BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EX-PRESS GLAUCOMA FILTRATION DEVICE

    MDR report key: 5647281 · Received May 11, 2016

    Report

    Report Number
    3003701944-2016-00111
    Event Type
    Injury
    Date Received
    May 11, 2016
    Report Date
    May 11, 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
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: IN A LITERATURE REPORT, THERE WERE MULTIPLE GLAUCOMA FILTRATION DEVICE (GFD) CASES ASSOCIATED WITH ENDOPHTHALMITIS, DEVICE EROSION, HYPOTONY, MALPOSITION, EXPOSURE, AND EXPLANTATION. CURRENT LITERATURE SUGGESTS TRADITIONAL TRABECULECTOMY AND GFD IMPLANTATION HAVE SIMILAR IOP LOWERING EFFICACY AND SUCCESS RATES. HOWEVER, THE GFD PROCEDURE MAY BE BETTER TOLERATED WITH A LOWER REPORTED INCIDENCE OF HYPOTONY AND HYPHEMA. IN ADDITION, RETROSPECTIVE AND PROSPECTIVE STUDIES HAVE SHOWN FASTER VISION RECOVERY WITH GFD IMPLANTATION COMPARED WITH TRABECULECTOMY. DESPITE THESE SAFETY ADVANTAGES, THE GFD IMPLANT CAN BE ASSOCIATED WITH DEVICE SPECIFIC COMPLICATIONS INCLUDING MALPOSITION OR EXPOSURE. THE ARTICLE DID NOT PROVIDE DATA REGARDING PRODUCT IDENTITY WAS RECEIVED I.E. NO LOT OR SERIAL NUMBER WERE INDICATED FOR THE EVENT; THEREFORE, THE DEVICE HISTORY RECORD (DHR) COULD NOT BE REVIEWED. THE SAMPLE WAS NOT RETURNED, THEREFORE, THE CONDITION OF THE PRODUCT COULD NOT BE VERIFIED. THE PRODUCT INVESTIGATION COULD NOT IDENTIFY A ROOT CAUSE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BY MAIL. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 1

    IN A LITERATURE ARTICLE, THE AUTHORS REPORTED THAT UPON LITERATURE REVIEW, ONLY 2 CASES OF POSTOPERATIVE ENDOPHTHALMITIS ASSOCIATED WITH THE GLAUCOMA FILTRATION DEVICE (GFD) PLACED UNDER THE SCLERAL FLAP HAVE BEEN REPORTED TO OUR KNOWLEDGE. NEITHER OF THESE CASES WERE ASSOCIATED WITH CORNEAL INFILTRATE ADJACENT TO THE DEVICE, AND ONLY 1 CASE WAS MANAGED BY REMOVAL OF THE GFD. THE AUTHORS DISCUSSION INDICATES THAT THE EARLY USE OF THE GFD WAS AS A FULL THICKNESS DRAINAGE DEVICE IMPLANTED SUBCONJUNCTIVALLY. UNFORTUNATELY, EARLY USE OF THE DEVICE IN THIS MANNER WAS ASSOCIATED WITH MANY COMPLICATIONS SUCH AS DEVICE EROSION, HYPOTONY AND ENDOPHTHALMITIS, WHICH LED TO ABANDONMENT OF THIS METHOD AND THE DEVELOPMENT OF THE CURRENT TECHNIQUE OF PLACING THE DEVICE UNDER A PARTIAL-THICKNESS SCLERAL FLAP. CURRENT LITERATURE SUGGESTS TRADITIONAL TRABECULECTOMY AND GFD IMPLANTATION HAVE SIMILAR IOP LOWERING EFFICACY AND SUCCESS RATES. HOWEVER, THE GFD PROCEDURE MAY BE BETTER TOLERATED WITH A LOWER REPORTED INCIDENCE OF HYPOTONY AND HYPHEMA. IN ADDITION, RETROSPECTIVE AND PROSPECTIVE STUDIES HAVE SHOWN FASTER VISION RECOVERY WITH GFD IMPLANTATION COMPARED WITH TRABECULECTOMY. DESPITE THESE SAFETY ADVANTAGES, THE GFD IMPLANT CAN BE ASSOCIATED WITH DEVICE SPECIFIC COMPLICATIONS INCLUDING MALPOSITION OR EXPOSURE. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS LITERATURE ARTICLE. THIS REPORT IS FOR THE MULTIPLE CASES OF COMPLICATIONS IN THE LITERATURE ARTICLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302213 EX-PRESS GLAUCOMA FILTRATION DEVICE IMPLANT, EYE VALVE KYF OPTONOL LTD. UNK ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R