BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS SYMFONY

    MDR report key: 8093779 · Received November 21, 2018

    Report

    Report Number
    9614546-2018-01101
    Event Type
    Injury
    Date Received
    November 21, 2018
    Report Date
    November 5, 2020
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    POE
    UDI-DI
    05050474579132
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: PRODUCT TESTING COULD NOT BE PERFORMED BECAUSE THE PRODUCT WAS NOT RETURNED. THE COMPLAINT CANNOT BE CONFIRMED. MANUFACTURING RECORDS REVIEW: DURING THE MANUFACTURING RECORD REVIEW OF THE PRODUCTION ORDER FOR THIS SERIAL NUMBER, NO PRODUCT DEFICIENCY WAS IDENTIFIED. THE DOCUMENTATION SHOWS THAT THE PRODUCTION ORDER WAS MANUFACTURED ACCORDING TO SPECIFICATIONS. HISTORICAL DATA ANALYSIS: A SEARCH OF COMPLAINTS REVEALED THAT NO SIMILAR COMPLAINTS WERE RECEIVED FOR THIS PRODUCTION ORDER NUMBER. CONCLUSION: AS A RESULT OF THE INVESTIGATION THERE IS NO INDICATION OF A PRODUCT MALFUNCTION OR PRODUCT QUALITY DEFICIENCY AND THE REPORTED ISSUE COULD NOT BE VERIFIED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    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, BUT THE BEST ESTIMATE DATE IS BETWEEN (B)(6) 2017 AND (B)(6) 2018. IF EXPLANTED, GIVE DATE: NOT APPLICABLE, THE LENS WAS PLANNED TO BE EXPLANTED, BUT TO DATE NO CONFIRMATION HAS BEEN RECEIVED. (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 THE ZXR00 INTRAOCULAR LENS (IOL) IS PLANNED TO BE EXPLANTED FROM THE RIGHT EYE (OD) OF A FEMALE PATIENT. REPORTEDLY, THE IOL IN THE LEFT EYE (OS) HAS ALREADY BEEN EXPLANTED AND REPLACED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS MDR CAPTURES THE IMPLANT IN THE RIGHT EYE. A SEPARATE MDR HAS BEEN FILED FOR THE LEFT (OS) EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    933540 TECNIS SYMFONY MULTIFOCAL IOLS POE JOHNSON & JOHNSON SURGICAL VISION, INC. ZXR00 05050474579132

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention