BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS SYMFONY

    MDR report key: 7933355 · Received October 4, 2018

    Report

    Report Number
    9614546-2018-00939
    Event Type
    Injury
    Date Received
    October 4, 2018
    Report Date
    November 3, 2020
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    POE
    UDI-DI
    05050474579101
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    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 · 0

    DEVICE EVALUATION: THE PRODUCT WAS NOT RETURNED. THE COMPLAINT CANNOT BE CONFIRMED. MANUFACTURING RECORDS REVIEW: 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. THE SEARCH REVEALED THAT NO SIMILAR COMPLAINTS WERE RECEIVED FOR THIS PRODUCTION ORDER NUMBER. LABELING REVIEW: THE LABELING REVIEW WAS COMPLETED AND REVEALED THAT THE DIRECTIONS FOR USE (DFU) PROVIDE THE CUSTOMER WITH PROPER USAGE INSTRUCTIONS AND GUIDELINES. NO LABELING CHANGES ARE REQUIRED. THE SEARCH REVEALED THAT NO SIMILAR COMPLAINTS WERE RECEIVED FOR THIS PRODUCTION ORDER NUMBER. AS A RESULT OF THE INVESTIGATION THERE IS NO INDICATION OF A 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 · 1

    DATE OF EVENT: UNKNOWN, BUT THE BEST ESTIMATE DATE IS BETWEEN (B)(6) 2017 AND (B)(6) 2018. IF EXPLANTED; GIVE DATE: N/A (NOT APPLICABLE) AS THE LENS REMAINS IMPLANTED AND THEREFORE NOT EXPLANTED. THE INTRAOCULAR LENS (IOL) IS NOT RETURNING FOR EVALUATION AS IT REMAINS IMPLANTED; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. A REVIEW OF THE DEVICE HISTORY RECORD, LABELING, COMPLAINT TRENDING, AND RISK DOCUMENTATION FOR THIS DEVICE WILL BE PERFORMED. UPON COMPLETION OF THE REVIEW, IF THERE IS ANY FURTHER RELEVANT INFORMATION A SUPPLEMENTAL MEDWATCH WILL BE FILED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    A FEMALE PATIENT REPORTED HAVING SEVERAL ISSUES AFTER BILATERAL INTRAOCULAR LENS (ZXR00) IMPLANT. SHE IS EXPERIENCING HUGE HALOS WHEN LOOKING AT THE MOON AND DRIVING AT NIGHT WITH ONCOMING TRAFFIC LIGHT. READING IS VERY UNCOMFORTABLE WITH HER EXCESSIVE BLINKING. ADDITIONAL INFORMATION WAS RECEIVED AND THE PATIENT REVEALED THAT THE SYMPTOMS SIGNIFICANTLY AFFECT HER DAILY LIFE AS SHE CANNOT DRIVE AT NIGHT AND HAS EXCESSIVE BLINKING DURING DAY AND NIGHT AS WELL. REPORTEDLY, YTTRIUM ALUMINUM GARNET (YAG) PROCEDURE WAS PERFORMED ON (B)(6) 2017, BUT IT DID NOT HELP. AS ADVISED BY HER SURGEON, THE PATIENT ORDERED +1 READING GLASSES. NO PLANS TO EXPLANT THE LENSES. THIS REPORT PERTAINS TO RIGHT EYE (OD). A SEPARATE REPORT WILL BE SUBMITTED FOR THE LEFT EYE (OS).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    775839 TECNIS SYMFONY MULTIFOCAL IOLS POE JOHNSON & JOHNSON SURGICAL VISION, INC. ZXR00 05050474579101

    Patients

    Seq Age Sex Outcome Treatment
    1 Other