BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EX-PRESS MINI GLAUCOMA SHUNT

    MDR report key: 3960129 · Received July 17, 2014

    Report

    Report Number
    3003701944-2014-00112
    Event Type
    Injury
    Date Received
    July 17, 2014
    Date of Event
    April 1, 2013
    Report Date
    June 19, 2014
    Manufacturer
    OPTONOL, LTD
    Product Code
    KYF
    PMA / PMN Number
    K030350
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    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 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. THE ROOT CAUSE CANNOT BE DETERMINED. THERE HAVE BEEN NO OTHER SIMILAR COMPLAINTS REPORTED IN THE LOT NUMBER. ADDITIONAL INFORMATION HAS BEEN REQUESTED. (B)(4).

    Description of Event or Problem · 1

    AN OPHTHALMIC SURGEON REPORTED THAT FOLLOWING A GLAUCOMA FILTRATION DEVICE (GFD) IMPLANT PROCEDURE, THE GFD TOUCHED TO THE IRIS THE FIRST DAY AFER THE SURGERY. SUTURE LYSIS WERE PERFORMED FIVE TIMES AFTER THE SURGERY AND AN OPHTHALMIC MEDICATION WAS USED TO TREAT THE GLAUCOMA POSTOPERATIVELY. FIBROSIS OF FILTERING BLEB WAS FOUND A MONTH AFTER THE SURGERY AND A NEEDLING REVISION WITH A METABOLIC INHIBITOR WAS PERFORMED. THE GFD WAS NO LONGER IN CONTACT WITH THE IRIS AT THE 12 WEEK POSTOPERATIVE VISIT. THE OUTCOME OF THE EVENT IS DOCUMENTED AS RECOVERING. THE GFD HAS REMAINED IN THE EYE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    417864 EX-PRESS MINI GLAUCOMA SHUNT AQUEOUS SHUNT KYF OPTONOL, LTD P-50 PL 122709

    Patients

    Seq Age Sex Outcome Treatment
    1 MITOMYCIN C