BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAERVELDT GLAUCOMA IMPLANT (350)

    MDR report key: 12022758 · Received June 18, 2021

    Report

    Report Number
    9614546-2021-07240
    Event Type
    Injury
    Date Received
    June 18, 2021
    Report Date
    July 12, 2024
    Manufacturer
    AMO MANUFACTURING NETHERLANDS
    Product Code
    KYF
    PMA / PMN Number
    K905129
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: UPON FURTHER REVIEW ON JUN 14, 2024, IT WAS NOTED THAT SECTION D4 MODEL NUMBER AND CATALOG NUMBER WERE SUBMITTED AS BAERVELDT GLAUCOMA IMPLANT (350) AND 23030821, CONSECUTIVELY, ON THE INITIAL MDR, BUT SHOULD BE BG101350 AND 23030817. THEREFORE, IT IS CAPTURED IN THIS SUPPLEMENTAL REPORT. THE FOLLOWING FIELD HAS BEEN UPDATED ACCORDINGLY: SECTION D4: MODEL NUMBER: BG101350. SECTION D4: CATALOG NUMBER: 23030817. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    AGE/DATE OF BIRTH: MEAN AGE: 55.00 ± 14.35 YEARS. SEX/GENDER: 26 MALES AND 19 FEMALES. DATE OF EVENT: EXACT DATES NOT PROVIDED, ARTICLE ACCEPTANCE DATE IS OCTOBER 1, 2020. SERIAL NUMBER: UNKNOWN, INFORMATION NOT PROVIDED. EXPIRATION DATE: UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. UDI NUMBER: UDI NUMBER IS UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. IMPLANT DATE: UNKNOWN, INFORMATION NOT PROVIDED. EXPLANT DATE: NOT APPLICABLE, AS THERE IS NO INDICATION THAT THE DEVICE WAS EXPLANTED. PHONE NUMBER: (B)(6). THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE SERIAL NUMBER FOR THE 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. DEVICE MANUFACTURE DATE: UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. (B)(4). CITATION: WATANABE, S., HAMANAKA, T., SAKURAI, T., KOBAYASHI, K., ISHIDA, N., EBIHARA, N., EVALUATION OF THE OUTCOME OF LONG-TUBE SHUNT IMPLANT SURGERY IN UVEITIC GLAUCOMA PATIENTS BY ANALYZING THE BACKGROUND OF UVEITIS, (2021), INT OPHTHALMOL, 41:PP. 509¿517 ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    THE FOLLOWING ARTICLE WAS RECEIVED BASED ON A LITERATURE REVIEW: TITLE: EVALUATION OF THE OUTCOME OF LONG-TUBE SHUNT IMPLANT SURGERY IN UVEITIC GLAUCOMA PATIENTS BY ANALYZING THE BACKGROUND OF UVEITIS. A RETROSPECTIVE STUDY WAS DONE TO EVALUATE THE EFFICACY OF LONG-TUBE SHUNT SURGERY (LTSS) WITHOUT VALVE IN UVEITIC GLAUCOMA (UG) EYES. A TOTAL OF 45 EYES OF 41 JAPANESE UG PATIENTS UNDERWENT LTSS (N=21) OR LTSS COMBINED WITH TRABECULECTOMY (TLE) (N=24). THE TYPES OF LTSS PERFORMED WERE BAERVELDT 250 (N=16 EYES; JOHNSON & JOHNSON VISION), BAERVELDT 350 (UG GROUP: N=18 EYES; JOHNSON & JOHNSON VISION), AND DOUBLE-PLATE MOLTENO GLAUCOMA DRAINAGE DEVICE (N=11 EYES; MOLTENO OPHTHALMIC LTD). SEVEN (7) EYES WERE CLASSIFIED AS SURGICAL TREATMENT FAILURE DUE TO IOP OF MORE THAN 22 MMHG (N=5 EYES), AN INSUFFICIENT IOP DECREASE OF LESS THAN 20% (N=1 EYE), AND PLATE EXPOSURE (N=1 EYE). RECURRENCE OF IRITIS WAS OBSERVED IN 7 EYES AND CORNEAL EDEMA OCCURRED IN 4 EYES. CORNEAL TRANSPLANTATION WAS PERFORMED IN 2 OF THOSE 4 EYES WITH CORNEAL EDEMA AS INTERVENTION. IT IS NOT CLEAR IF THESE COMPLICATIONS OCCURRED IN THE EYES IMPLANTED WITH BAERVELDT 250, BAERVELDT 350 OR THE OTHER PRODUCT. THIS REPORT IS FOR THE BAERVELDT 350 DEVICE. A SEPARATE REPORT WILL BE SUBMITTED FOR THE BAERVELDT 250 DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    925307 BAERVELDT GLAUCOMA IMPLANT (350) IMPLANT, EYE VALVE KYF AMO MANUFACTURING NETHERLANDS BG101350

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention