BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS SYMFONY TORIC

    MDR report key: 9827995 · Received March 13, 2020

    Report

    Report Number
    9614546-2020-00123
    Event Type
    Injury
    Date Received
    March 13, 2020
    Report Date
    November 2, 2020
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    POE
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    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 IS DURING THE SUMMER 2019. IMPLANT DATE: IF IMPLANTED; GIVE DATE: UNKNOWN/NOT PROVIDED BEST ESTIMATE SUMMER 2019. EXPLANT DATE: IF EXPLANTED; GIVE DATE: N/A (NOT APPLICABLE). LENS REMAINS IMPLANTED. THE DEVICE WAS NOT RETURNED AS IT REMAINS IMPLANTED, THEREFORE THE PRODUCT EVALUATION IS UNABLE TO BE PERFORMED. THE COMPLAINT ISSUE REPORTED COULD NOT BE VERIFIED AND NO PRODUCT DEFICIENCY COULD BE IDENTIFIED. MANUFACTURING RECORDS REVIEW: THE MANUFACTURING RECORDS ARE UNABLE TO BE EVALUATED DUE TO NO SERIAL NUMBER RECEIVED. HISTORICAL DATA ANALYSIS: A SEARCH OF COMPLAINTS RELATED TO THIS PRODUCTION ORDER (PO) WAS UNABLE TO BE PERFORMED DUE TO NO SERIAL NUMBER BEING RECEIVED. CONCLUSION: AS A RESULT OF THE INVESTIGATION THERE IS NO INDICATION OF A QUALITY PRODUCT DEFICIENCY AND THE REPORTED ISSUE COULD NOT BE VERIFIED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER ACCOUNT REPORTED THAT A PATIENT WHO HAD A SYMFONY TORIC INTRAOCULAR LENS (IOL) IMPLANTED IN THE RIGHT (OD) EYE AND A MULTIFOCAL IN THE LEFT (OS) EYE APPROXIMATELY IN THE SUMMER 2019. PATIENT IS HAPPY WITH THE LEFT, BUT HAS NEGATIVE DYSPHOTOPSIA IN THE RIGHT WITH A DARKENED, BLURRED FEELING FROM FIXATION TEMPORALLY. NO SIGNIFICANT SURFACE DISEASE AND MINIMAL CAPSULAR OPACIFICATION. THE LENS IS ROTATED TO 35 DEGREES. SHE IS 7 MONTHS POST-OP AND HAS RESIDUAL ASTIGMATISM: OD +1-1.5@19. 20/25 J3; OS PLANO 20/15 J1+. THE LENS COULD BE ROTATED TO DECREASE THE ASTIGMATISM. THERE IS NO PLAN FOR LENS EXCHANGE AT THIS TIME. NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293041 TECNIS SYMFONY TORIC MULTIFOCAL IOLS POE JOHNSON & JOHNSON SURGICAL VISION, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention