCURRED. ADDITIONAL INFORMATION WAS PROVIDED BY THE SURGEON, WHO REPORTED THAT THE INITIAL PROCEDURE WAS A CATARACT AND GFD IMPLANT PROCEDURE. THE POSTOPERATIVE INTRAOCULAR PRESSURE WAS RELATIVELY GOOD. DURING THE FOLLOW UP PERIOD APPROXIMATELY ONE AND A HALF YEARS LATER, THE GFD WAS CONFIRMED TO BE EXPOSED FROM THE CONJUNCTIVA. DURING THE OBSERVATION, A NEEDLING WAS PERFORMED ONE TIME. THE GFD WAS REMOVED. TREATMENT IS CONTINUING WITH EYE DROP APPLICATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    759908 EX-PRESS GLAUCOMA FILTRATION DEVICE IMPLANT, EYE VALVE KYF OPTONOL LTD. P-50 PL ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 94 YR Required Intervention