BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK_GLAUCOMA SHUNT_BAERVELDT SHUNT

    MDR report key: 17195672 · Received June 23, 2023

    Report

    Report Number
    3012236936-2023-01544
    Event Type
    Injury
    Date Received
    June 23, 2023
    Report Date
    June 23, 2023
    Manufacturer
    AMO MANUFACTURING NETHERLANDS
    Product Code
    KYF
    PMA / PMN Number
    K955455
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION A2: MEAN AGE 34.0 ± 26.7 SECTION A3: 7 FEMALE AND 7 MALE PATIENTS SECTIONS A4, A5: INFORMATION UNKNOWN/NOT PROVIDED. SECTION B3: DATE OF EVENT: EXACT DATES NOT PROVIDED. ARTICLE ACCEPTANCE DATE IS MARCH 4, 2022. THE STUDY WAS CONDUCTED FOR SURGERIES PERFORMED BETWEEN (B)(6) 2016 AND (B)(6) 2018. SECTION D4: MODEL NUMBER: MODEL NUMBER IS UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. SECTION D4: CATALOG NUMBER: CATALOG NUMBER IS UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. SECTION D4: SERIAL NUMBER: UNKNOWN, INFORMATION NOT PROVIDED. SECTION D4: EXPIRATION DATE: UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. SECTION D4: UDI NUMBER: UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. SECTION D6A - IMPLANT DATE: UNKNOWN/ NOT PROVIDED SECTION D6B - EXPLANT DATE: N/A, DEVICE REMAINS IMPLANTED. SECTION H3 - OTHER (81): THE IMPLANT WAS NOT RETURNED FOR EVALUATION AS IT REMAINS IMPLANTED. THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE DEVICE HISTORY RECORD, COMPLAINT TRENDING, AND RISK DOCUMENTATION FOR THIS DEVICE WILL BE PERFORMED. UPON COMPLETION OF THE REVIEW AND POSSIBLE PRODUCT RETURN AND EVALUATION, IF THERE IS ANY FURTHER RELEVANT INFORMATION A SUPPLEMENTAL MEDWATCH WILL BE FILED. SECTION H4: DEVICE MANUFACTURE DATE: UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. SECTION H6 -HEALTH EFFECT - COMPONENT CODE 4756: TUBE CORNEAL TOUCH SECTION H6 -HEALTH EFFECT - CLINICAL CODE 4581: SHALLOWING OR COLLAPSING OF THE ANTERIOR CHAMBER SECTION H6 -HEALTH EFFECT - MEDICAL DEVICE PROBLEM CODE 3191: TUBE CORNEAL TOUCH CITATION: ALJALOUD, A. ALHILALI, S., EDWARD, D.P., AHMAD, K., MALIK, R.; PRELIMINARY SURGICAL OUTCOMES OF A TRIMMED-PLATE AUROLAB AQUEOUS DRAINAGE IMPLANT (AADI) IN EYES AT HIGH RISK OF HYPOTONY; (B)(6) 2022; CLINICAL OPHTHALMOLOGY 2022:16 1487¿1496 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: PRELIMINARY SURGICAL OUTCOMES OF A TRIMMED-PLATE AUROLAB AQUEOUS DRAINAGE IMPLANT (AADI) IN EYES AT HIGH RISK OF HYPOTONY A RETROSPECTIVE COHORT STUDY WAS DONE TO DESCRIBE THE TECHNIQUE OF TRIMMING THE 350 MM2 AADI GLAUCOMA SHUNT PLATE AND REPORT PRELIMINARY RESULTS THAT TEST THE HYPOTHESIS THAT THE IOP-LOWERING EFFICACY OF THE TRIMMED AADI GLAUCOMA SHUNT IS COMPARABLE TO THE BAERVELDT 250 MM2 GLAUCOMA DRAINAGE IMPLANT WITH A COMPARABLE SAFETY PROFILE TO THE STANDARD AADI IMPLANT. A TOTAL OF 69 EYES (N=69 EYES) WERE GROUPED INTO TRIMMED-PLATE AUROLAB AQUEOUS DRAINAGE DEVICE (AADI, AUROLAB, MADURAI, INDIA) (N=19 EYES); STANDARD AADI IMPLANT (N=36 EYES); AND BAERVELDT GLAUCOMA IMPLANT (BGI-250, ADVANCED MEDICAL OPTICS, INC., SANTA ANA, CA, USA) (N=14 EYES). SURGICAL TECHNIQUES FOR THE AADI AND TRIMMED AADI WERE SIMILAR TO THAT USED FOR THE BGI. SUTURES INCLUDED 6/0 OR 7/0 VICRYL SUTURES, 9/0 PROLENE OR 9/0 NYLON SUTURE, 9/0 NYLON MATTRESS SUTURE, 4/0 NYLON RIPCORD; AND FOR THE TRIMMED-PLATE AADI GROUP, THE PLATE WERE TRIMMED WITH CURVED STEVEN¿S SCISSORS. COMPLICATIONS INCLUDED IMPLANT FAILURE (N=2) BECAUSE OF UNCONTROLLED IOP IN THE BGI-250 GROUP. OTHER EVENTS WERE TUBE EROSION (N=2), TUBE OCCLUSION (N=1), TUBE CORNEAL TOUCH (N=1), SHALLOW ANTERIOR CHAMBER (AC) (N=1); ENDOPHTHALMITIS (N=1) THAT WAS SECONDARY TO TUBE EROSION THAT WAS MANAGED WITH PARS PLANA VITRECTOMY (PPV) AND REMOVAL OF THE TUBE; EARLY HYPOTONY (N=1) THAT WAS MANAGED BY ANTERIOR CHAMBER (AC) REFORMATION WHICH RESOLVED THE HYPOTONY. THERE WERE NO FURTHER INTERVENTIONS REPORTED. OTHER JNJ PRODUCTS WERE MENTIONED BUT NO COMPLAINTS WERE REPORTED AGAINST THEM. NO FURTHER DETAILS WERE PROVIDED. A COPY OF THE ARTICLE IS PROVIDED WITH THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1900110 UNK_GLAUCOMA SHUNT_BAERVELDT SHUNT IMPLANT, EYE VALVE KYF AMO MANUFACTURING NETHERLANDS UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention