BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS SYMFONY

    MDR report key: 8909852 · Received August 20, 2019

    Report

    Report Number
    9614546-2019-00753
    Event Type
    Injury
    Date Received
    August 20, 2019
    Date of Event
    January 8, 2016
    Report Date
    November 10, 2020
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    MFK
    UDI-DI
    05050474575660
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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

    AGE / DATE OF BIRTH: UNKNOWN / NOT PROVIDED. SEX / GENDER: UNKNOWN / NOT PROVIDED IF IMPLANTED; GIVE DATE: (B)(6) 2019. IF EXPLANTED; GIVE DATE: INTRAOCULAR LENS STILL IMPLANTED IN THE PATIENT EYE. (B)(6). THE INTRAOCULAR LENS (IOL) IS NOT RETURNING FOR EVALUATION AS IT REMAINS IMPLANTED; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. MANUFACTURING RECORDS REVIEW: THE MANUFACTURING RECORDS FOR THE PRODUCT WERE REVIEWED. THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATION. A SEARCH REVEALED THAT NO SIMILAR (AS APPLICABLE) COMPLAINTS FOR THIS ORDER NUMBER HAVE BEEN RECEIVED. CONCLUSION: AS A RESULT OF THE INVESTIGATION, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SURGERY TOOK PLACE ON THE (B)(6) 2019 WHERE A MULTIFOCAL LENS, MODEL ZXR HAVE BEEN IMPLANTED. THE PATIENTS NOTICED THAT DISTANCE VISUAL ACUITY WAS BETTER THAN 6/6 PRIOR TO SURGERY. VISION IS WORSE THAN IT WAS PRIOR TO SURGERY AT ALL DISTANCES. HE REQUIRES TO WEAR GLASSES. HE SEES STARBURSTS GLARE AND HALOES. HE HAS SUFFERED A LOSS OF CONTRAST PERCEPTION AND STRUGGLES WITH DEPTH PERCEPTION. HE IS UNABLE TO DRIVE IN THE DARK DUE TO DYSPHOTOPSIA. HIS VISION IS GREASY AND BLURRED. IT IS DETERIORATING. THE PATIENT HAS ATTENDED HIS GP AND HAS BEEN REFERRED TO HIS LOCAL HOSPITAL. ALL INFORMATION AVAILABLE WERE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    706028 TECNIS SYMFONY MULTIFOCAL IOLS MFK JOHNSON & JOHNSON SURGICAL VISION, INC. ZXR00 05050474575660

    Patients

    Seq Age Sex Outcome Treatment
    1 Other