BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS SYMFONY

    MDR report key: 7746231 · Received August 3, 2018

    Report

    Report Number
    9614546-2018-00748
    Event Type
    Injury
    Date Received
    August 3, 2018
    Date of Event
    August 24, 2017
    Report Date
    November 2, 2020
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    POE
    UDI-DI
    05050474579149
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    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

    ADDITIONAL INFO: IT WAS LEARNT THAT CATARACT OPERATION WAS DONE ON (B)(6) 2017, AND PATIENT FOLLOWED UP POST OP TO ADDRESS HER SYMPTOMS OF PROLONGED IRRITATION, DISCOMFORT, AND LACK OF CLEAR VISION IN THE AFFECTED EYE. THE CORRECT SERIAL NUMBER FOR THE RIGHT EYE THAT WAS IMPLANTED IS (B)(4). SERIAL NUMBER: (B)(4). EXPIRATION DATE: (B)(6) 2022. IMPLANT DATE: (B)(6) 2017. MANUFACTURING DATE: 4/11/2017. PATIENT CODE: 1941. PATIENT CODE: 2330. ALL PERTINENT INFORMATION AVAILABLE JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    LENS REMAINS IMPLANTED IN THE EYE. IT WAS INDICATED THAT THE DEVICE IS NOT RETURNING FOR EVALUATION AS THE LENS REMAINS IMPLANTED; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. A REVIEW OF THE DEVICE/LOT HISTORY RECORD, LABELING, COMPLAINT TRENDING, AND RISK DOCUMENTATION FOR THIS DEVICE WILL BE PERFORMED. UPON COMPLETION OF THE REVIEW, IF THERE IS ANY FURTHER RELEVANT INFORMATION A SUPPLEMENTAL MEDWATCH WILL BE FILED. ATTEMPTS HAVE BEEN MADE TO OBTAIN MISSING INFORMATION; HOWEVER, TO DATE, NO RESPONSE HAS BEEN RECEIVED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE TECNIS SYMFONY MULTIFOCAL INTRAOCULAR LENS (MODEL ZXR00 +22.5 DIOPTER) WAS IMPLANTED IN THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2017. REPORTEDLY, IMMEDIATELY AFTER SURGERY THE PATIENT VISION WAS BLURRY; STARBURSTS AND HALOS WERE VISIBLE ON EVERYTHING AT NIGHT. LASER YAG (YTTRIUM ALUMINIUM GARNET) CAPSULOTOMY WAS DONE ON (B)(6) 2018 IN THE HOPE IT WOULD IMPROVE THE DISTANCE VISION, HOWEVER NO CHANGES NOTICED POST SECOND SURGERY. THE LENS REMAINS IMPLANTED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    590861 TECNIS SYMFONY MULTIFOCAL IOLS POE JOHNSON & JOHNSON SURGICAL VISION, INC. ZXR00 05050474579149

    Patients

    Seq Age Sex Outcome Treatment
    1 Other