BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS SYMFONY

    MDR report key: 8598023 · Received May 9, 2019

    Report

    Report Number
    9614546-2019-00440
    Event Type
    Injury
    Date Received
    May 9, 2019
    Report Date
    November 11, 2020
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    MFK
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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 (B)(4) AND CAPA-010215.

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: PRODUCT TESTING COULD NOT BE PERFORMED BECAUSE THE PRODUCT WAS NOT RETURNED. A PRODUCT QUALITY DEFICIENCY COULD NOT BE CONFIRMED. THE REPORTED ISSUE WAS NOT VERIFIED. MANUFACTURING RECORDS REVIEW: THE MANUFACTURING RECORD CANNOT BE REVIEWED SINCE THE IOL SERIAL NUMBER IS UNKNOWN. HISTORICAL DATA ANALYSIS: THE COMPLAINT HISTORY WAS NOT REVIEWED SINCE THE IOL SERIAL NUMBER IS UNKNOWN. LABELING REVIEW: THE LABELING REVIEW WAS NOT REVIEWED BECAUSE LIMITED INFORMATION WAS RECEIVED. CONCLUSION: AS A RESULT OF THE INVESTIGATION, CONSIDERING THE LIMITED INFORMATION AVAILABLE IT CANNOT BE DETERMINED IF THERE IS A PRODUCT MALFUNCTION. THE REPORTED ISSUE COULD NOT BE VERIFIED AS PRODUCT WAS NOT RETURNED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    EXPIRATION DATE: UNKNOWN, AS PRODUCT SERIAL NUMBER WAS NOT PROVIDED. SERIAL NUMBER: UNKNOWN, AS INFORMATION WAS NOT PROVIDED. UDI NUMBER: UNKNOWN, AS PRODUCT SERIAL NUMBER WAS NOT PROVIDED. CATALOG NUMBER: A COMPLETE CATALOG NUMBER IS UNKNOWN, AS PRODUCT SERIAL NUMBER WAS NOT PROVIDED. IF IMPLANTED, GIVE DATE: UNKNOWN, AS INFORMATION WAS NOT PROVIDED. IF EXPLANTED, GIVE DATE: NOT APPLICABLE, PLANNED EXPLANT FOR 04/12/2019, HOWEVER NOT YET CONFIRMED. DEVICE MANUFACTURE DATE: UNKNOWN, AS PRODUCT SERIAL NUMBER WAS NOT PROVIDED. (B)(4). ATTEMPTS WERE MADE TO CONTACT THE CUSTOMER ACCOUNT REQUESTING ADDITIONAL INFORMATION HOWEVER, TO DATE NO RESPONSE HAS BEEN RECEIVED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A MODEL ZXR00 INTRAOCULAR LENS (IOL) WILL BE EXPLANTED FROM THE PATIENT¿S OPERATIVE EYE ON (B)(6) 2019. ATTEMPTS WERE MADE TO CONTACT THE CUSTOMER ACCOUNT REQUESTING ADDITIONAL INFORMATION HOWEVER, TO DATE NO RESPONSE HAS BEEN RECEIVED. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    387423 TECNIS SYMFONY MULTIFOCAL IOLS MFK JOHNSON & JOHNSON SURGICAL VISION, INC. ZXR00

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention