BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK_GLAUCOMA SHUNT_BAERVELDT SHUNT

    MDR report key: 23986357 · Received January 6, 2026

    Report

    Report Number
    3012236936-2026-000001
    Event Type
    Injury
    Date Received
    January 6, 2026
    Report Date
    January 7, 2026
    Manufacturer
    AMO MANUFACTURING NETHERLANDS
    Product Code
    KYF
    PMA / PMN Number
    K955455
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION A2: MEAN AGE 54 ±16 YEARS SECTION A3A: 13 (48 %) FEMALE AND 14 MALE (52 %) PATIENTS SECTION A5 (RACE): WHITE, 25 (93%) PATIENTS SECTIONS A3B, A4, AND A5 (ETHNICITY): INFORMATION UNKNOWN/NOT PROVIDED. SECTION B3 - DATE OF EVENT: ARTICLE ACCEPTANCE DATE: JANUARY 20, 2024 SECTION D4 - MODEL #: UNKNOWN, AS PRODUCT SERIAL NUMBER WAS NOT PROVIDED. SECTION D4 - CATALOG #: UNKNOWN, AS PRODUCT SERIAL NUMBER WAS NOT PROVIDED. SECTION D4 - SERIAL #: UNKNOWN/ NOT PROVIDED SECTION D4 - EXPIRATION DATE: UNKNOWN, AS PRODUCT SERIAL NUMBER WAS NOT PROVIDED. SECTION D4 - UDI #: UNKNOWN, AS PRODUCT SERIAL NUMBER WAS NOT PROVIDED. SECTION D-6A DATE IMPLANTED: UNKNOWN/ NOT PROVIDED. SECTION D-6B DATE EXPLANTED: NA - DEVICE REMAINS IMPLANTED. SECTION E1 - TELEPHONE NUMBER: UNKNOWN/NOT PROVIDED SECTION H3: THE DEVICE WAS NOT RETURNED FOR EVALUATION AS IT REMAINS IMPLANTED. THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. AS THE SERIAL NUMBER IS UNKNOWN NO FURTHER INVESTIGATION CAN BE PERFORMED. IF THERE IS ANY RELEVANT INFORMATION RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE FILED. SECTION H4 - DEVICE MANUFACTURE DATE: UNKNOWN, AS PRODUCT SERIAL NUMBER WAS NOT PROVIDED. CITATION: BERTELOOT, S., BARAO, R. C., PINTO, L. A. (2024). TREATMENT OUTCOMES COMPARING THE PAUL AND BAERVELDT GLAUCOMA IMPLANTS AFTER ONE YEAR OF FOLLOW-UP. GLAUCOMA JOURNAL, VOLUME 33, NUMBER 8 (594 - 600). DOI: 10.1097/IJG.0000000000002366. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    THE LITERATURE ARTICLE BELOW WAS RECEIVED ON 12/10/2025 WITH POTENTIAL COMPLICATIONS/AES REPORTED. LITERATURE TITLE: TREATMENT OUTCOMES COMPARING THE PAUL AND BAERVELDT GLAUCOMA IMPLANTS AFTER ONE YEAR OF FOLLOW-UP. A RETROSPECTIVE COMPARATIVE STUDY WAS DONE TO COMPARE EFFICACY AND SAFETY PROFILES OF THE PAUL GLAUCOMA IMPLANT (PGI) AND BAERVELDT GLAUCOMA IMPLANT (BGI) IN THE TREATMENT OF MEDICALLY UNCONTROLLED GLAUCOMA AT 1 YEAR OF FOLLOW-UP. A TOTAL OF 50 PATIENTS (N= 50 EYES) WERE INCLUDED AND WERE DIVIDED INTO THOSE IMPLANTED WITH PGI (N= 23 EYES) AND BGI (N=27 EYES). BOTH GROUPS WITH GLAUCOMA IMPLANT TYPES WERE IMPLANTED IN THE SUPERIOR TEMPORAL QUADRANT, WITH THE TUBE INSERTED INTO THE ANTERIOR CHAMBER (AC), THE SULCUS, OR THE VITREOUS CAVITY. COMPLICATIONS INCLUDED: EARLY POSTOPERATIVE COMPLICATIONS INCLUDED: CHOROIDAL EFFUSION (N=3) HYPHEMA (N=3) VITREOUS CAVITY BLEEDING (N=2) NEW ONSET CORNEAL DECOMPENSATION (N=1) STENT EXPOSURE (TRANSCONJUNCTIVAL) (N=1) WOUND LEAK (N=1) LATE POSTOPERATIVE COMPLICATIONS WERE: SHALLOW OR FLAT ANTERIOR CHAMBER (AC) (N=1) CHOROIDAL EFFUSION (N=3) HYPOTONY MACULOPATHY (N=2) HYPHEMA (N=3) VITREOUS CAVITY BLEEDING (N=1) INCREASED LENS OPACITY (N=1) NEW ONSET CORNEAL DECOMPENSATION (N=2) REQUIRING CORNEAL SURGERY DURING FOLLOW-UP (N=1) STENT EXPOSURE (TRANSCONJUNCTIVAL) (N=1) IN THE BGI GROUP, THE VISION CHANGE (LOSS OF MORE THAN 2 SNELLEN LINES; N=5) WAS RELATED TO GLAUCOMA PROGRESSION (N=2), PERSISTENT HYPOTONY (N=1) WHICH RESOLVED SPONTANEOUSLY, CORNEAL DECOMPENSATION (N=2, ONE OF WHICH WAS THE ONE WITH INTRAVITREAL BLEEDING). A COPY OF THE ARTICLE IS ATTACHED TO THIS REPORT

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47156 UNK_GLAUCOMA SHUNT_BAERVELDT SHUNT IMPLANT, EYE VALVE KYF AMO MANUFACTURING NETHERLANDS UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other