BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS SYMFONY

    MDR report key: 8909671 · Received August 20, 2019

    Report

    Report Number
    9614546-2019-00749
    Event Type
    Injury
    Date Received
    August 20, 2019
    Report Date
    November 11, 2020
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    POE
    UDI-DI
    05050474579132
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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

    DEVICE EVALUATION: THE PRODUCT WAS NOT RETURNED TO THE MANUFACTURING SITE; THEREFORE, THE COMPLAINT ISSUE REPORTED WAS NOT VERIFIED. MANUFACTURING RECORDS REVIEW: THE MANUFACTURING RECORDS FOR THE PRODUCT WERE REVIEWED. THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATION. HISTORICAL DATA ANALYSIS: A SEARCH OF COMPLAINTS REVEALED NO SIMILAR COMPLAINTS WERE RECEIVED FOR THIS PRODUCTION ORDER NUMBER. CONCLUSION: AS A RESULT OF THE INVESTIGATION THERE IS NO INDICATION OF A QUALITY PRODUCT DEFICIENCY AND THE REPORTED ISSUE COULD NOT BE VERIFIED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    IN INITIAL REPORT, DATE RECEIVED BY MANUFACTURER WAS INCORRECT. THE CORRECT DATE SHOULD HAVE SPECIFIED 7/31/2019. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN, NOT PROVIDED; BEST ESTIMATE IS BETWEEN (B)(6) 2019 AND (B)(6) 2019. (B)(4). ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    JOHNSON AND JOHNSON SURGICAL VISION (JJSV) ACCOUNT REPRESENTATIVE REPORTED THAT A HEALTHCARE PROVIDER (HCP) WHO HAS AN UNHAPPY PATIENT. PATIENT IS STATUS-POST LASIK, IMPLANTED WITH A ZXR00 22.0 DIOPTER INTRAOCULAR LENS (IOL) WHICH RESULTED IN A MYOPIC OUTCOME. PATIENT'S VISUAL ACUITY WITH APPROXIMATELY -1.25 IS 20/20, NO LOSS OF BEST CORRECTED VISION. THE LENS WAS LATER EXPLANTED ON (B)(6) 2019 IN EXCHANGE FOR A MONOFOCAL LENS. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    705543 TECNIS SYMFONY MULTIFOCAL IOLS POE JOHNSON & JOHNSON SURGICAL VISION, INC. ZXR00 05050474579132

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention