BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAERVELDT SHUNT

    MDR report key: 8963534 · Received September 5, 2019

    Report

    Report Number
    9614546-2019-00816
    Event Type
    Injury
    Date Received
    September 5, 2019
    Report Date
    November 10, 2020
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    KYF
    PMA / PMN Number
    K955455
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS CORRECTION MDR IS BEING SUBMITTED TO ADDRESS INACCURATE INFORMATION IN SECTION F ON THE XML VERSION OF THE PREVIOUS SUBMISSION CAUSED BY A SOFTWARE GLITCH IN THE TRANSMISSION PROCESS. THE INTERNAL NON-CONFORMANCE NUMBERS FOR THIS SOFTWARE ISSUE ARE (B)(4), AND CAPA-010215.

    Additional Manufacturer Narrative · 1

    AGES/DATE(S) OF BIRTH: UNKNOWN, NOT PROVIDED. GENDERS/SEX(ES): UNKNOWN, NOT PROVIDED. DATE(S) OF EVENT: UNKNOWN, NOT PROVIDED. SERIAL #''S: UNKNOWN, NOT PROVIDED. UDI #: UNKNOWN AS THE SERIAL NUMBERS WERE NOT PROVIDED. IF IMPLANTED; IF EXPLANTED; GIVE DATES: UNKNOWN, NOT PROVIDED. THE DEVICES WERE NOT RETURNED FOR ANALYSIS. THE SERIAL NUMBERS FOR THE DEVICES WERE 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 DATES: UNKNOWN, INFORMATION NOT PROVIDED. (B)(4). ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    ARTICLE: DIPLOPIA IN MEDICALLY AND SURGICALLY TREATED PATIENTS WITH GLAUCOMA. OPHTHALMOLOGY 2017;124:257-262 © 2016 BY THE AMERICAN ACADEMY OF OPHTHALMOLOGY. AUTHORS: PHILIP Y. SUN, MS, DAVID A. LESKE, MS, JONATHAN M. HOLMES, BM, BCH, CHERYL L. KHANNA, MD. PURPOSE: TO REPORT THE PREVALENCE, TYPE, AND CAUSE OF DIPLOPIA IN MEDICALLY AND SURGICALLY TREATED PATIENTS WITH GLAUCOMA. DESIGN: COHORT STUDY. PARTICIPANTS: A TOTAL OF 195 ADULT PATIENTS WITH GLAUCOMA TREATED IN A GLAUCOMA REFERRAL PRACTICE. METHODS: A TOTAL OF 195 ADULT PATIENTS WITH GLAUCOMA WHO HAD UNDERGONE SURGICAL OR MEDICAL MANAGEMENT WERE PROSPECTIVELY ENROLLED. FORTY-SEVEN PATIENTS HAD UNDERGONE GLAUCOMA DRAINAGE DEVICE (GDD) SURGERY (BAERVELDT 350, BAERVELDT 250[ABBOTT MEDICAL OPTICS, (B)(6)], OR AHMED FP7 [NEW WORLD MEDICAL INC, (B)(6)]), 61 PATIENTS HAD UNDERGONE TRABECULECTOMY, AND 87 PATIENTS WERE MEDICALLY TREATED. ALL PATIENTS COMPLETED THE DIPLOPIA QUESTIONNAIRE TO ASSESS DIPLOPIA. WE DEFINED THE PRESENCE OF DIPLOPIA AS ¿SOMETIMES,¿ ¿OFTEN,¿ OR ¿ALWAYS¿ IN DISTANCE STRAIGHT AHEAD OR READING POSITIONS ON THE DIPLOPIA QUESTIONNAIRE. A CHART REVIEW WAS PERFORMED JOINTLY BY A STRABISMUS SPECIALIST AND A GLAUCOMA SUBSPECIALIST TO CHARACTERIZE THE TYPE AND CAUSE OF THE DIPLOPIA. MAIN OUTCOME MEASURES: FREQUENCY, TYPE, AND CAUSE OF DIPLOPIA. RESULTS: DIPLOPIA WAS REPORTED IN 41 OF 195 MEDICALLY AND SURGICALLY TREATED PATIENTS (21%) WITH GLAUCOMA. BINOCULAR DIPLOPIA DUE TO THE GLAUCOMA PROCEDURE WAS PRESENT IN 11 OF 47 PATIENTS (23%) AFTER GDD (95% CONFIDENCE INTERVAL, 12-38), WHICH WAS SIGNIFICANTLY GREATER THAN IN PATIENTS AFTER TRABECULECTOMY (2/61 [3%]; 95% CONFIDENCE INTERVAL, 0.4-11; P = 0.002). THE MOST COMMON TYPE OF STRABISMUS ASSOCIATED WITH BINOCULAR DIPLOPIA DUE TO GLAUCOMA SURGERY WAS HYPERTROPIA (10/11 GDD CASES, 2/2 TRABECULECTOMY CASES). MONOCULAR DIPLOPIA WAS FOUND IN A SIMILAR PROPORTION OF MEDICALLY TREATED, POST-TRABECULECTOMY, AND POST-GDD CASES (4/87 [5%], 4/61 [7%], AND 2/47 [4%], RESPECTIVELY). BINOCULAR DIPLOPIA NOT DUE TO SURGERY WAS FOUND IN SIMILAR PROPORTIONS OF GDD, TRABECULECTOMY, AND MEDICALLY TREATED CASES (3/47 [6%], 5/61 [8%], AND 10/87 [11%], RESPECTIVELY). CONCLUSIONS: DIPLOPIA MAY BE UNDER-RECOGNIZED IN MEDICALLY AND SURGICALLY TREATED PATIENTS WITH GLAUCOMA, AND STANDARDIZATION OF ASCERTAINING PATIENT SYMPTOMS USING THE DIPLOPIA QUESTIONNAIRE MAY BE USEFUL IN THESE PATIENTS. DIPLOPIA WAS MORE COMMONLY SEEN AFTER GDD THAN TRABECULECTOMY, TYPICALLY A NONCOMITANT RESTRICTIVE HYPERTROPIA. THE PREVALENCE OF MONOCULAR DIPLOPIA AND BINOCULAR DIPLOPIA UNRELATED TO GLAUCOMA SURGERY WAS SIMILAR AMONG MEDICAL AND SURGICAL GROUPS. IT IS IMPORTANT TO COUNSEL PATIENTS ON THE HIGHER OCCURRENCE OF DIPLOPIA ASSOCIATED WITH GDD SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    760171 BAERVELDT SHUNT SURGICAL ADJUNCTS KYF JOHNSON & JOHNSON SURGICAL VISION, INC. BG103-250

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention