BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS SYMFONY TORIC

    MDR report key: 8845948 · Received July 31, 2019

    Report

    Report Number
    3011852734-2019-00160
    Event Type
    Injury
    Date Received
    July 31, 2019
    Date of Event
    April 2, 2019
    Report Date
    November 12, 2020
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    POE
    UDI-DI
    05050474605695
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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

    IF EXPLANTED, GIVE DATE: THE LENS REMAINS IMPLANTED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER IMPLANTATION OF THE ZXT225 INTRAOCULAR LENS (IOL) IN THE PATIENTS RIGHT EYE AND THE REMOVAL OF THE BANDAGES, THE PATIENT COMPLAINED OF BLURRY VISION AT ALL DISTANCES AT ALL TIMES EXCEPT WHEN ILLUMINATED BY BRIGHT WHITE LED LIGHT OR FROM BRIGHT SUNLIGHT OUTDOORS. THIS PROBLEM DID NOT EXIST WITH THE PATIENTS NATURAL LENS. THE PATIENT ALSO REPORTED NOTABLE PHOTIC EFFECTS OF NIGHT VISION MARRED BY EXTREME START-BURSTS EMANATING FROM ALL LIGHT SOURCES AND A BLUISH CAST TO DAYLIGHT SCENES. NO SURGERY RELATED ISSUES HAVE BEEN UNCOVERED IN SUBSEQUENT FOLLOW-UP EXAMS. ADDITIONAL INFORMATION RECEIVED REPORTED THE SYMPTOMS HAVE SIGNIFICANTLY AFFECTED HIS ABILITY TO PERFORM DAILY TASKS SUCH AS DRIVING AT NIGHT. THE SUBJECT IF THERE WERE POTENTIALLY ANY ISSUES WITH THE MANUFACTURING OF THE IOL. THE SUBJECT WAS INFORMED THAT, UPON REVIEW OF THE COMPLAINT IOL, IT WAS DETERMINED THE IOL WAS MANUFACTURED WITHIN SPECIFICATIONS. NO ADDITIONAL INFORMATION WAS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    640021 TECNIS SYMFONY TORIC MULTIFOCAL IOLS POE JOHNSON & JOHNSON SURGICAL VISION, INC. ZXT225 05050474605695

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Other