BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS SYMFONY

    MDR report key: 7716883 · Received July 24, 2018

    Report

    Report Number
    9614546-2018-00713
    Event Type
    Injury
    Date Received
    July 24, 2018
    Report Date
    October 30, 2020
    Manufacturer
    JOHNSON AND JOHNSON SURGICAL VISION, INC.
    Product Code
    POE
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    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

    DATE OF EVENT: UNKNOWN/NOT PROVIDED; BEST ESTIMATE (B)(6) 2017. IMPLANT DATE: IF IMPLANTED; GIVE DATE: (B)(6) 2017. EXACT IMPLANT DATE IS UNKNOWN/NOT PROVIDED. EXPLANT DATE: IF EXPLANTED; GIVE DATE: THE LENS REMAINS IMPLANTED. THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE LENS REMAINS IMPLANTED. THE SERIAL NUMBER FOR THIS DEVICE IS NOT AVAILABLE; THEREFORE, NO FURTHER INVESTIGATION CAN BE PERFORMED. IF THERE IS ANY FURTHER RELEVANT INFORMATION RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4). ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    A PATIENT CONTACTED JOHNSON & JOHNSON VISION TO REPORT HER EXPERIENCE WITH SYMFONY LENS IMPLANTS IN BOTH EYES. REPORTEDLY, AROUND (B)(6) 2017, FOLLOWING THE EXPLANT OF A NON- J&J LENS DUE TO HIGHER ORDER ABERRATIONS (HOA), THE PATIENT HAD HER FIRST SYMFONY LENS IMPLANTED. ONE MONTH LATER, THE SECOND SYMFONY LENS WAS IMPLANTED IN THE OTHER EYE, REPLACING A NON J&J LENS. ONE MONTH LATER, YAG CAPSULOTOMY WAS DONE ON BOTH EYES DUE TO REPORTED HAZINESS AND THE YAG CAPSULOTOMY IMPROVED THE VISION CLARITY. THREE MONTHS LATER, A LASIK PROCEDURE WAS PERFORMED IN THE RIGHT EYE TO ADDRESS A REFRACTIVE ERROR. THREE MONTHS LATER, A SECOND LASIK PROCEDURE WAS PERFORMED IN THE RIGHT EYE. THE VISION IS NOW OK FOR CLOSE-UP, BUT THE PATIENT STILL HAS HOA, AND STATED AS DOUBLE VISION, GHOSTING OCCURS DAY AND NIGHT, WITH VIBRATION AROUND FLUORESCENT LIGHTS. THE PATIENT¿S DOMINANT EYE HAS CLEAR VISION OUT TO ABOUT 6 METERS. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON AND JOHNSON SURGICAL VISION, INC. NOTE: 2 MDR¿S TO BE SUBMITTED, ONE FOR EACH AFFECTED EYE. THIS REPORT DOCUMENTS THE DETAILS PERTAINING TO THE LEFT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    557738 TECNIS SYMFONY MULTIFOCAL IOLS POE JOHNSON AND JOHNSON SURGICAL VISION, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention