BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAERVELDT SHUNT

    MDR report key: 9178164 · Received October 11, 2019

    Report

    Report Number
    9614546-2019-00962
    Event Type
    Injury
    Date Received
    October 11, 2019
    Report Date
    November 9, 2020
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    KYF
    PMA / PMN Number
    K955455
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    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

    AGE/DATE OF BIRTH: EXACT AGES UNKNOWN, NOT PROVIDED. SEX/GENDER: UNKNOWN/ NOT PROVIDED. DATE OF EVENT: UNKNOWN, NOT PROVIDED. MODEL#: UNKNOWN/NOT PROVIDED. SERIAL#: UNKNOWN/NOT PROVIDED. CATALOG#: CATALOG # IS UNKNOWN, AS PRODUCT SERIAL NUMBER WAS NOT PROVIDED. EXPIRATION DATE: UNKNOWN AS PRODUCT SERIAL NUMBER WAS NOT PROVIDED. UDI #: UDI # IS UNKNOWN AS PRODUCT SERIAL NUMBER WAS NOT PROVIDED. IF IMPLANTED; GIVE DATE: UNKNOWN/NOT PROVIDED. IF EXPLANTED; GIVE DATE: UNKNOWN/NOT PROVIDED. PHONE: UNKNOWN, INFORMATION NOT PROVIDED. THE SHUNT PRODUCTS ARE NOT RETURNING FOR EVALUATION. THERE WAS NO SERIAL NUMBER REPORTED FOR THIS DEVICE; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. A REVIEW OF THE DEVICE HISTORY RECORD AND COMPLAINT TRENDING, FOR THIS DEVICE WILL NOT BE PERFORMED. DEVICE MANUFACTURE DATE: UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. (B)(4). CITATION: ISLAMAJ E, JORDAAN-KUIP CP, VERMEER KA, LEMIJ HG, DE WAARD PWT. MOTILITY CHANGES AND DIPLOPIA AFTER BAERVELDT GLAUCOMA DRAINAGE DEVICE IMPLANTATION OR AFTER TRABECULECTOMY. TRANS VIS SCI TECH. 2018. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    THE FOLLOWING ARTICLE WAS RECEIVED BASED ON A LITERATURE REVIEW: ARTICLE: MOTILITY CHANGES AND DIPLOPIA AFTER BAERVELDT GLAUCOMA DRAINAGE DEVICE IMPLANTATION OR AFTER TRABECULECTOMY. THE PUBLICATION REPORTS 14 PATIENTS DEVELOPED DIPLOPIA. A COPY OF THE ARTICLE IS PROVIDED WITH THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    972536 BAERVELDT SHUNT SURGICAL ADJUNCTS KYF JOHNSON & JOHNSON SURGICAL VISION, INC. BG101-350

    Patients

    Seq Age Sex Outcome Treatment
    1 Other