BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EX-PRESS GLAUCOMA FILTRATION DEVICE

    MDR report key: 6114111 · Received November 18, 2016

    Report

    Report Number
    3003701944-2016-00216
    Event Type
    Injury
    Date Received
    November 18, 2016
    Date of Event
    November 25, 2013
    Report Date
    November 18, 2016
    Manufacturer
    OPTONOL LTD.
    Product Code
    KYF
    PMA / PMN Number
    K012852
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION 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 THE MANUFACTURER'S RELEASE CRITERIA. BECAUSE A SAMPLE WAS NOT RETURNED, THE ROOT CAUSE CANNOT BE DETERMINED. THERE HAS BEEN ONE SIMILAR COMPLAINT IN THE LOT NUMBER. ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION. (B)(4).

    Description of Event or Problem · 1

    AN OPHTHALMIC SURGEON REPORTED THAT THE PATIENT'S INTRAOCULAR PRESSURE INCREASED FOLLOWING A CATARACT EXTRACTION WITH INTRAOCULAR LENS IMPLANT/GLAUCOMA FILTRATION DEVICE IMPLANT PROCEDURE. ONE MONTH FOLLOWING THE PROCEDURE, A SUTURE LYSIS AND NEEDLING WERE PERFORMED. THREE MONTHS FOLLOWING THE PROCEDURE ANOTHER NEEDLING WAS PERFORMED. ONE YEAR FOLLOWING THE PROCEDURE A PROSTAGLANDIN AND BETA-BLOCKER/CARBONIC ANHYDRASE INHIBITOR COMBINATION TOPICAL MEDICATION WAS PRESCRIBED. APPROXIMATELY EIGHTEEN MONTHS FOLLOWING THE PROCEDURE THE PROSTAGLANDIN WAS EXCHANGED FOR ANOTHER PROSTAGLANDIN AND AN ALPHA AGONIST TOPICAL MEDICATION WAS ADDED TO THE REGIMEN. APPROXIMATELY THIRTY MONTHS FOLLOWING THE INITIAL PROCEDURE, A TRABECULECTOMY WAS PERFORMED. THE SURGEON CONSIDERED THIS EVENT TO BE NON-SERIOUS. THE CAUSAL RELATIONSHIP BETWEEN THE DEVICE AND THE EVENT IS PROBABLE. THE PATIENT IS RECOVERED. THE DEVICE REMAINS IMPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    764530 EX-PRESS GLAUCOMA FILTRATION DEVICE IMPLANT, EYE VALVE KYF OPTONOL LTD. P-50 PL 123040

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention MITOMYCIN C 0.04% APPLICATION TIME 3 MIN