BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS SYNERGY

    MDR report key: 7832150 · Received August 30, 2018

    Report

    Report Number
    9614546-2018-00837
    Event Type
    Injury
    Date Received
    August 30, 2018
    Date of Event
    May 17, 2018
    Report Date
    October 30, 2020
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    MFK
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    INFORMATION RECEIVED THAT THE CLINICAL STUDY WAS UNMASKED AND THE PRODUCT IDENTIFIERS WERE PROVIDED. AS A RESULT, THE FOLLOWING FIELDS HAVE BEEN UPDATED. BRAND NAME: TECNIS SYNERGY. MODEL NUMBER: ZYR00. SERIAL NUMBER: (B)(4). CATALOG#: ZYR00U0205. EXPIRATION DATE: 10/18/2022. UDI NUMBER: (B)(4). DEVICE MANUFACTURE DATE: 10/18/2017. THE INITIAL REPORT WAS SUBMITTED UNDER A THEN UNKNOWN CLINICAL STUDY DEVICE. THE CLINICAL STUDY HAS NOW BEEN UNMASKED AND UPON LEARNING THE MODEL OF THE LENS (ZYR00), IT WAS REALIZED THAT THIS REPORT WAS SUBMITTED FOR AN INVESTIGATIONAL DEVICE THAT IS NOT SAME OR SIMILAR TO A MARKETED DEVICE IN THE UNITED STATES. THEREFORE, THE PMA NUMBER P980040 THAT WAS PROVIDED IN THE INITIAL FILING IS NOT APPLICABLE AS THE REPORTED EVENT IS NOW DETERMINED NOT MDR REPORTABLE. NO FURTHER INFORMATION WILL BE PROVIDED FOR THIS EVENT UNDER MDR NUMBER 9614546-2018-00837. 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

    IF EXPLANTED; GIVE DATE: NOT APPLICABLE. THE LENS REMAINS IMPLANTED. 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

    IT WAS REPORTED THAT A FEMALE SUBJECT IS BOTHERED BY HALOS WHEN DRIVING AT NIGHT AND HAVING DIFFICULTY WITH DISTANCE AND NEAR VISION. IT WAS NOTED ALSO THAT VISUAL SYMPTOMS LASTED LONGER THAN 3 MONTHS AND THE SUBJECT CONSIDERS THEM DEBILITATING. SUBJECT'S BCVA (BEST CORRECTED VISUAL ACUITY) WAS 20/16 FOR BOTH EYES (OU) AND UNVA (UNCORRECTED NEAR VISUAL ACUITY) WAS 20/32 OU. THERE IS NO INTERVENTION PLANNED AT THIS TIME AS THE LENS REMAINS IMPLANTED. NO ADDITIONAL INFORMATION PROVIDED. THIS REPORT PERTAINS TO LEFT EYE (OS) AND IS 2 OF 2 REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    675251 TECNIS SYNERGY MULTIFOCAL IOLS MFK JOHNSON & JOHNSON SURGICAL VISION, INC. ZYR00

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other