BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS SYNERGY

    MDR report key: 7900359 · Received September 21, 2018

    Report

    Report Number
    9614546-2018-00903
    Event Type
    Injury
    Date Received
    September 21, 2018
    Date of Event
    August 24, 2018
    Report Date
    November 3, 2020
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    MFK
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, 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

    ADDITIONAL INFORMATION: THIS REPORT PERTAINS TO ZFR00 19.5 (OS) SN: (B)(4). 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: ZFR00. SERIAL NUMBER: (B)(4). CATALOG#: ZFR00U0195. EXPIRATION DATE: 10/13/2022. UDI NUMBER: (B)(4). DEVICE MANUFACTURE DATE: 10/13/2017. CORRECTED DATA: 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 (ZFR00), 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 AND THE REPORTED EVENT IS NOW DETERMINED NOT MDR REPORTABLE. NO FURTHER INFORMATION WILL BE PROVIDED FOR THIS EVENT. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    IN REVIEW OF THE FILE, THE INITIAL MDR REPORTED ''PRODUCT PROBLEM'' INCORRECTLY. THE REPORTED EVENT INCORRECTLY REPORTED BOTH EYES, BUT SHOULD HAVE BEEN REPORTING THE LEFT EYE (OS) ONLY. THE FOLLOWING HAS BEEN UPDATED ACCORDINGLY: THIS REPORT PERTAINS TO THE LEFT EYE (OS). A SEPARATE REPORT HAS BEEN SUBMITTED FOR THE RIGHT EYE (OD). ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    EXPLANT DATE: IF EXPLANTED; GIVE DATE: N/A (NOT APPLICABLE). THE LENS REMAINS IMPLANTED. (B)(4). 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 NOT BE PERFORMED AS A SERIAL NUMBER OF THE LENS WAS NOT PROVIDED. IF THERE IS ANY FURTHER RELEVANT INFORMATION PROVIDED, 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 PATIENT WAS EXTREMELY BOTHERED PARTICULARLY NIGHT DRIVING WITH HALOS. PATIENT WAS VERY BOTHERED WHEN DRIVING IN ALL CONDITIONS WITH GLARE, STARBURSTS, AND SENSITIVITY TO LIGHT. STREAKS OF LIGHT ARE MODERATELY BOTHERSOME WHEN DRIVING IN ALL CONDITIONS. BEST CORRECTED DISTANCE VISUAL ACUITY (BCDVA) IN BOTH EYES WAS 20/20. NO INTERVENTION PLANNED OR PERFORMED. THE LENS REMAINS IMPLANTED. NO ADDITIONAL INFORMATION PROVIDED. THIS REPORT PERTAINS TO THE RIGHT EYE (OD). THIS REPORT PERTAINS TO LEFT EYE (OS).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    737698 TECNIS SYNERGY MULTIFOCAL IOLS MFK JOHNSON & JOHNSON SURGICAL VISION, INC. ZFR00

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other