BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS 1-PIECE

    MDR report key: 8384188 · Received March 1, 2019

    Report

    Report Number
    2648035-2019-00266
    Event Type
    Injury
    Date Received
    March 1, 2019
    Date of Event
    February 1, 2019
    Report Date
    November 9, 2020
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    HQL
    UDI-DI
    05050474531741
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 NR-0148919 AND CAPA-010215.

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS INDICATED THAT THE DEVICE IS NOT RETURNING ; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. A REVIEW OF THE DEVICE/LOT 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. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TECNIS MONOFOCAL INTRAOCULAR LENS (MODEL ZCB00 21.5 DIOPTER) WAS EXPLANTED FROM PATIENT¿S RIGHT EYE IN SECONDARY SURGICAL PROCEDURE BECAUSE OF PATIENT EXPERIENCING DECREASED VISUAL ACUITY AND MYOPIA. REPORTEDLY ANOTHER LENS WITH ZCB00 LOWER DIOPTER 20.0 WAS USED AS THE REPLACEMENT LENS. THERE WAS NO INCISION ENLARGEMENT, NO SUTURES, NO VITRECTOMY REQUIRED. PATIENT WAS DOING FINE, STABLE AT DISCHARGE. VISUAL ACUITY PRE-OP (PRE- INITIAL IMPLANT) (B)(6) 2018 (20/60 +2). VISUAL ACUITY POST-OP (POST- INITIAL IMPLANT) (B)(6) 2019 (20/150). VISUAL ACUITY POST-OP (POST-REPLACEMENT) (B)(6) 2019 (20/50+2). NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    176076 TECNIS 1-PIECE MONOFOCAL IOLS HQL JOHNSON & JOHNSON SURGICAL VISION, INC. ZCB00 05050474531741

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention