BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EX-PRESS GLAUCOMA FILTRATION DEVICE

    MDR report key: 5755386 · Received June 28, 2016

    Report

    Report Number
    3003701944-2016-00149
    Event Type
    Injury
    Date Received
    June 28, 2016
    Date of Event
    September 22, 2012
    Report Date
    July 22, 2016
    Manufacturer
    OPTONOL LTD.
    Product Code
    KYF
    PMA / PMN Number
    K012852
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS; THE GFD REMAINS IMPLANTED. 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. NO SAMPLE WAS RETURNED, THEREFORE, THE CONDITION OF THE PRODUCT COULD NOT BE VERIFIED AND VISUAL INSPECTION CANNOT BE PERFORMED. THE PRODUCT INVESTIGATION COULD NOT IDENTIFY A ROOT CAUSE. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ADDITIONAL INFORMATION HAS BEEN REQUESTED. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS PROVIDED BY THE SURGEON, WHO REPORTED THAT DURING A 24-36 MONTH POSTOPERATIVE EXAM AN ADVANCED CATARACT WAS OBSERVED REQUIRING CATARACT SURGERY. AT 36 MONTHS FOLLOWING THE GLAUCOMA FILTRATION DEVICE (GFD) IMPLANTATION THE GFD IS EXPOSED AND THAT THERE WAS SCLERAL THINNING. APPROXIMATELY TWO MONTHS LATER, THE EVENT CONTINUES.

    Description of Event or Problem · 1

    AN OPHTHALMOLOGIST REPORTED THAT APPROXIMATELY FOUR YEARS FOLLOWING A GLAUCOMA FILTRATION DEVICE (GFD) IMPLANT PROCEDURE, THE GFD IS BECOMING TRANSPARENT THROUGH THE SCLERA AND THE SCLERA IS THINNING. ADDITIONAL INFORMATION WAS PROVIDED BY THE SURGEON, WHO REPORTED THAT ON THE FIRST POSTOPERATIVE DAY THE GFD WAS OBSERVED TO BE TOUCHING THE IRIS AND A SUTURE LYSIS WAS PERFORMED. FIVE DAYS LATER ANOTHER SUTURE LYSIS WAS PERFORMED. APPROXIMATELY TWO WEEKS LATER, THE INTRAOCULAR PRESSURE (IOP) INCREASED, A SUTURE LYSIS AND NEEDLING WITH MITOMYCIN C WAS PERFORMED. SEVEN WEEKS LATER, A SECOND NEEDLING WITH MITOMYCIN C WAS PERFORMED. APPROXIMATELY 4 MONTHS LATER, OPHTHALMIC DROPS TO TREAT THE INTRAOCULAR PRESSURE WERE STARTED. THE INCREASED IOP RECOVERED WITH MEDICATION TREATMENT. THE FILTERING BLEB DISORDER DESCRIBED AS FIBROSIS OF THE FILTERING BLEB WERE NOT RELATED TO THE GFD ACCORDING TO THE SURGEON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    408901 EX-PRESS GLAUCOMA FILTRATION DEVICE IMPLANT, EYE VALVE KYF OPTONOL LTD. P-50 PL 122405

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Other| R