BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK_GLAUCOMA SHUNT_BAERVELDT SHUNT

    MDR report key: 24077496 · Received January 15, 2026

    Report

    Report Number
    3012236936-2026-000018
    Event Type
    Injury
    Date Received
    January 15, 2026
    Report Date
    January 15, 2026
    Manufacturer
    AMO MANUFACTURING NETHERLANDS
    Product Code
    KYF
    PMA / PMN Number
    K955455
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION A4: WEIGHT: UNKNOWN/NOT PROVIDED. SECTION A5: ETHNICITY: UNKNOWN/NOT PROVIDED. SECTION B3: DATE OF EVENT: EXACT DATES NOT PROVIDED; ARTICLE ACCEPTANCE DATE IS FEB 2, 2023. SECTION D4: MODEL NUMBER: THE EXACT MODEL IS UNKNOWN/NOT PROVIDED; ONLY PROVIDED AS BGI 350. SECTION D4: CATALOG NUMBER: UNKNOWN/NOT PROVIDED. SECTION D4: SERIAL NUMBER: UNKNOWN/NOT PROVIDED. SECTION D4: EXPIRATION DATE: UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. SECTION D4: UNIQUE IDENTIFIER (UDI) NUMBER: UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. SECTION D6A. IF IMPLANTED, GIVE DATE: UNKNOWN, INFORMATION NOT PROVIDED. SECTION D6B. IF EXPLANTED, GIVE DATE: UNKNOWN, INFORMATION NOT PROVIDED. SECTION H3: THE DEVICE WAS NOT RETURNED FOR EVALUATION AND THE SERIAL NUMBER FOR THIS DEVICE IS UNKNOWN/NOT PROVIDED; THEREFORE, NO FURTHER PRODUCT INVESTIGATION CAN BE PERFORMED. SHOULD ANY FURTHER RELEVANT INFORMATION BECOME AVAILABLE A SUPPLEMENTAL MEDWATCH WILL BE FILED. SECTION H4: DEVICE MANUFACTURE DATE: UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. CITATION: WONG JC, SAVSANI E, MAHMOUDZADEH R, SALABATI M, RAZEGHINEJAD R, LEE D, SHUKLA AG, MYERS JS, PRO MJ, MOSTER MR, DUNN JP, KOLOMEYER NN (2024) GLAUCOMA SURGICAL OUTCOMES IN PATIENTS WITH A HISTORY OF SCLERITIS. OCULAR IMMUNOLOGY AND INFLAMMATION, 32(6):987-993. DOI: 10.1080/09273948.2023.2177678. AN ATTEMPT HAS BEEN MADE TO OBTAIN MISSING INFORMATION; HOWEVER, THE INFORMATION HAS NOT BEEN PROVIDED. 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: GLAUCOMA SURGICAL OUTCOMES IN PATIENTS WITH A HISTORY OF SCLERITIS. A RETROSPECTIVE CASE SERIES WAS DONE TO ASSESS THE OUTCOMES OF GLAUCOMA SURGERY IN PATIENTS WITH A HISTORY OF SCLERITIS AT A TERTIARY MEDICAL CENTER. A TOTAL OF 28 EYES OF 25 PATIENTS WITH GLAUCOMA AND SCLERITIS/SCLERAL THINNING UNDERWENT SURGICAL INTERVENTION FOR GLAUCOMA. TWELVE PATIENTS WERE IMPLANTED WITH EITHER AHMED FP7 OR FP8 (AGV) (NEWWORLD MEDICAL) OR BAERVELDT GLAUCOMA IMPLANT 250 OR 350 (BGI) (JOHNSON & JOHNSON). ADDITIONAL BASELINE CLINICAL CHARACTERISTICS OF THE 28 EYES WERE REPORTED THAT INCLUDE 6 EYES THAT HAD PRIOR GLAUCOMA SURGERY WITH A TUBE SHUNT (AHMED FP7 OR FP8 OR BAERVELDT 250 OR 350). ONE OF THE 6 EYES UNDERWENT TUBE EXPLANTATION BUT IT IS NOT CLEAR IF THIS OCCURRED WITH BAERVELDT OR THE OTHER NON-JNJ DEVICE. IT WAS REPORTED THAT 7 EYES WERE CONSIDERED AS SURGICAL FAILURE. SURGICAL FAILURE WAS DEFINED AS THE NEED FOR REOPERATION FOR FURTHER GLAUCOMA CONTROL, IOP REDUCTION <20% BELOW BASELINE ON TWO CONSECUTIVE VISITS, IOP < 6 MMHG ON 2 CONSECUTIVE VISITS, OR IOP >18 MMHG ON 2 CONSECUTIVE VISITS, AFTER 3 MONTHS POST-OPERATIVELY. ADDITIONALLY, THERE WERE 3 EYES IMPLANTED WITH BGI WHICH WERE SPECIFIED IN A TABLE (TABLE 5): 1. ONE EYE IMPLANTED WITH BGI 350 HAD AN IOP >18MMHG 2. ONE EYE IMPLANTED WITH BGI 350 UNDERWENT REOPERATION (EXPLANT) DUE TO EXPOSURE AND WAS REPLACED WITH BGI 250 3. ONE EYE IMPLANTED WITH BGI 250 HAD AN IOP <6MMHG A COPY OF THE ARTICLE IS PROVIDED WITH THIS REPORT. THIS REPORT DOCUMENTS THE ISSUES REPORTED FOR A 71-YEAR-OLD FEMALE PATIENT IMPLANTED WITH DEVICE BGI 350. SEPARATE REPORTS WILL BE SUBMITTED FOR THE OTHER PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    140146 UNK_GLAUCOMA SHUNT_BAERVELDT SHUNT IMPLANT, EYE VALVE KYF AMO MANUFACTURING NETHERLANDS UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Female Required Intervention