BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS 1 MULTIFOCAL

    MDR report key: 8694388 · Received June 13, 2019

    Report

    Report Number
    9614546-2019-00544
    Event Type
    Injury
    Date Received
    June 13, 2019
    Date of Event
    March 11, 2019
    Report Date
    November 12, 2020
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    MFK
    UDI-DI
    05050474560208
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE AVAILABLE FOR EVALUATION: YES. RETURNED TO MANUFACTURER ON: 7/2/2019. DEVICE RETURNED TO MANUFACTURER: YES. DEVICE EVALUATION: THE INTRAOCULAR LENS (IOL) WAS RETURNED TO THE MANUFACTURING SITE FOR EVALUATION. IT CAN BE SEEN THAT THERE ARE MARKS ON THE OPTIC BODY. INVESTIGATION OF THE RETURN SAMPLE AND THE CONDITION OF THE RETURN SAMPLE DO NOT SUGGEST THE DAMAGE WAS INTRODUCED DURING MANUFACTURING. THE COMPLAINT CANNOT BE CONFIRMED. MANUFACTURING RECORDS REVIEW: THE MANUFACTURING RECORDS FOR THE PRODUCT WAS REVIEWED. THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATION. A SEARCH ON COMPLAINTS REVEALED THAT NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FOR THIS PRODUCTION ORDER NUMBER. AS A RESULT OF THE INVESTIGATION THERE IS NO INDICATION OF A PRODUCT QUALITY 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

    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

    (B)(4). ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) IMPLANTED IN THE PATIENT'S RIGHT EYE SHIFTED, AND THERE WAS A MYOPIC SHIFT. THE IOL WAS EXCHANGED WITH ANOTHER IOL OF THE SAME MODEL BUT .5 DIOPTER LOWER. THE PATIENT IS DOING WELL POST-EXCHANGE. THERE WAS NO ADDITIONAL INTERVENTION REQUIRED. ADDITIONAL INFORMATION REPORTED THE MYOPIC SHIFT WAS A RESULT OF THE LENS SHIFT AND THE PATIENT DID NOT HAVE ANY CONTRIBUTING MEDICAL HISTORY. NO ADDITIONAL INFORMATION WAS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    487780 TECNIS 1 MULTIFOCAL MULTIFOCAL IOLS MFK JOHNSON & JOHNSON SURGICAL VISION, INC. ZKB00 05050474560208

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention