BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS

    MDR report key: 8259707 · Received January 18, 2019

    Report

    Report Number
    3011852734-2019-00019
    Event Type
    Injury
    Date Received
    January 18, 2019
    Report Date
    November 6, 2020
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    HQL
    UDI-DI
    05050474552098
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: THROUGH FOLLOW UP WITH THE DOCTOR, IT WAS LEARNED THAT THERE IS NO CHANGE IN THE PATIENT'S VISUAL ACUITY AND SHE REMAINS AT +4.0. THE DOCTOR DECIDED TO GIVE THE PATIENT CONTACT LENSES AND FOR THE TIME BEING, THERE ARE NO PLANS TO EXPLANT THE LENS. THE DOCTOR WILL NOTIFY JOHNSON & JOHNSON IF THERE ARE ANY MORE CHANGES OR IF THEY DECIDE TO EXPLANT THE LENS. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    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

    DATE OF EVENT: UNKNOWN, NOT PROVIDED. IF EXPLANTED; GIVE DATE: N/A (NOT APPLICABLE). TO DATE, THE LENS REMAINS IMPLANTED. THE INTRAOCULAR LENS (IOL) IS NOT RETURNING FOR EVALUATION AS IT REMAINS IMPLANTED; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE 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. (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 PATIENT HAD 5 DIOPTER HYPEROPIC MISS AFTER THE IMPLANTATION OF MODEL ZCT150 +17.50 DIOPTER TORIC IOL (INTRAOCULAR LENS) IN HER LEFT EYE (OS). THE IOL MASTER PREDICTED A PLANO RESULT WITH THIS LENS AND THE LENS APPEARS FINE AT POST-OP AS IT IS NOT SITTING POSTERIOR. THROUGH FOLLOW-UP, THERE WERE NO OTHER VISUAL ISSUES REPORTED OTHER THAN THE PATIENT BEING A +4.00 POST-OP AND PATIENT BEING UNHAPPY WITH HER VISUAL ACUITY. IT WAS ALSO INDICATED THAT THE PATIENT HAS PSEUDOEXFOLIATION (PXS) SYNDROME IN HER RIGHT EYE (OD). THE DOCTOR HAS NOT YET MADE THE DECISION WHETHER IT WOULD BE BEST TO EXPLANT THE LENS OR TO DO A PIGGYBACK IOL IN THE SETTING OF PXS. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54059 TECNIS TORIC IOLS HQL JOHNSON & JOHNSON SURGICAL VISION, INC. ZCT150 05050474552098

    Patients

    Seq Age Sex Outcome Treatment
    1 Other