BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS SYNERGY

    MDR report key: 7649213 · Received June 28, 2018

    Report

    Report Number
    2648035-2018-00925
    Event Type
    Injury
    Date Received
    June 28, 2018
    Date of Event
    May 31, 2018
    Report Date
    December 13, 2018
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    MFK
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EXPLANT DATE: IF EXPLANTED, GIVE DATE: NOT APPLICABLE, AS THE LENS REMAINS IMPLANTED. HOWEVER, THERE IS A PLANNED INTERVENTION SCHEDULED IN THE NEXT MONTH, BUT WITH NO SET DATE YET. (B)(4). ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: NEW INFORMATION RECEIVED ON 9/11/2018 REPORTED THE PATIENT CONCLUDED THE STUDY (B)(6) 2018. PATIENT HAD LASIK (B)(6) 2018 IN HER RIGHT EYE (OD). IN THE INITIAL MDR, IT WAS REPORTED THAT THE OUTCOME SIGNIFICANTLY INTERFERED WITH ACTIVITIES OF DAILY LIFE. THIS INFORMATION WAS INCORRECTLY REPORTED AND SHOULD HAVE BEEN INDICATED THAT THE OUTCOME DID NOT SIGNIFICANTLY INTERFERE WITH ACTIVITIES OF DAILY LIFE. THE INITIAL MDR INADVERTENTLY DID NOT CAPTURE REPORT SOURCE STUDY. THE FOLLOWING HAS BEEN UPDATED ACCORDINGLY: REPORT SOURCE: STUDY. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    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#: ZFR00U0180. 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 THE REPORTED EVENT IS NOW DETERMINED NOT MDR REPORTABLE. NO FURTHER INFORMATION WILL BE PROVIDED FOR THIS EVENT UNDER MDR NUMBER 2648035-2018-00925. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN INTRAOCULAR LENS WAS IMPLANTED IN THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2018. POST-OPERATIVELY, THE PATIENT WAS VERY BOTHERED BY HALOS, GLARE, STARBURSTS, SENSITIVITY TO LIGHT, STREAKS OF LIGHT, AND OCCLUSIONS (FIXED DARK OR LIGHT BLOCKED AREAS WITHIN THE VISION THAT DO NOT COME AND GO). THE PATIENT WAS ALSO EXTREMELY BOTHERED BY POOR LOW LIGHT VISION AND HAS DIFFICULTY DRIVING DUE TO GLARE FROM ONCOMING HEADLIGHTS. FURTHERMORE, THESE OUTCOMES SIGNIFICANTLY INTERFERE WITH ACTIVITIES OF DAILY LIFE FOR THE PATIENT. REPORTEDLY, THE PATIENT'S BEST CORRECTED DISTANCE VISUAL ACUITY (BCDVA) IN BOTH EYES (OU) WAS 20/25+. THERE IS SURGICAL INTERVENTION PLANNED WITHIN THE NEXT MONTH, BUT NO DATE HAS BEEN SET YET. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS COMPLAINT FOLDER WILL CAPTURE THE EVENT PERTAINING TO THE PATIENT'S LEFT EYE. THE RIGHT EYE WILL BE CAPTURED IN ANOTHER REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    489690 TECNIS SYNERGY MULTIFOCAL IOLS MFK JOHNSON & JOHNSON SURGICAL VISION, INC. ZFR00

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention