BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EX-PRESS MINI GLAUCOMA SHUNT

    MDR report key: 4425241 · Received January 14, 2015

    Report

    Report Number
    3003701944-2015-00010
    Event Type
    Malfunction
    Date Received
    January 14, 2015
    Date of Event
    January 1, 2014
    Report Date
    December 17, 2014
    Manufacturer
    OPTONOL, LTD
    Product Code
    KYF
    PMA / PMN Number
    K030350
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. THE DEVICE HISTORY RECORD FOR THE BATCH WAS RECEIVED AND NO ABNORMALITIES WERE FOUND. THE PRODUCT WAS RELEASED ACCORDING TO RELEASE CRITERIA. THE PRODUCT INVESTIGATION COULD NOT IDENTIFY A ROOT CAUSE. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. (B)(4).

    Description of Event or Problem · 1

    AN INTRAOCULAR LENS COORDINATOR REPORTED THAT DURING A GLAUCOMA FILTRATION DEVICE (GFD) IMPLANT PROCEDURE, THE GFD WAS NOT WORKING PROPERLY WHEN PLACED IN THE EYE. THE SURGEON REMOVED AND REPLACED THE GFD DURING THE INITIAL PROCEDURE WITH NO PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED FROM THE SURGEON, WHO REPORTED THAT WHEN HE IMPLANTED THE GFD THERE WAS NO FLOW AND THE LUMEN WAS OCCLUDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    31312 EX-PRESS MINI GLAUCOMA SHUNT AQUEOUS SHUNT KYF OPTONOL, LTD P-50-OL 141002

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR