BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS SYMFONY

    MDR report key: 8978477 · Received September 10, 2019

    Report

    Report Number
    9614546-2019-00847
    Event Type
    Injury
    Date Received
    September 10, 2019
    Report Date
    November 10, 2020
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    POE
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KR
    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-(B)(4) AND CAPA-010215.

    Additional Manufacturer Narrative · 1

    AGE/DATE OF BIRTH: EXACT AGE UNKNOWN, NOT PROVIDED. RANGE IS 17- 67 YEARS. GENDER/SEX: UNKNOWN, INFORMATION NOT PROVIDED. DATE OF EVENT: UNKNOWN, NOT PROVIDED. MODEL #: THE MODEL # IS UNKNOWN AS SERIAL NUMBER WAS NOT PROVIDED. CATALOG #: THE CATALOG # IS UNKNOWN AS SERIAL NUMBER WAS NOT PROVIDED. UNIQUE IDENTIFIER (UDI#): UNKNOWN, AS SERIAL NUMBER WAS NOT PROVIDED. EXPIRATION DATE: UNKNOWN, AS SERIAL NUMBER WAS NOT PROVIDED. IF IMPLANTED, GIVE DATE: UNKNOWN, INFORMATION NOT PROVIDED. IF EXPLANTED, GIVE DATE: UNKNOWN, INFORMATION NOT PROVIDED. INITIAL REPORTER PHONE NUMBER: UNKNOWN, NOT PROVIDED THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE SERIAL NUMBER FOR THE DEVICE WAS NOT AVAILABLE; THEREFORE, NO FURTHER INVESTIGATION CAN BE PERFORMED. IF THERE IS ANY FURTHER RELEVANT INFORMATION RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN AS SERIAL NUMBER WAS NOT PROVIDED. (B)(4). CITATION: SE HYUN CHOI, HYO KYUNG LEE, CHANG HO YOON AND MEE KUM KIM (2019). VISUAL PERFORMANCE AFTER A UNILATERAL OR BILATERAL IMPLANTATION OF ENLARGED DEPTH-OF-FOCUS INTRAOCULAR LENS IN PATIENTS WITH CATARACT: A PROSPECTIVE CLINICAL TRIAL. JOURNAL OF OPHTHALMOLOGY 2019, ARTICLE ID 2163809, 8 PAGES. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    ARTICLE: VISUAL PERFORMANCE AFTER A UNILATERAL OR BILATERAL IMPLANTATION OF ENLARGED DEPTH-OF-FOCUS INTRAOCULAR LENS IN PATIENTS WITH CATARACT: A PROSPECTIVE CLINICAL TRIAL AUTHORS: SE HYUN CHOI, HYO KYUNG LEE, CHANG HO YOON AND MEE KUM KIM. PUBLICATION: JOURNAL OF OPHTHALMOLOGY 2019, ARTICLE ID 2163809, 8 PAGES. THE PUBLICATION REPORTS TWO PATIENTS COMPLAINED OF GLARE SYMPTOMS POSTOPERATIVE AT 12 WEEKS. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION. THIS REPORT IS FOR THE FIRST OF TWO PATIENTS. A SEPARATE MDR WILL BE SUBMITTED FOR THE OTHER REPORTED PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    773546 TECNIS SYMFONY MULTIFOCAL IOLS POE JOHNSON & JOHNSON SURGICAL VISION, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other