BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS 1-PIECE

    MDR report key: 8602100 · Received May 10, 2019

    Report

    Report Number
    3011852734-2019-00105
    Event Type
    Malfunction
    Date Received
    May 10, 2019
    Date of Event
    March 5, 2019
    Report Date
    November 11, 2020
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    HQL
    UDI-DI
    05050474531741
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: THE PRODUCT WAS RETURNED TO THE MANUFACTURING SITE FOR EVALUATION. VISUAL INSPECTION AT 10X MICROSCOPE MAGNIFICATION SHOWED RETURNED CUT INTO TWO PIECES, MOST PROBABLY TO AID IN REMOVAL. THE LENS PIECES APPEAR TO HAVE TRACES OF BLOOD AS WELL AS WHITE LIQUID OR GEL RESIDUE. THE REPORTED ISSUE IS CONFIRMED, HOWEVER THE CHARACTER OF MATERIAL OR HOW AND WHEN THE MATERIAL WAS DEPOSITED ON THE LENS COULD NOT BE DETERMINED THROUGH PRODUCT INSPECTION. THE PRODUCT WAS FORWARDED TO AN EXTERNAL LAB FOR ADDITIONAL MATERIAL ANALYSIS OF THE OBSERVED RESIDUE. THE RESULTS FOR THE FOURIER TRANSFORM INFRARED (FTIR) SPECTRUM SHOWS THE RESIDUE IS CONSISTENT WITH INORGANIC SALTS SIMILAR TO SODIUM HYALURONATE MANUFACTURING RECORD REVIEW: THE MANUFACTURING RECORDS FOR THE PRODUCT WERE REVIEWED. THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATIONS. A SEARCH REVEALED THAT NO SIMILAR COMPLAINTS WERE RECEIVED FOR THIS PRODUCTION ORDER. CONCLUSION: AS A RESULT OF THE INVESTIGATION THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. 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-0148919 AND CAPA-010215.

    Additional Manufacturer Narrative · 1

    IF IMPLANTED, GIVE DATE: NOT APPLICABLE AS LENS WAS REMOVED/REPLACED IN THE INITIAL SURGERY. IF EXPLANTED, GIVE DATE: NOT APPLICABLE AS LENS WAS REMOVED/REPLACED IN THE INITIAL SURGERY. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IOL MODEL ZCB00 21.5 DIOPTER HAD A GLUE LIKE SUBSTANCE ON THE LENS. THE IOL WAS REMOVED AND REPLACED WITH THE SAME MODEL AND DIOPTER. THERE WERE NO COMPLICATIONS. REPORTEDLY, THE PATIENT IS DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    393863 TECNIS 1-PIECE MONOFOCAL IOLS HQL JOHNSON & JOHNSON SURGICAL VISION, INC. ZCB00 05050474531741

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR