BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS SYMFONY

    MDR report key: 8815820 · Received July 23, 2019

    Report

    Report Number
    9614546-2019-00639
    Event Type
    Injury
    Date Received
    July 23, 2019
    Report Date
    November 12, 2020
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    MFK
    UDI-DI
    05050474579118
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    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 (B)(4), AND CAPA-010215.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN, NOT PROVIDED, BUT THE BEST ESTIMATE DATE IS (B)(6) 2017. TO DATE THE LENS REMAINS IMPLANTED. THE DEVICE IS NOT RETURNING FOR EVALUATION AS TO DATE IT REMAINS IMPLANTED; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. THE IF THERE IS ANY FURTHER RELEVANT INFORMATION RECEIVED, 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 A PATIENT REPORTED HAVING BLURRED VISION AND ISSUES WITH DEPTH PERCEPTION AFTER AN INTRAOCULAR LENS IMPLANTATION. THE SYMPTOMS WERE REPORTED TO THE SURGERY CENTER IN (B)(6) 2017. IN (B)(6) 2017, THE PATIENT HAD A YAG (YTTRIUM ALUMINIUM GARNET) PROCEDURE PERFORMED BUT REPORTED THERE WAS NO IMPROVEMENT WITH THE SYMPTOMS. IN (B)(6) 2018, THE PATIENT REPORTED DRY EYE AND RESTASIS WAS PRESCRIBED TO ALLEVIATE THE SYMPTOMS. IN ADDITION, CONTACT LENSES WERE PRESCRIBED WHICH HELPED FOR READING BUT NOT FOR DISTANCE. THE PATIENT REPORTED THAT THE LACK OF DEPTH PERCEPTION HAS SIGNIFICANTLY AFFECTED HER ABILITY TO PERFORM DAILY ACTIVITIES. THE PATIENT¿S COMMENTS WERE OF THE INTRAOCULAR LENSES (IOLS) DON'T WORK BUT DID NOT WANT THEM TAKEN OUT. NO ADDITIONAL PROCEDURES HAVE BEEN PERFORMED OR ARE PLANNED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    610156 TECNIS SYMFONY MULTIFOCAL IOLS MFK JOHNSON & JOHNSON SURGICAL VISION, INC. ZXR00 05050474579118

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other