BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS SYMFONY

    MDR report key: 7501691 · Received May 10, 2018

    Report

    Report Number
    9614546-2018-00450
    Event Type
    Injury
    Date Received
    May 10, 2018
    Report Date
    May 9, 2018
    Manufacturer
    JOHNSON AND JOHNSON SURGICAL VISION, INC.
    Product Code
    POE
    UDI-DI
    05050474577190
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT IS UNKNOWN/NOT PROVIDED. IF EXPLANTED, GIVE DATE: NOT APPLICABLE AS TO DATE THE LENS REMAINS IMPLANTED AND THEREFORE NOT EXPLANTED. (B)(6). TO DATE THE LENS 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. (B)(4). ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING IMPLANTATION OF A SYMFONY LENS, THE PATIENT HAD SEVERE HALOS AND GLARE DURING THE DAY AND NIGHT. THEY CANNOT DRIVE CONFIDENTLY AT NIGHT AND HAVE POOR PERIPHERAL/MIDFIELD VISION AS WELL AS POOR EYESIGHT. THE PATIENT STILL REQUIRES GLASSES. REPORTEDLY, THE SPECTACLES IMPROVE THE PATIENT'S UNAIDED VISION AND REDUCED THE SYMPTOMS OF GLARE. BUT THEY HAVE NOT BEEN ELIMINATED. NO SURGICAL OR MEDICAL INTERVENTION HAS BEEN PERFORMED. HOWEVER, THE PATIENT HAS BEEN OFFERED A MONOFOCAL EXCHANGE. THE PATIENT DOESN¿T HAVE PRE-EXISTING OR CURRENT MEDICAL CONDITIONS. THE SURGEON BELIEVES THIS IS A CASE OF NEURO-ADAPTION. THE PATIENT WAS FOUND TO BE A GOOD CANDIDATE FOR THIS TYPE OF LENS. THERE ARE NO ASSOCIATED CO-MORBIDITIES. NO LOSS OF BEST SPECTACLE CORRECTED VISUAL ACUITY (BSCVA).PATIENT¿S POST-OP BSCVA WAS 6/5. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON AND JOHNSON SURGICAL VISION, INC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    347119 TECNIS SYMFONY MULTIFOCAL IOLS POE JOHNSON AND JOHNSON SURGICAL VISION, INC. ZXR00 05050474577190

    Patients

    Seq Age Sex Outcome Treatment
    1 Other