BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAERVELDT SHUNT

    MDR report key: 23975332 · Received January 6, 2026

    Report

    Report Number
    3012236936-2026-000002
    Event Type
    Injury
    Date Received
    January 6, 2026
    Report Date
    February 3, 2026
    Manufacturer
    AMO MANUFACTURING NETHERLANDS
    Product Code
    KYF
    PMA / PMN Number
    K905129
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION A2: MEAN AGE 59 ± 17. SECTION A3: 28 (37%) FEMALE AND 48 MALE (63%) PATIENTS. SECTIONS A4, A5: PER EU REGULATION 2016/679 (GENERAL DATA PROTECTION REGULATION), PATIENT IDENTIFIERS WERE NOT COLLECTED OR RECORDED AND THEREFORE ARE NOT AVAILABLE. SECTION B3: DATE OF EVENT: EXACT DATES NOT PROVIDED. ARTICLE ACCEPTANCE DATE WAS THE 27TH JUNE 2024. 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 D6A: IMPLANT DATE: UNKNOWN/NOT PROVIDED. SECTION D6B: EXPLANT DATE: N/A - DEVICE REMAINS IMPLANTED. SECTION H3: THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE SERIAL NUMBER FOR THIS DEVICE IS NOT AVAILABLE; THEREFORE, NO FURTHER INVESTIGATION CAN BE COMPLETED. IF THERE IS ANY FURTHER RELEVANT INFORMATION RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE FILED. SECTION H4: DEVICE MANUFACTURE DATE: UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. CITATION: GIZZI, C., RAI, P., BARTON, K., (2024). AQUEOUS SHUNT EXPOSURE REPAIR: OUTCOMES AND RISK FACTORS FOR RECURRENCE. THE ROYAL COLLEGE OF OPHTHALMOLOGISTS, 38:3065¿3071; HTTPS://DOI.ORG/10.1038/S41433-024-03219-6. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: AFTER FURTHER REVIEW, IT WAS DETERMINED THAT CODING UPDATES WERE REQUIRED. CODES REMOVED: 4466 - EYE INFECTIONS 2137 - BLURRED VISION CODES ADDED: 4625 - ADDITIONAL SURGERY 4627 - DEVICE EXPLANTATION 4468 - INTRAOCULAR PRESSURE DECREASED 2138 - VISUAL IMPAIRMENT 1845 - EYE INJURY 3191 - APPROPRIATE TERM/CODE NOT AVAILABLE FOR UNSPECIFIED ISSUE. 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 LITERATURE REVIEW. ARTICLE: AQUEOUS SHUNT EXPOSURE REPAIR: OUTCOMES AND RISK FACTORS FOR RECURRENCE. A RETROSPECTIVE INTERVENTIONAL CASE SERIES WAS DONE TO INVESTIGATE THE OUTCOMES OF AQUEOUS SHUNT EXPOSURE REPAIR AND TO IDENTIFY RISK FACTORS FOR RECURRENT EXPOSURE AFTER SURGICAL REPAIR. A TOTAL OF 76 PATIENTS INCLUDED IN THE STUDY WERE IMPLANTED WITH EITHER THE BGI-101-350 (N=61 PATIENTS; JOHNSON & JOHNSON VISION, SANTA ANA), BGI-103¿250 (N=7 PATIENTS; JOHNSON & JOHNSON VISION), AGV (N=3 EYES), MOLTENO (N=1 EYE), AND 4 EYES WERE IMPLANTED WITH AN UNSPECIFIED GLAUCOMA IMPLANT. THE VAST MAJORITY OF THE IMPLANTS (N=70 PATIENTS) WERE OCCLUDED WITH A RIP-CORD (OFF-LABEL), FREQUENTLY COMBINED WITH AN EXTERNAL LIGATURE, EITHER NYLON OR VICRYL. ALL PATIENTS UNDERWENT REPAIR OF AN EXPOSED AQUEOUS SHUNT (N=73 TUBE EXPOSURE; N=1 PLATE EXPOSURE; N=1 PATCH EXPOSURE; AND N=1 STENT EXPOSURE). IT WAS REPORTED THAT 9 PATIENTS UNDERWENT REPOSITIONING OF THE TUBE: 8 IN THE ANTERIOR CHAMBER AND 1 IN THE SULCUS. IN 9 PATIENTS, THE TUBE WAS EVENTUALLY REMOVED: IN 4 CASES FOR LACK OF ADEQUATE TISSUE COVER, IN 2 CASES FOR ACCIDENTAL TUBE AMPUTATION DURING REVISION, IN 2 CASES FOR PLATE EXPOSURE AND IN 1 CASE FOR PERSISTENT HYPOTONY. FURTHERMORE, 2 PATIENTS HAD INFECTION-RELATED COMPLICATIONS: ONE TUBE EXPOSURE WITH TUBE RELATED ENDOPHTHALMITIS TREATED MEDICALLY BEFORE EXPOSURE REPAIR AND ONE HAD A SUSPECTED TUBE RELATED ENDOPHTHALMITIS AFTER THE SECOND TUBE EXPOSURE REPAIR. ONE CASE DEVELOPED CORNEAL DECOMPENSATION FOR FLAT ANTERIOR CHAMBER (AC) WITH LOSS OF LP AT LAST FOLLOW-UP. AFTER EXPOSURE REPAIR, 4 PATIENTS HAD INTRAOCULAR PRESSURE (IOP) HIGHER THAN 21 AND UNDERWENT FURTHER GLAUCOMA SURGERY. FINALLY, THERE WERE 23 PATIENTS WHO DEVELOPED FURTHER EXPOSURE REQUIRING SURGICAL REPAIR. IT IS UNCLEAR IF THE COMPLICATIONS OCCURRED IN THE EYES IMPLANTED WITH THE BGI-101-350 AND BGI-103¿250 DEVICE, OR THE NON-JNJ DEVICE. CITATION: GIZZI, C., RAI, P., BARTON, K., (2024). AQUEOUS SHUNT EXPOSURE REPAIR: OUTCOMES AND RISK FACTORS FOR RECURRENCE. THE ROYAL COLLEGE OF OPHTHALMOLOGISTS, 38:3065¿3071; HTTPS://DOI.ORG/10.1038/S41433-024-03219-6. A COPY OF THE ARTICLE IS PROVIDED WITH THIS REPORT. THIS REPORT IS FOR BGI-103¿250 . A SEPARATE REPORT IS BEING SUBMITTED FOR BGI-101-350 .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    33740 BAERVELDT SHUNT IMPLANT, EYE VALVE KYF AMO MANUFACTURING NETHERLANDS BG103-250 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention