BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS SYMFONY TORIC

    MDR report key: 7501689 · Received May 10, 2018

    Report

    Report Number
    9614546-2018-00451
    Event Type
    Injury
    Date Received
    May 10, 2018
    Date of Event
    June 7, 2017
    Report Date
    May 9, 2018
    Manufacturer
    JOHNSON AND JOHNSON SURGICAL VISION, INC.
    Product Code
    POE
    UDI-DI
    05050474574489
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LENS REMAINS IMPLANTED AND THEREFORE NOT EXPLANTED. (B)(6). IT WAS INDICATED THAT THE DEVICE REMAINS IMPLANTED; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. A REVIEW OF THE DEVICE/LOT 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 HALOES AND GLARES 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. 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 COMORBIDITIES. NO LOSS OF BEST SPECTACLE CORRECTED VISUAL ACUITY (BSCVA). PATIENT¿S POST-OP BSCVA WAS 6/5. SPECTACLES HAVE BEEN PROVIDED TO THE PATIENT WHICH IMPROVE THE UNAIDED VISION. GLARE HAS BEEN REDUCED BY THE SPECTACLES, BUT NOT ELIMINATED. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON AND JOHNSON SURGICAL VISION, INC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    347117 TECNIS SYMFONY TORIC MULTIFOCAL IOLS POE JOHNSON AND JOHNSON SURGICAL VISION, INC. ZXT150 05050474574489

    Patients

    Seq Age Sex Outcome Treatment
    1 Other