BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS SYMFONY

    MDR report key: 9374837 · Received November 26, 2019

    Report

    Report Number
    9614546-2019-01065
    Event Type
    Injury
    Date Received
    November 26, 2019
    Report Date
    November 5, 2020
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    POE
    UDI-DI
    05050474575707
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ES
    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 (B)(4), AND CAPA-010215.

    Additional Manufacturer Narrative · 0

    THROUGH FOLLOW-UP WE LEARNED THAT THE PATIENT WAS OPERATED ON IN BOTH EYES WITH THE SAME RESULT. THE EXACT IMPLANTATION DATE IS UNKNOWN AS IT WAS PERFORMED IN ANOTHER HOSPITAL. THE UNEXPECTED POSTOPERATIVE REFRACTION DOES AFFECT THE PATIENT IN THEIR DAILY LIFE. AN EXPLANT IS BEING CONSIDERED BUT IT WOULD BE A RISKY SURGERY BECAUSE A YAG (YTTRIUM ALUMINUM GARNET) CAPSULOTOMY IN AO (AO Q-SWITCHED ND: YAG LASER WITH ONE OSCILLATOR-AMPLIFIER) WAS PERFORMED. NO ADDITIONAL INFORMATION WAS PROVIDED. DEVICE EVALUATION: THE INTRAOCULAR LENS (IOL) IS NOT RETURNING FOR EVALUATION AS IT REMAINS IMPLANTED. THEREFORE, AN EVALUATION OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. MANUFACTURING RECORD EVALUATION: THE MANUFACTURING RECORDS FOR THE INTRAOCULAR LENS WERE REVIEWED. THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATION. A SEARCH REVEALED THAT NO SIMILAR COMPLAINTS FOR THIS ORDER NUMBER HAVE BEEN RECEIVED. CONCLUSION: AS A RESULT OF THE INVESTIGATION, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    IF IMPLANTED; GIVE DATE: ONE YEAR AGO. IF EXPLANTED; GIVE DATE: LENS REMAINS IMPLANTED, THEREFORE NOT EXPLANTED. (B)(6). (B)(4). 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, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT THE SURGEON HAS IMPLANTED A SYMPHONY LENS ONE YEAR AGO AND THE PATIENT REPORTS THAT THE LENS ONLY CORRECTS THE FAR DISTANCE. SHE DOES NOT SEE WELL AT INTERMEDIATE DISTANCE. THE SURGEON COMMENTS THAT THE BEHAVIOUR OF THE LENS IS LIKE A MONOFOCAL. THE LENS REMAINS IMPLANTED. NO ADDITIONAL INFORMATION WAS PROVIDED. PATIENT HAS BILATERAL LENS IMPLANTS. THIS REPORT REPRESENTS THE SECOND OF THE TWO LENS IMPLANTS. A SEPARATE REPORT WILL BE FILED FOR THE FIRST LENS IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1169728 TECNIS SYMFONY MULTIFOCAL IOLS POE JOHNSON & JOHNSON SURGICAL VISION, INC. ZXR00 05050474575707

    Patients

    Seq Age Sex Outcome Treatment
    1 Other