BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS SYMFONY

    MDR report key: 8978381 · Received September 10, 2019

    Report

    Report Number
    9614546-2019-00845
    Event Type
    Injury
    Date Received
    September 10, 2019
    Report Date
    November 10, 2020
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    POE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    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 · 1

    AGE/DATE OF BIRTH: (MEAN AGE 59.7 ± 8.6 YEARS; RANGE 45 TO 78 YEARS). GENDER/SEX: MALE AND FEMALE. 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, 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: JEEWAN S. TITIYAL, MD, MANPREET KAUR, MD, NEHA BHARTI, BSC, DEEPALI SINGHAL, MD, ROHIT SAXENA, MD, NAMRATA SHARMA, MD (2019). OPTIMAL NEAR AND DISTANCE STEREOACUITY AFTER BINOCULAR IMPLANTATION OF EXTENDED RANGE OF VISION INTRAOCULAR LENSES. J CATARACT REFRACT SURG 2019, 45(6), PP798¿802. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    ARTICLE: OPTIMAL NEAR AND DISTANCE STEREOACUITY AFTER BINOCULAR IMPLANTATION OF EXTENDED RANGE OF VISION INTRAOCULAR LENSES. AUTHORS: JEEWAN S. TITIYAL, MD, MANPREET KAUR, MD, NEHA BHARTI, BSC, DEEPALI SINGHAL, MD, ROHIT SAXENA, MD, NAMRATA SHARMA, MD. PUBLICATION: J CATARACT REFRACT SURG 2019; 45:798¿802. THE PUBLICATION REPORTS THAT IN THE EARLY POSTOPERATIVE PERIOD, 10 PATIENTS DESCRIBED MILD TO MODERATE GLARE, 1 REPORTED SEVERE GLARE, 15 PATIENTS REPORTED MILD TO MODERATE HALO, 12 PATIENTS DESCRIBED DISTORTION OF VISION AT NEAR, AND 10 REPORTED DISTORTED VISION AT DISTANCE. AT ONE YEAR FOLLOW UP, 8 PATIENTS REPORTED MILD GLARE, 1 PATIENT REPORTED MODERATE GLARE, 14 PATIENTS REPORTED MILD HALOS, 4 PATIENTS REPORTED MILD NIGHT VISION DISTURBANCE, 3 PATIENTS REPORTED MILD TO MODERATE DISTORTION OF DISTANCE AND NEAR VISION, 6 PATIENTS REPORTED MILD NIGHT DRIVING DIFFICULTY, 1 REPORTED MILD DIFFICULTY WATCHING TV AND DOING OUTDOOR ACTIVITIES, AND 4 REPORTED READING DIFFICULTY. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    772356 TECNIS SYMFONY MULTIFOCAL IOLS POE JOHNSON & JOHNSON SURGICAL VISION, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other