BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EX-PRESS GLAUCOMA FILTRATION DEVICE

    MDR report key: 6976013 · Received October 25, 2017

    Report

    Report Number
    3003701944-2017-00164
    Event Type
    Injury
    Date Received
    October 25, 2017
    Date of Event
    December 1, 2014
    Report Date
    November 27, 2017
    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: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. NO FURTHER INFORMATION IS EXPECTED. (B)(4).

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THERE WAS NO DATA REGARDING PRODUCT IDENTITY WAS RECEIVED I.E. NO LOT OR SERIAL NUMBER WERE INDICATED FOR THE EVENT; THEREFORE, THE DEVICE HISTORY RECORD/S (DHR) COULD NOT BE REVIEWED. THERE WAS NO SAMPLE RETURNED, THEREFORE, THE CONDITION OF THE PRODUCT COULD NOT BE VERIFIED. SINCE A SAMPLE WAS NOT RETURNED AND NO LOT NUMBER OR SERIAL NUMBER WERE INDICATED FOR THIS COMPLAINT, THE ROOT CAUSE COULD NOT BE DETERMINED. (B)(4).

    Description of Event or Problem · 1

    A LITERATURE ARTICLE REVIEWED CASES OF GLAUCOMA FILTRATION DEVICE (GFD) EXPOSURE. THE FEATURES OF CASES EXPOSED TO THE CONJUNCTIVA AFTER THE GFD INSERTION WERE EXAMINED. THIS WAS A RETROSPECTIVE STUDY OF 169 EYES IN 151 PATIENTS WHO UNDERWENT GFD INSERTION FROM APRIL 2012 TO APRIL 2017. EXPOSURE TIME, INTRAOCULAR PRESSURE BEFORE EXPOSURE, COURSE OF TREATMENT , SHAPE OF FILTRATION BLEB, AND INTRAOCULAR PRESSURE AFTER EXPOSURE. THIS REPORT IS FOR CASE 2, A (B)(6) MALE WHO HAS SECONDARY OPEN ANGLE GLAUCOMA WHO HAD A GLAUCOMA FILTRATION DEVICE (GFD) IMPLANTED. ONE MONTH POSTOPERATIVE GLAUCOMA DROPS WERE RESTARTED AND A NEEDLING PROCEDURE WAS PERFORMED. CONJUNCTIVAL EXPOSURE OF THE GFD WAS OBSERVED APPROXIMATELY 10 MONTHS FOLLOWING THE GFD IMPLANT PROCEDURE. APPROXIMATELY ONE MONTH LATER, THE GFD WAS EXPLANTED AND RECONSTRUCTION OF THE FILTRATION BLEB WAS PERFORMED. THERE ARE FOUR MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS ARTICLE. THIS REPORT IS FOR CASE TWO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    757043 EX-PRESS GLAUCOMA FILTRATION DEVICE IMPLANT, EYE VALVE KYF OPTONOL LTD. P-50 PL ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention