BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EX-PRESS MINI GLAUCOMA SHUNT

    MDR report key: 3233813 · Received July 16, 2013

    Report

    Report Number
    3003701944-2013-00057
    Event Type
    Injury
    Date Received
    July 16, 2013
    Date of Event
    September 18, 2012
    Report Date
    June 21, 2013
    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
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO SAMPLE WAS RETURNED, 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 OPTONOL'S RELEASE CRITERIA. THERE HAVE BEEN NO OTHER SIMILAR COMPLAINTS REPORTED IN THE LOT NUMBER. ADDITIONAL INFO HAS BEEN REQUESTED. (B)(4).

    Description of Event or Problem · 1

    A USER FACILITY REPORTED THAT FOLLOWING A GLAUCOMA FILTRATION SHUNT PLACEMENT, IT WAS NOTED THAT THE TIP OF THE SHUNT WAS INSERTED INTO THE VITREOUS CAVITY. THE PT'S INTRAOCULAR PRESSURE WAS NOTED TO BE ELEVATED AT TWO POSTOPERATIVE VISITS AND THIS WAS TREATED WITH MEDICATIONS. THE SHUNT REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328779 EX-PRESS MINI GLAUCOMA SHUNT AQUEOUS SHUNT KYF OPTONOL, LTD P-50 PL 122407

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention