BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK_GLAUCOMA SHUNT_BAERVELDT SHUNT

    MDR report key: 24028726 · Received January 9, 2026

    Report

    Report Number
    3012236936-2026-000008
    Event Type
    Injury
    Date Received
    January 9, 2026
    Report Date
    January 9, 2026
    Manufacturer
    AMO MANUFACTURING NETHERLANDS
    Product Code
    KYF
    PMA / PMN Number
    K955455
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION A2: MEAN AGE: 61.6 ± 12.9 . SECTION A3: FEMALE: 67 (30.0%); MALE 156 (70.0%). SECTIONS A4, A5: INFORMATION UNKNOWN/NOT PROVIDED. SECTION B3 - DATE OF EVENT: ARTICLE ACCEPTANCE DATE: JAN 27, 2025 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: UNKNOWN/NOT PROVIDED. SECTION H3: THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE SERIAL NUMBER FOR THIS DEVICE IS NOT AVAILABLE; THEREFORE, NO FURTHER INVESTIGATION CAN BE PERFORMED. IF THERE IS ANY FURTHER RELEVANT INFORMATION RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE FILED. SECTION H4 - DEVICE MANUFACTURE DATE: UNKNOWN, AS PRODUCT SERIAL NUMBER WAS NOT PROVIDED. SECTION H6 - DEVICE CODE(S): 3191 NO CODE AVAILABLE, EVENT IS UNSPECIFIED WITH PATIENT INVOLVEMENT. SECTION H6 - HEALTH EFFECT - IMPACT CODE: 4625 FOR SECONDARY SURGICAL INTERVENTION, SUTURES, AND UNPLANNED VITRECTOMY. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    THE FOLLOWING ARTICLE WAS RECEIVED BASED ON A LITERATURE REVIEW: ARTICLE: SURGICAL OUTCOMES OF BAERVELDT GLAUCOMA IMPLANT VERSUS AHMED GLAUCOMA VALVE IN NEOVASCULAR GLAUCOMA: A RETROSPECTIVE MULTICENTER STUDY. A MULTICENTER RETROSPECTIVE STUDY WAS DONE TO COMPARE THE SURGICAL OUTCOMES OF BAERVELDT GLAUCOMA IMPLANT (BGI) SURGERY WITH THOSE OF AHMED GLAUCOMA VALVE (AGV) SURGERY IN PATIENTS WITH NEOVASCULAR GLAUCOMA. A TOTAL OF 369 PATIENTS (N=369 EYES) WHO HAD UNDERGONE BGI SURGERY, WERE IMPLANTED WITH BGI (BG101-350 OR BG102-350; JOHNSON & JOHNSON VISION,CA, USA) (BGI GROUP; N=223 EYES) AND AGV SURGERY, WERE IMPLANTED WITH AGV (FP7; NEW WORLD MEDICAL,CA, USA) (AGV GROUP; N=146 EYES). EARLY-ONSET POSTOPERATIVE COMPLICATIONS (ONSET = 3 MONTHS) WERE: HYPHEMA (N=28), SHALLOW OR FLAT ANTERIOR CHAMBER (N=6), CHOROIDAL DETACHMENT (N=18), VITREOUS HEMORRHAGE (N=33), HYPOTONY MACULOPATHY (N=4), TUBE OBSTRUCTION (N=7), WOUND DEHISCENCE (N=2), REMOVAL OF THE TUBE SHUNT (N=1). LATE-ONSET POSTOPERATIVE COMPLICATIONS (ONSET > 3 MONTHS) WERE: HYPHEMA (N=7), VITREOUS HEMORRHAGE (N=16), HYPOTONY MACULOPATHY (N=3), ENDOPHTHALMITIS/BLEBITIS (N=4), RETINAL DETACHMENT (N=1), TUBE OBSTRUCTION (N=1), TUBE EROSION (N=14), REMOVAL OF THE TUBE SHUNT (N=7), SUPRACHOROIDAL HEMORRHAGE (N=1). AT THE FINAL FOLLOW-UP, VISUAL ACUITY WAS 1.6 ± 1.2 (LOGMAR) IN THE BGI GROUP. THE VISUAL ACUITY DETERIORATED (N=124 EYES), IN WHICH VISUAL ACUITY DECREASED TO NO LIGHT PERCEPTION (NLP) (N=27 EYES). INTERVENTIONS PERFORMED IN THE BGI GROUP INCLUDED: REMOVAL OF THE RIP CORD (N=6), LASER SUTURE LYSIS (N=1), NEEDLING (N=1), INTRAVITREAL INJECTION OF ANTI-VASCULAR ENDOTHELIAL GROWTH FACTOR THERAPY (ANTI-VEGF), (N=20), SUB-TENON¿S TRIAMCINOLONE ACETONIDE (N=3), ANTERIOR CHAMBER WASHING (N=1), ADDITIONAL SUTURE (N=5), PARS PLANA VITRECTOMY (N=15), PHACOEMULSIFICATION (N=3), ANTERIOR CHAMBER REFORMATION (N=5), TUBE LUMEN RELEASING (N=7), TUBE REVISION WITH PATCH GRAFT (N=3). A COPY OF THIS ARTICLE IS ATTACHED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    80763 UNK_GLAUCOMA SHUNT_BAERVELDT SHUNT IMPLANT, EYE VALVE KYF AMO MANUFACTURING NETHERLANDS UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention