BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EX-PRESS MINI GLAUCOMA SHUNT

    MDR report key: 3042912 · Received March 5, 2013

    Report

    Report Number
    3003701944-2013-00017
    Event Type
    Malfunction
    Date Received
    March 5, 2013
    Report Date
    February 5, 2013
    Manufacturer
    OPTONOL, LTD
    Product Code
    KYF
    PMA / PMN Number
    K030350
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: 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 RELEASE CRITERIA. BECAUSE A SAMPLE WAS NOT RETURNED, THE ROOT CAUSE CANNOT BE DETERMINED. THERE HAS BEEN ONE OTHER SIMILAR COMPLAINT REPORTED IN THE LOT NUMBER. ADDITIONAL INFO HAS BEEN REQUESTED. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT AFTER A GLAUCOMA FILTRATION DEVICE IMPLANTATION, HE OBSERVED THAT IT WAS NOT DRAINING. HE REMOVED THE GLAUCOMA FILTRATION DEVICE AND COMPLETED THE SURGERY WITH ANOTHER ONE. THE PT HAD A GOOD OUTCOME WITHOUT ANY COMPLICATIONS. ADDITIONAL INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    94651 EX-PRESS MINI GLAUCOMA SHUNT AQUEOUS SHUNT KYF OPTONOL, LTD P-50 PL 120513

    Patients

    Seq Age Sex Outcome Treatment
    1