BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EX-PRESS MINI GLAUCOMA SHUNT

    MDR report key: 2822502 · Received November 2, 2012

    Report

    Report Number
    3003701944-2012-00076
    Event Type
    Injury
    Date Received
    November 2, 2012
    Date of Event
    September 25, 2012
    Report Date
    October 4, 2012
    Manufacturer
    OPTONOL, LTD
    Product Code
    KYF
    PMA / PMN Number
    K0300350
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR ANALYSIS; THEREFORE, THE CONDITION OF THE PRODUCT COULD NOT BE VERIFIED AND VISUAL INSPECTION COULD NOT BE PERFORMED. THERE WERE NO OTHER COMPLAINTS REPORTED IN THE LOT. THE ROOT CAUSE COULD NOT BE DETERMINED. (B)(4).

    Description of Event or Problem · 1

    A USER FACILITY REPORTED THAT A GLAUCOMA SHUNT WAS NOT DRAINING PROPERLY. ONE WEEK FOLLOWING IMPLANTATION, THE SHUNT WAS EXPLANTED AND A TRABECULECTOMY WAS PERFORMED. ADD'L INFO WAS RECEIVED FROM THE SURGEON, WHO INDICATED THE EVENT RESOLVED FOLLOWING THE SHUNT EXPLANTATION AND TRABECULECTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EX-PRESS MINI GLAUCOMA SHUNT AQUEOUS SHUNT KYF OPTONOL, LTD R-50 PL 121211

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention 9.0 NYLON| MITOMYCIN C| WESCOTT SCISSORS| 2 MILIMETER (MM) CRESENT KNIFE| 8.0 VICRYL