BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS SYNERGY

    MDR report key: 7860769 · Received September 10, 2018

    Report

    Report Number
    9614546-2018-00876
    Event Type
    Injury
    Date Received
    September 10, 2018
    Date of Event
    May 9, 2018
    Report Date
    October 29, 2020
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    MFK
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    NEW INFORMATION WAS RECEIVED FROM CLINICAL STUDY ON 11/16/2018 THAT STUDY HAS BEEN UNMASKED. PRODUCT ID HAS BEEN PROVIDED: ZFR00 21.5(OS)- SN: (B)(4). THE FOLLOWING FIELDS HAVE BEEN UPDATED ACCORDINGLY: BRAND NAME: TECNIS SYNERGY. MODEL NUMBER: ZFR00. SERIAL NUMBER: (B)(4). CATALOG#: ZFR00U0215. EXPIRATION DATE: 10/16/2022. UDI NUMBER: (B)(4). DEVICE MANUFACTURE DATE: 10/16/2017. 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

    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

    BRAND NAME: UNKNOWN/NOT PROVIDED. SERIAL#: UNKNOWN/NOT PROVIDED. CATALOG#: A COMPLETE CATALOG # IS UNKNOWN, AS PRODUCT SERIAL NUMBER WAS NOT PROVIDED. EXPIRATION DATE: UNKNOWN AS PRODUCT SERIAL NUMBER WAS NOT PROVIDED. UDI #: A COMPLETE UDI # IS UNKNOWN AS PRODUCT SERIAL NUMBER WAS NOT PROVIDED. IF EXPLANTED; GIVE DATE: N/A. THE LENS REMAINS IMPLANTED. DEVICE MANUFACTURE DATE: UNKNOWN, AS THE SERIAL NUMBER OF THE DEVICE WAS NOT PROVIDED. (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 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

    OS (LEFT EYE) IMPLANT DATE: (B)(6) 2018. OU (BOTH EYES) BCDVA(BEST CORRECTED DISTANCE VISUAL ACUITY): 20/20. AT 1 MONTH VISIT, IT WAS REPORTED THAT PATIENT HAD BEEN BOTHERED WITH HALO, GLARE, STARBURSTS AND STREAKS OF LIGHT AFTER IMPLANTING MULTIFOCAL INTRAOCULAR LENS (IOL). PATIENT'S CURRENT SYMPTOMS MADE DRIVING AT NIGHT DIFFICULT ALSO. HOWEVER, THERE WAS NO PATIENT INJURY AND THERE WAS NO INTERVENTION REQUIRED AT THIS TIME AS THE PATIENT WANTED TO KEEP THE LENS. THROUGH FOLLOW-UP, PATIENT WAS STILL BOTHERED WITH HALOS, GLARE, STARBURST AND STREAKS OF LIGHT IN THE 6-MONTH VISIT. MOREOVER, THE SUBJECT STILL CONSIDERED THEM DEBILITATING. PATIENT'S BCDVA (BEST CORRECTED DISTANCE VISUAL ACUITY) ON BOTH EYES (OU) WAS 20/20-2. REPORTEDLY, THERE WAS NO PLANS FOR INTERVENTION AT THIS TIME. NO ADDITIONAL INFORMATION PROVIDED. THIS REPORT PERTAINS TO OS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    700553 TECNIS SYNERGY MULTIFOCAL IOLS MFK JOHNSON & JOHNSON SURGICAL VISION, INC. ZFR00

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other