BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EX-PRESS MINI GLAUCOMA SHUNT

    MDR report key: 3093661 · Received May 1, 2013

    Report

    Report Number
    3003701944-2013-00034
    Event Type
    Injury
    Date Received
    May 1, 2013
    Date of Event
    April 4, 2013
    Report Date
    April 4, 2013
    Manufacturer
    OPTONOL LTD.
    Product Code
    KYF
    PMA / PMN Number
    K030350
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS RETURNED FOR ANALYSIS. INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56, WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT DURING GLAUCOMA SHUNT IMPLANTATION SURGERY, THE SHUNT WOULD NOT RELEASE FROM THE DELIVERY SYSTEM BECAUSE IT WAS HARD TO PUSH THE BUTTON. A NEW SHUNT WAS USED TO COMPLETE THE PROCEDURE AND THERE WAS NO HARM TO THE PT. NO FURTHER INFORMATION IS EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    188944 EX-PRESS MINI GLAUCOMA SHUNT AQUEOUS SHUNT KYF OPTONOL LTD. P-50 PL 122922

    Patients

    Seq Age Sex Outcome Treatment
    1