BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAERVELDT GLAUCOMA IMPLANT (350)

    MDR report key: 11980350 · Received June 10, 2021

    Report

    Report Number
    9614546-2021-07181
    Event Type
    Injury
    Date Received
    June 10, 2021
    Report Date
    June 10, 2021
    Manufacturer
    AMO MANUFACTURING NETHERLANDS
    Product Code
    KYF
    PMA / PMN Number
    K905129
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE OR DATE OF BIRTH: INCLUSION CRITERIA INCLUDED AGE (18¿75 YEARS). WEIGHT: INFORMATION UNKNOWN/ NOT PROVIDED. RACE: CAUCASIAN ORIGIN. DATE OF EVENT: EXACT DATES UNKNOWN/ NOT PROVIDED, ARTICLE ACCEPTED ON NOVEMBER 9TH, 2020. IMPLANT DATE: UNKNOWN/ NOT PROVIDED. EXPLANT DATE: NOT APPLICABLE, THERE IS NO INDICATION OF ANY EXPLANTED DEVICES. REPORTER TELEPHONE NUMBER: (B)(6). MANUFACTURER TELEPHONE NUMBER: (B)(4). THE GLAUCOMA IMPLANTS ARE NOT RETURNING FOR EVALUATION AS THEY REMAIN IMPLANTED. THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICES CANNOT BE COMPLETED. A REVIEW OF THE DEVICE HISTORY RECORD, LABELING, COMPLAINT TRENDING, AND RISK DOCUMENTATION FOR THIS DEVICE WILL BE PERFORMED. UPON COMPLETION OF THE REVIEW, IF THERE IS ANY FURTHER RELEVANT INFORMATION A SUPPLEMENTAL MEDWATCH WILL BE FILED. CITATION: ISLAMAJ, E., JORDAAN-KUIP, C. P., DE WAARD, P. W. T., VERMEER, K. A., AND LEMIJ, H. G. (2021). OCULAR MOTILITY CHANGES AND DIPLOPIA IN SUTURED VERSUS UNSUTURED IMPLANTATION OF THE BAERVELDT GLAUCOMA DEVICE. ACTA OPHTHALMOLOGICA. DOI: 10.1111/AOS.14707. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    THE FOLLOWING ARTICLE WAS RECEIVED BASED ON A LITERATURE REVIEW: OCULAR MOTILITY CHANGES AND DIPLOPIA IN SUTURED VERSUS UNSUTURED IMPLANTATION OF THE BAERVELDT GLAUCOMA DEVICE. A PROSPECTIVE COHORT STUDY WAS DONE TO INVESTIGATE THE EFFECT OF TWO SURGICAL TECHNIQUES IN PRIMARY BAERVELDT GLAUCOMA IMPLANT (BGI) SURGERY, THAT IS THE SUTURED TECHNIQUE AND THE UNSUTURED (FREE) PLATE TECHNIQUE, ON THE OCULAR MOTILITY AND PREVALENCE OF DIPLOPIA. THE BAERVELDT GLAUCOMA IMPLANT (BGI) (BG-101-350, ADVANCED MEDICAL OPTICS INC.) WAS PLACED IN ALL PATIENTS IN THE SUPEROTEMPORAL QUADRANT, WITH ITS WINGS SITTING UNDER THE LATERAL AND SUPERIOR RECTUS MUSCLES. IN TOTAL, 38 PATIENTS DEVELOPED DIPLOPIA AT SOME POINT DURING FOLLOW-UP. AT 1 YEAR FOLLOW-UP, THE FOLLOWING ADVERSE EVENTS WERE NOTED (N = NUMBER OF PATIENTS): FREE PLATE GROUP: DIPLOPIA (N=16), DUCTION CHANGE (N=34), STATISTICALLY SIGNIFICANT LOSS OF HORIZONTAL FUSION (N=36), STATISTICALLY SIGNIFICANT LOSS OF VERTICAL FUSION (N=11), MILD GLAUCOMATOUS VISUAL FIELD LOSS (N=14 IN PATIENTS WITH DIPLOPIA, 77% IN PATIENTS WITHOUT DIPLOPIA), HORIZONTAL CHANGE IN OCULAR ALIGNMENT IN THE EXODIRECTION (N=10), HORIZONTAL CHANGE IN OCULAR ALIGNMENT IN THE ESODIRECTION (N=6). SUTURED PLATE GROUP: DIPLOPIA (N=14), DUCTION CHANGE (N=18), STATISTICALLY SIGNIFICANT LOSS OF HORIZONTAL FUSION (N=23), STATISTICALLY SIGNIFICANT LOSS OF VERTICAL FUSION (N=15), MILD GLAUCOMATOUS VISUAL FIELD LOSS (N=12 IN PATIENTS WITH DIPLOPIA, 57% IN PATIENTS WITHOUT DIPLOPIA), HORIZONTAL CHANGE IN OCULAR ALIGNMENT IN THE EXODIRECTION (N=7), HORIZONTAL CHANGE IN OCULAR ALIGNMENT IN THE ESODIRECTION (N=3). IN THE TOTAL GROUP: CHANGE IN VERTICAL DIRECTION (N=18), HYPERDEVIATION IN THE OPERATED EYE (N=13). THERE ARE NO INDICATIONS IN THE ARTICLE OF ANY INTERVENTIONS PROVIDED. OTHER JNJ PRODUCTS WERE MENTIONED BUT NO COMPLAINTS WERE REPORTED AGAINST THEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    876564 BAERVELDT GLAUCOMA IMPLANT (350) IMPLANT, EYE VALVE KYF AMO MANUFACTURING NETHERLANDS BG101350

    Patients

    Seq Age Sex Outcome Treatment
    1 Other