BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS SYMFONY

    MDR report key: 7488564 · Received May 4, 2018

    Report

    Report Number
    9614546-2018-00433
    Event Type
    Injury
    Date Received
    May 4, 2018
    Date of Event
    October 12, 2017
    Report Date
    August 9, 2018
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    POE
    UDI-DI
    05050474579125
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    IF EXPLANTED; GIVE DATE: N/A. THE LENS REMAINS IMPLANTED. (B)(4). THE INTRAOCULAR LENS (IOL) IS NOT RETURNING FOR EVALUATION AS IT REMAINS IMPLANTED; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. A REVIEW OF THE DEVICE 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, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION IS BEING REPORTED. LABELED FOR SINGLE USE: THIS FIELD WAS INADVERTENTLY LEFT BLANK IN THE INITIAL MDR REPORT. IT SHOULD HAVE BEEN INDICATED YES. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT SHE WAS HAVING DIFFICULTY DRIVING AT NIGHT DUE TO GLARE ON THE LEFT EYE (OS) AFTER THE SURGERY AND WAS CONTINUOUSLY EXPERIENCING VISUAL DISTURBANCE. PER ACCOUNT, DURING THE DAY THERE WAS NO ISSUE WITH GLARE OR ''SPIDER WEBS'', BUT HER VISION IS STILL NOT GOOD. THE PHYSICIAN ADVISED HER TO WAIT TILL SYMPTOMS DISAPPEAR AND VISION IMPROVES. FOR THAT REASON, THE DOCTOR DECIDED NOT TO PURSUE ANY LASER TREATMENTS AT THIS TIME. THE PATIENT'S VISUAL ACUITY PRE-OPERATIVE WAS 20/40 AND POST-OPERATIVE WAS STILL 20/40. PER PATIENT, HER NEAR VISION IS FINE, BUT DISTANT VISION IS STILL EXPERIENCING SOME ISSUES. AS A RESULT, THE PATIENT'S VISION HAS NOT IMPROVED DUE TO GLARE AND ''SPIDER WEBS''. IOL REMAINS IMPLANTED AND A PLANNED OR PERFORMED INTERVENTION IS NOT REQUIRED AT THIS TIME. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328654 TECNIS SYMFONY MULTIFOCAL IOLS POE JOHNSON & JOHNSON SURGICAL VISION, INC. ZXR00 05050474579125

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other