BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EX-PRESS MINI GLAUCOMA SHUNT

    MDR report key: 1894929 · Received November 5, 2010

    Report

    Report Number
    3003701944-2010-00027
    Event Type
    Injury
    Date Received
    November 5, 2010
    Date of Event
    January 1, 2010
    Report Date
    October 6, 2010
    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
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE PROD MET RELEASE CRITERIA. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ADD'L INFO WAS REQUESTED ON 10/7/2010, 10/11/2010, AND 10/20/2010 BY PHONE, FAX, AND MAIL. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED. (B)(4).

    Description of Event or Problem · 1

    A NURSE REPORTED THAT A GLAUCOMA SHUNT CLOGGED IMMEDIATELY AFTER IT WAS PLACED IN THE EYE. THE SURGEON REMOVED THE SHUNT AND PERFORMED A TRADITIONAL TRABECULECTOMY. THE SHUNT WAS LOST DURING THE PROCEDURE. ADD'L INFO HAS BEEN REQUESTED.

    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 095238

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention