BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS 1 MULTIFOCAL

    MDR report key: 8706208 · Received June 17, 2019

    Report

    Report Number
    9614546-2019-00558
    Event Type
    Injury
    Date Received
    June 17, 2019
    Date of Event
    May 7, 2019
    Report Date
    November 12, 2020
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    MFK
    UDI-DI
    05050474560697
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    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 · 0

    THE REPORTED EVENT OF AN OBSTRUCTED LEAFLET COULD NOT BE CONFIRMED. THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE DEVICE HISTORY RECORD WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED AND THE PRODUCT MET ALL SPECIFICATIONS AT THE TIME OF COMMERCIALIZATION. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED; HOWEVER, INFORMATION FROM THE FIELD INDICATED THAT A SMALLER, 17MM, REGENT VALVE WAS USED TO COMPLETE THE PROCEDURE, WHICH IS POSSIBLE EVIDENCE OF INITIAL OVER-SIZING. PLEASE NOTE, PER THE INSTRUCTIONS FOR USE ARTMT100122074, REV A, "PROPER VALVE SIZE SELECTION IS CRUCIAL. DO NOT OVERSIZE THE VALVE. IF THE NATIVE ANNULUS MEASUREMENT FALLS BETWEEN TWO SJM REGENT¿ MECHANICAL HEART VALVE SIZES, USE THE SMALLER SIZE SJM REGENT¿ MECHANICAL HEART VALVE."

    Additional Manufacturer Narrative · 1

    (B)(4). ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A ZLB00 INTRAOCULAR LENS (IOL) WAS EXPLANTED IN ONE PIECE DUE TO MECHANICAL COMPLICATION. AN INCISION ENLARGEMENT WAS PERFORMED. ADDITIONAL INFORMATION RECEIVED REPORTED THAT PATIENT HAD SIGNIFICANT DIFFICULTY WITH BLURRY VISION. THE PATIENT HAD NO CONTRIBUTING MEDICAL HISTORY. THERE WAS NO VISUAL IMPROVEMENT NOTED WITH THE RECOMMENDED USE OF ARTIFICIAL TEARS OR WITH SPECTACLES. THE EXPLANTED IOL WAS REPLACED WITH A AAB00 IOL AND THE PATIENT IS HEALING WELL. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    496893 TECNIS 1 MULTIFOCAL MULTIFOCAL IOLS MFK JOHNSON & JOHNSON SURGICAL VISION, INC. ZLB00 05050474560697

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention