BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EX-PRESS GLAUCOMA FILTRATION DEVICE

    MDR report key: 7490804 · Received May 7, 2018

    Report

    Report Number
    3003701944-2018-00024
    Event Type
    Injury
    Date Received
    May 7, 2018
    Report Date
    May 7, 2018
    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

    EVALUATION SUMMARY: NO SAMPLE WAS RECEIVED; THEREFORE, THE CONDITION OF THE PRODUCT COULD NOT BE VERIFIED. 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 (DHR) COULD NOT BE REVIEWED. THE PRODUCT INVESTIGATION COULD NOT IDENTIFY A ROOT CAUSE. (B)(4).

    Description of Event or Problem · 1

    IN A LITERATURE ARTICLE, THE AUTHORS COMPARED EARLY POSTOPERATIVE COMPLICATION BETWEEN TRABECULECTOMY AND THE GLAUCOMA FILTRATION DEVICE (GFD) IMPLANTATION. ENROLLED PATIENTS WITH 39 PRIMARY OPEN ANGLE GLAUCOMA OR 25 EXFOLIATIVE GLAUCOMA WERE RANDOMLY ASSIGNED TO RECEIVE A TRABECULECTOMY OR GFD IMPLANTATION. THE AUTHORS REPORTED THAT 5 EYES IN THE GFD GROUP HAD HIGH FLARE VALUES, 3 EYES HAD FLAT ANTERIOR CHAMBERS, 6 EYES HAD CHOROIDAL DETACHMENT AND 1 EYE WITH HYPOTONIC MACULOPATHY. THE GFD GROUP OCULAR MASSAGE WAS PERFORMED IN 19 OF 32 PATIENT, LASER SUTURE LYSIS WAS PERFORMED IN 24 OF 32 EYES AND BLEB REVISION WITH NEEDLING PERFORMED IN 3 OF 32 EYES. FIFTEEN OF 32 EYES IN THE GFD GROUP HAD IRIS CONTACT WITH THE GFD TUBE AFTER SURGERY. THE EYES THAT HAD IRIS CONTACT HAD SIGNIFICANTLY SHALLOWER ANTERIOR CHAMBERS THAN DID THE EYES THAT DID NOT HAVE IRIS CONTACT. ALL SEVEN EYES WITH A PREOPERATIVE ANTERIOR CHAMBER DEPTH OF < OR EQUAL TO 2.61 MM DEVELOPED IRIS CONTACT WITH THE TUBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333221 EX-PRESS GLAUCOMA FILTRATION DEVICE IMPLANT, EYE VALVE KYF OPTONOL LTD. P-50 PL ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R