BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EX-PRESS MINI GLAUCOMA SHUNT

    MDR report key: 4265568 · Received November 18, 2014

    Report

    Report Number
    3003701944-2014-00231
    Event Type
    Injury
    Date Received
    November 18, 2014
    Date of Event
    August 2, 2012
    Report Date
    October 24, 2014
    Manufacturer
    OPTONOL, LTD
    Product Code
    KYF
    PMA / PMN Number
    K030350
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS, THEREFORE, THE CONDITION OF THE PRODUCT COULD NOT BE VERIFIED AND VISUAL INSPECTION CANNOT BE PERFORMED, THE GFD REMAINS IMPLANTED. 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. THE ROOT CAUSE CANNOT BE DETERMINED. ADDITIONAL INFORMATION HAS BEEN REQUESTED. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT THE DAY AFTER A GLAUCOMA FILTRATION DEVICE IMPLANT PROCEDURE (GFD), THE GFD WAS OBSERVED TO BE TOUCHING THE IRIS. THE PATIENT EXPERIENCED POSTOPERATIVE HYPOTONY. THE GFD REMAINS IMPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    746310 EX-PRESS MINI GLAUCOMA SHUNT AQUEOUS SHUNT KYF OPTONOL, LTD P-50 PL UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other