BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS ITEC PRELOADED 1-PIECE IOL

    MDR report key: 10857415 · Received November 17, 2020

    Report

    Report Number
    2648035-2020-00862
    Event Type
    Malfunction
    Date Received
    November 17, 2020
    Date of Event
    October 20, 2020
    Report Date
    November 17, 2020
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    HQL
    UDI-DI
    05050474558267
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IF EXPLANTED, GIVE DATE: NOT APPLICABLE, REMAINS IMPLANTED IN THE EYE. DEVICE EVALUATION: LENS REMAINS IMPLANTED. SINCE PRODUCT AND PARTICLE ARE NOT AVAILABLE, THE COMPLAINT ISSUE REPORTED COULD NOT BE VERIFIED. PRODUCT DEFICIENCY COULD NOT BE DETERMINED. MANUFACTURING RECORDS REVIEW: THE MANUFACTURING RECORDS FOR THE DEVICE WERE REVIEWED. THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATION. A SEARCH IN COMPLAINT SYSTEM REVEALED ONLY ONE ADDITIONAL COMPLAINT FOLDER FOR THIS PRODUCTION ORDER (PO) NUMBER BUT PRODUCT DEFICIENCY NOT IDENTIFIED. CONCLUSION: AS A RESULT OF THE INVESTIGATION THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY AND THE REPORTED ISSUE COULD NOT BE VERIFIED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PIECE OF PLASTIC CAME OUT FROM THE INJECTOR AND WAS IMPLANTED IN THE EYE WITH THE LENS. THE LENS WAS FULLY INSERTED. THERE WAS A DELAY OF 1 MINUTE. THERE WAS NO INCISION ENLARGEMENT OR VITRECTOMY. THE PATIENT HAS FULLY RECOVERED. THE EVENT WAS OBSERVED DURING IMPLANTATION. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1319671 TECNIS ITEC PRELOADED 1-PIECE IOL MONOFOCAL IOLS HQL JOHNSON & JOHNSON SURGICAL VISION, INC. PCB00 05050474558267

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR