BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK_GLAUCOMA SHUNT_BAERVELDT SHUNT

    MDR report key: 24032166 · Received January 12, 2026

    Report

    Report Number
    3012236936-2026-000001
    Event Type
    Injury
    Date Received
    January 12, 2026
    Report Date
    January 10, 2026
    Manufacturer
    AMO MANUFACTURING NETHERLANDS
    Product Code
    KYF
    PMA / PMN Number
    K955455
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION A2 PATIENT AGE: YEARS OF 43 PATIENTS FOR THE TUBE LIGATURE (TL) GROUP IS 61.18 (17.80%) AND OF 29 PATIENT'S FOR THE TUBE LIGATURE PLUS RIP CORD STENT IS 63.17 (18.61) SECTION A3A PATIENT SEX: # PATIENTS (%TOTAL): FEMALE 25 (58.1%) AND MALE 18 (41.9%) FOR THE TL GROUP AND FEMALE 11 (37.9%) AND MALE 18 (62.1%) FOR THE TLS GROUP. SECTION A3B, A4, AND A5: UNKNOWN/ INFORMATION WAS NOT PROVIDED. SECTION B3: DATE OF EVENT: 31 JANUARY 2025 (DATE ARTICLE WAS ACCEPTED). SECTION D4 MODEL NUMBER: UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED; ONLY PROVIDED AS BAERVELDT-350. SECTION D4 CATALOG NUMBER: UNKNOWN, AS DEVICE SERIAL NUMBER WAS NOT PROVIDED. SECTION D4 DEVICE SERIAL NUMBER: UNKNOWN, AS INFORMATION WAS NOT PROVIDED. SECTION D4 DEVICE EXPIRATION DATE: UNKNOWN, AS DEVICE SERIAL NUMBER WAS NOT PROVIDED. SECTION D4 UDI NUMBER: UNKNOWN, AS DEVICE SERIAL NUMBER WAS NOT PROVIDED. . SECTION H3: THE DEVICE WAS NOT RETURNED FOR EVALUATION. 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. CITATION: SEGURA-DUCH G, OLIVER-GUTIERREZ D, DUCH S, ET AL. IMPACT OF THE RESTRICTIVE TECHNIQUE ON OUTCOMES IN BAERVELDT-350 IMPLANT SURGERY. BMJ OPEN OPHTHALMOLOGY 2025;10:E001879. DOI:10.1136/ BMJOPHTH-2024-001879. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    THE FOLLOWING ARTICLE WAS RECEIVED BASED ON A LITERATURE REVIEW: ARTICLE: IMPACT OF THE RESTRICTIVE TECHNIQUE ON OUTCOMES IN BAERVELDT-350 IMPLANT SURGERY. A RETROSPECTIVE CONSECUTIVE CASE-SERIES OBSERVATIONAL STUDY WAS DONE TO COMPARE TUBE LIGATURE (TL) ALONE TO TL PLUS RIP CORD STENT (TLS) ON THE EFFICACY OF THE BAERVELDT 350. A TOTAL OF 72 EYES WITH GLAUCOMA UNDERWENT BAERVELDT 350 (BGI) IMPLANT SURGERY (BG101-350; ABBOTT MEDICAL OPTICS) AND WERE DIVIDED INTO TWO GROUPS: 43 EYES IN THE TL GROUP BUT ONLY 28 EYES COMPLETED THE STUDY WHILE 29 EYES IN THE TLS GROUP BUT ONLY 15 EYES COMPLETED THE STUDY. A TOTAL OF 29 EYES UNDERWENT BAERVELDT 350 (BGI) IMPLANT SURGERY WITH A 3/0 PROLENE STENT INSERTED INTO THE LUMEN PRIOR TO THE 6¿7/0 LIGATURE (OFF-LABEL). AFTER THE FIRST POSTOPERATIVE YEAR, ACROSS ALL SURGICAL CASES, 17.91% OF CASES WERE CONSIDERED A FAILURE. FAILURE CRITERIA WERE INTRAOCULAR PRESSURE (IOP) OVER 21 MM HG, LESS THAN 20% IOP REDUCTION (IOPR), SUSTAINED IOP UNDER 6 MM HG IN TWO CONSECUTIVE VISITS, LOSS OF LIGHT PERCEPTION, NEED FOR ADDITIONAL GLAUCOMA SURGERY OR IMPLANT REMOVAL. IN THE TL GROUP, COMPLICATIONS REPORTED INCLUDE THE FOLLOWING: TRANSIENT SYMPTOMATIC HYPOTONY (N=7 EYES) CHOROIDAL EFFUSION (N=5 EYES) HYPHEMA (N=5 EYES) TRANSIENT DIPLOPIA (N=4 EYES) AQUEOUS LEAK (N=4 EYES) CORNEAL OEDEMA (N=3 EYES) FLAT ANTERIOR CHAMBER (N=2 EYES) TUBE OCCLUSION (YAG* LASER IRIDOTOMY REQUIRED) (N=2 EYES) MALIGNANT GLAUCOMA (N=1 EYE) TUBE REPOSITIONING (N=1 EYE) TUBE REMOVAL (N=1 EYE) TUBE OCCLUSION (PARS PLANA VITRECTOMY REQUIRED) (N=1 EYE) WOUND DEHISCENCE (N=1 EYE) VITREOUS HAEMORRHAGE (N=1 EYE) CORNEAL GRAFT REJECTION (N=1 EYE) IMPLANT REMOVAL (CHRONIC HYPOTONY) (N=1 EYE) ENDOPHTHALMITIS (N=1 EYE) IN THE TLS GROUP, COMPLICATIONS REPORTED INCLUDE THE FOLLOWING: TRANSIENT SYMPTOMATIC HYPOTONY (N=1 EYE) CHOROIDAL EFFUSION (N=1 EYE) HYPHEMA (N=1 EYE) TUBE REPOSITIONING (N=1 EYE) ACUTE ANGLE-CLOSURE GLAUCOMA (N=1 EYE) CHOROIDAL HAEMORRHAGE (N=2 EYES) ENDOPHTHALMITIS (N=1 EYE) A COPY OF THE ARTICLE WAS ATTACHED TO THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    92900 UNK_GLAUCOMA SHUNT_BAERVELDT SHUNT IMPLANT, EYE VALVE KYF AMO MANUFACTURING NETHERLANDS UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention