BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS SYNERGY

    MDR report key: 7860932 · Received September 10, 2018

    Report

    Report Number
    9614546-2018-00878
    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
    TN, 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: ZYR00 20.5(OS)- SN: (B)(4). THE FOLLOWING FIELDS HAVE BEEN UPDATED ACCORDINGLY: 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. 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 (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 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

    THE SERIAL NUMBER OF THE DEVICE WAS NOT PROVIDED. (B)(4). ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    OS (LEFT EYE) IMPLANTATION DATE: (B)(6) 2018. BCVA (BEST CORRECTED VISUAL ACUITY): OS 20/20 OU (BOTH EYES) 20/20. IT WAS REPORTED IN THE 1-MONTH VISIT THAT THE SUBJECT HAD HALOS, STARBURST AND WAS SENSITIVE TO LIGHT, WHICH ARE VERY BOTHERSOME TO HER WHEN DRIVING AT NIGHT AFTER IMPLANTING MULTIFOCAL INTRAOCULAR LENS (IOL). IT WAS ALSO NOTED THAT VERY LITTLE RESIDUAL REFRACTIVE ERROR, NORMAL TOPOGRAPHY, AND WELL-CENTERED LENS WERE OBSERVED. THERE WAS NO EXPLANT PLANNED AT THIS TIME SINCE THE SUBJECT DOES NOT WANT TO LOSE HER NEAR VISION AND THERE WAS NO PATIENT INJURY OCCURRED. AFTER 6-MONTH VISIT, THE SUBJECT WAS STILL EXPERIENCING THE SAME SYMPTOMS FROM INITIAL VISIT AND STILL CONSIDERED THEM DEBILITATING. FURTHERMORE, THE SUBJECT CONSIDERED THEM UNBEARABLE, SO SHE WANTED TO REMOVE THE LENS. AS A RESULT, OS IOL WAS EXPLANTED ON (B)(6) 2018 PER FOLLOW-UP. OU BCDVA (BEST CORRECTED DISTANCE VISUAL ACUITY): 20/16. NO ADDITIONAL INFORMATION PROVIDED. THIS REPORT PERTAINS TO OS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    700605 TECNIS SYNERGY MULTIFOCAL IOLS MFK JOHNSON & JOHNSON SURGICAL VISION, INC. ZYR00

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention