BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS SYMFONY TORIC

    MDR report key: 8673190 · Received June 6, 2019

    Report

    Report Number
    9614546-2019-00515
    Event Type
    Injury
    Date Received
    June 6, 2019
    Report Date
    November 12, 2020
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    MFK
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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 · 0

    DEVICE EVALUATION: PRODUCT TESTING COULD NOT BE PERFORMED BECAUSE THE PRODUCT WAS NOT RETURNED. THE COMPLAINT CANNOT BE CONFIRMED. MANUFACTURING RECORD REVIEW: THE MANUFACTURING RECORD CANNOT BE REVIEWED SINCE THE SERIAL NUMBER IS UNKNOWN. THE COMPLAINT HISTORY COULD NOT BE REVIEWED SINCE THE SERIAL NUMBER IS UNKNOWN. BASED ON THE LIMITED INFORMATION AVAILABLE, IT CANNOT BE DETERMINED IF THERE WAS A PRODUCT MALFUNCTION. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN, NOT PROVIDED, BUT THE BEST ESTIMATE DATE IS DURING (B)(6) 2019. SERIAL NUMBER: UNKNOWN, INFORMATION NOT PROVIDED. CATALOG NUMBER: A COMPLETE CATALOG NUMBER IS UNKNOWN AS THE SERIAL NUMBER WAS NOT PROVIDED. UNIQUE DEVICE IDENTIFIER (UDI #): UNKNOWN, AS SERIAL NUMBER WAS NOT PROVIDED. EXPIRATION DATE: UNKNOWN, AS SERIAL NUMBER WAS NOT PROVIDED. IF IMPLANTED, GIVE DATE: UNKNOWN, INFORMATION NOT PROVIDED. IF EXPLANTED, GIVE DATE: UNKNOWN, INFORMATION NOT PROVIDED. DEVICE MANUFACTURE DATE: UNKNOWN AS SERIAL NUMBER WAS NOT PROVIDED. (B)(4). ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A TECNIS SYMFONY TORIC INTRAOCULAR LENS WAS EXPLANTED. NO OTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    469698 TECNIS SYMFONY TORIC MULTIFOCAL IOLS MFK JOHNSON & JOHNSON SURGICAL VISION, INC. ZXT100

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention