BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAERVELDT SHUNT

    MDR report key: 9074170 · Received September 17, 2019

    Report

    Report Number
    9614546-2019-00868
    Event Type
    Injury
    Date Received
    September 17, 2019
    Report Date
    November 10, 2020
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    KYF
    PMA / PMN Number
    K955455
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS CORRECTION MDR IS BEING SUBMITTED TO ADDRESS INACCURATE INFORMATION IN SECTION F ON THE XML VERSION OF THE PREVIOUS SUBMISSION CAUSED BY A SOFTWARE GLITCH IN THE TRANSMISSION PROCESS. THE INTERNAL NON-CONFORMANCE NUMBERS FOR THIS SOFTWARE ISSUE ARE NR-0148919 AND CAPA-010215.

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT TESTING COULD NOT BE PERFORMED BECAUSE THE PRODUCT WAS NOT RETURNED. THE COMPLAINT CANNOT BE CONFIRMED. THE MANUFACTURING RECORD AND COMPLAINT HISTORY WERE NOT REVIEWED SINCE THE SERIAL NUMBER IS UNKNOWN. AS A RESULT OF THE INVESTIGATION THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY AND THE REPORTED ISSUE COULD NOT BE VERIFIED. A COPY OF THE LITERATURE IS BEING PROVIDED WITH THIS REPORT. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    LITERATURE TITLE: HYPERTENSIVE PHASE AND ITS ASSOCIATION WITH SURGICAL OUTCOMES IN BAERVELDT IMPLANTATION. AUTHORS: SUNEE CHANSANGPETCH, SUPAWAN SURUKRATTANASKUL, PANEEYA TAPANEEYANGKUL, VISANEE TANTISEVI INT OPHTHALMOL DOI 10.1007/S10792-017-0654-8 THE PUBLICATION REPORTED EARLY POST OPERATIVE (WITHIN 3 MONTHS) COMPLICATIONS INCLUDED: SHALLOW ANTERIOR CHAMBER: 7; CHOROIDAL DETACHMENT: 6; EXPOSED TUBE: 1; WOUND LEAK: 1; HYPHEMA: 1; VITREOUS HAEMORRHAGE: 1; PRESUMED ENDOPHTHALMITIS: 1; EXPOSED PLATE: 1. LATE POST OPERATIVE COMPLICATIONS (AFTER 3 MONTHS) INCLUDED: PERSISTENT CORNEAL EDEMA: 7; FLAT ANTERIOR CHAMBER: 2; CHOROIDAL DETACHMENT: 2; EXPOSED TUBE: 1; HYPHEMA: 1; HYPOTONY: 1; RETINAL DETACHMENT: 1. THE 2 PATIENTS WITH EXPOSED TUBE, ONE WITH EXPOSED PLATE, AND 1 WITH RECURRENT HYPHEMA ALL REQUIRED FOLLOW UP SURGERY; 3 OF WHICH LOST VISION TO NO LIGHT PERCEPTION. 16 PATIENTS REQUIRED ADDITIONAL TOPICAL ANTI-GLAUCOMA DRUGS POST SURGERY WHICH WERE SUBSEQUENTLY TAILORED OFF; HOWEVER, 4 OF THE 16 COULD NOT BE TAPERED OFF AND CONTINUED TO NEED 3 OR MORE MEDICATIONS TO CONTROL THE IOP (INTRAOCULAR PRESSURE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    871691 BAERVELDT SHUNT SURGICAL ADJUNCTS KYF JOHNSON & JOHNSON SURGICAL VISION, INC. BG103-250

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention