BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS 1 MULTIFOCAL

    MDR report key: 8602164 · Received May 10, 2019

    Report

    Report Number
    9614546-2019-00447
    Event Type
    Injury
    Date Received
    May 10, 2019
    Report Date
    November 11, 2020
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    MFK
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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

    DATE OF EVENT: UNKNOWN, NOT PROVIDED, BUT THE BEST ESTIMATE DATE IS (B)(6) 2019. EXPIRATION DATE: UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. SERIAL NUMBER: UNKNOWN, THE SERIAL NUMBER OF THE DEVICE WAS NOT PROVIDED. CATALOG#: A COMPLETE CATALOG# IS UNKNOWN, AS THE SERIAL NUMBER OF THE DEVICE WAS NOT PROVIDED. UDI NUMBER: ONLY A PARTIAL UDI NUMBER IS KNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. IF EXPLANTED, GIVE DATE: NOT APPLICABLE, AS THERE IS NO INDICATION THAT THE LENS WAS EXPLANTED. (B)(6). DEVICE MANUFACTURE DATE: UNKNOWN AS SERIAL NUMBER WAS NOT PROVIDED. DEVICE EVALUATION: THE PRODUCT TESTING COULD NOT BE PERFORMED AS THE PRODUCT WAS NOT RETURNED; LENS REMAINS IMPLANTED. THE CUSTOMER'S REPORTED COMPLAINT COULD NOT BE VERIFIED. MANUFACTURING RECORD REVIEW: A MANUFACTURING RECORD REVIEW COULD NOT BE PERFORMED AS A SERIAL NUMBER WAS NOT PROVIDED. LABELING REVIEW: THE DIRECTIONS FOR USE (DFU) WERE REVIEWED. THE DFU ADEQUATELY PROVIDES INSTRUCTIONS AND PRECAUTIONS, ALONG WITH WARNINGS FOR THE PROPER USE AND HANDLING OF THE PRODUCT. CONCLUSION: 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SYMPTOMS SUSPECTED OF ENDOPHTHALMITIS WERE IDENTIFIED. THE EYE WAS WASHED AND OBSERVED. ADDITIONAL INFORMATION STATES THE ANTERIOR CHAMBER OF THE EYE WAS CLEANED AND WASHED WITH RINDERON, A STEROIDAL ANTI-INFLAMMATORY DRUG. CURRENT VISUAL ACUITY WAS 0.7. NO OTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    395019 TECNIS 1 MULTIFOCAL MULTIFOCAL IOLS MFK JOHNSON & JOHNSON SURGICAL VISION, INC. ZLB00

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention