BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS ITEC PRELOADED 1-PIECE IOL

    MDR report key: 8283831 · Received January 28, 2019

    Report

    Report Number
    2648035-2019-00124
    Event Type
    Injury
    Date Received
    January 28, 2019
    Date of Event
    December 10, 2018
    Report Date
    November 6, 2020
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    HQL
    UDI-DI
    05050474558250
    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-(B)(4) 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 AND JOHNSON SURGICAL VISION HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT WAS SCHEDULED FOR AN INTRAOCULAR EXPLANT IN SECONDARY PROCEDURE FROM PATIENT¿S LEFT EYE ON (B)(6) 2019 BECAUSE OF PATIENT EXPERIENCING PSEUDOPHAKIA, MYOPIA, ASTIGMATISM WHICH IMPACTED PATIENT WITH DECREASED VISUAL ACUITY. ADDITIONAL INFORMATION WAS RECEIVED, AND IT WAS LEARNT THAT THE LENS WAS EXPLANTED ON (B)(6) 2019. THERE WAS NO INCISION ENLARGEMENT, NO SUTURES, NO VITRECTOMY REQUIRED. PATIENT WAS DOING FINE WHEN DISCHARGED. VISUAL ACUITY PRE-OP (PRE-INITIAL IMPLANT): (B)(6) 2018 (20/70 -2); VISUAL ACUITY POST-OP (POST-INITIAL IMPLANT): (B)(6) 2019 (20/50 +2); VISUAL ACUITY POST-OP (POST-REPLACEMENT): (B)(6) 2019 (20/80 +2). NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76520 TECNIS ITEC PRELOADED 1-PIECE IOL MONOFOCAL IOLS HQL JOHNSON & JOHNSON SURGICAL VISION, INC. PCB00 05050474558250

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention