BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS 1 MULTIFOCAL

    MDR report key: 8867920 · Received August 7, 2019

    Report

    Report Number
    9614546-2019-00696
    Event Type
    Malfunction
    Date Received
    August 7, 2019
    Report Date
    November 11, 2020
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    MFK
    UDI-DI
    05050474559509
    PMA / PMN Number
    P980040
    Product Problem
    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 · 0

    SECTION D10: DEVICE AVAILABLE FOR EVALUATION ¿ YES, RETURNED TO MANUFACTURER ON 7/30/2019. SECTION H3: DEVICE RETURNED TO MANUFACTURER ¿ YES. DEVICE EVALUATION: THE PRODUCT WAS RECEIVED IN A DAISYWHEEL. THE PRODUCT WAS INSPECTED BY A QUALIFIED INSPECTOR USING A 12X MAGNIFICATION. IT CAN BE SEEN THAT THE LENS IS CONTAMINATED, DUST PARTICLES ARE PRESENT. THIS IS EXPECTED AS THE LENS WAS TRANSPORTED FROM CONTROLLED ENVIRONMENT DURING MANUFACTURING TO A NON-STERILE, NON-ENVIRONMENTAL CONTROLLED AREA. THE REPORTED FOREIGN MATTER WAS IDENTIFIED STUCK TO A DRIED UP LIQUID COVERING PARTS OF THE OPTICAL PART OF THE IOL. THE COMPLAINT CAN BE CONFIRMED. THE FOREIGN MATTER WAS INVESTIGATED WITH FTIR ANALYSIS, AFTER WHICH THE OBTAINED SPECTRUM WAS COMPARED TO DATABASE SPECTRA FROM KNOWN MATERIALS USED DURING MANUFACTURING. THE COMPOSITION OF THE FOREIGN MATTER WAS FOUND TO BE POLYPROPYLENE, ISOTACTIC. THIS MATCHES THE COMPOSITION OF THE MATERIAL USED FOR LENS INSERT OF SOFT ACRULIC LENSES. BASED ON THE CONDITION OF THE RETURN SAMPLE IT CANNOT BE CONFIRMED THAT THE FOREIGN MATTER WAS INTRODUCED DURING MANUFACTURING. A PRODUCT DEFICIENCY CANNOT BE CONFIRMED. MANUFACTURING RECORDS REVIEW: THE MANUFACTURING RECORDS FOR THE PRODUCT WERE REVIEWED. THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATION. A SEARCH REVEALED THAT NO SIMILAR COMPLAINTS WERE RECEIVED FOR THIS PRODUCTION ORDER NUMBER. 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

    DATE OF EVENT: UNKNOWN, INFORMATION NOT PROVIDED. IF IMPLANTED, GIVE DATE: NOT APPLICABLE, AS LENS WAS NOT IMPLANTED. IF EXPLANTED, GIVE DATE: NOT APPLICABLE, AS LENS WAS NOT IMPLANTED. THEREFORE, NOT EXPLANTED. (B)(4). ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE INTRAOCULAR LENS (IOL), MODEL ZLB00 CASE WAS OPENED A LARGE SIZE FOREIGN MATTER WAS OBSERVED ADHERING TO THE OPTICAL PART OF THE LENS. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A BACK UP LENS. THERE WAS NO PATIENT INJURY REPORTED. NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663918 TECNIS 1 MULTIFOCAL MULTIFOCAL IOLS MFK JOHNSON & JOHNSON SURGICAL VISION, INC. ZLB00 05050474559509

    Patients

    Seq Age Sex Outcome Treatment
    1