BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS 1 MULTIFOCAL

    MDR report key: 8576048 · Received May 2, 2019

    Report

    Report Number
    2648035-2019-00526
    Event Type
    Injury
    Date Received
    May 2, 2019
    Report Date
    November 11, 2020
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    MFK
    UDI-DI
    05050474535442
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    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-(B)(4) AND CAPA-010215.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: EXACT DATE OF EVENT IS UNKNOWN BEST ESTIMATE IS BETWEEN (B)(6) 2019. (B)(4). ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    DEVICE AVAILABLE FOR EVALUATION; RETURNED TO MANUFACTURER ON: 05/06/2019. DEVICE EVALUATION: THE INTRAOCULAR LENS WAS RECEIVED IN A PLASTIC BAG ON MAY 06, 2019. THE LENS AND ONE HAPTIC WAS OBSERVED DAMAGED WITH RESIDUE THAT LOOKED LIKE BODY FLUIDS ON THE LENS RELATED TO THE HANDLING OF THE UNIT IN A SURGICAL PROCEDURE. THE CONDITION OBSERVED IS CONSISTENT WITH A LENS THAT HAS BEEN EXPLANTED. THE REPORTED ISSUE OF DISSATISFACTION COULD NOT BE CONFIRMED. BASED ON THE PRODUCT RETURNED EVALUATION, A PRODUCT QUALITY DEFICIENCY OR PRODUCT MALFUNCTION COULD NOT BE DETERMINED. MANUFACTURING RECORDS REVIEW: THE MANUFACTURING RECORDS FOR THE INTRAOCULAR LENS WERE REVIEWED. THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATION. A SEARCH ON COMPLAINTS REVEALED THAT NO OTHER COMPLAINTS WERE RECEIVED FOR THIS PRODUCTION ORDER NUMBER. LABELING REVIEW: THE DIRECTIONS FOR USE (DFU) WAS REVIEWED. THE DFU ADEQUATELY PROVIDES INSTRUCTIONS AND PRECAUTIONS ALONG WITH WARNINGS FOR THE PROPER USE AND HANDLING OF THE DEVICE. 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 THE INTRAOCULAR LENS (IOL) WAS EXPLANTED DUE TO THE PATIENT NOT BEING HAPPY WITH THEIR INTERMEDIATE VISION IN THE LEFT EYE WITH THEIR MULTIFOCAL LENS. THE LENS WAS REPLACED WITH A SYMFONY LENS, AND THE PATIENT WAS REPORTED AS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    367431 TECNIS 1 MULTIFOCAL MULTIFOCAL IOLS MFK JOHNSON & JOHNSON SURGICAL VISION, INC. ZMB00 05050474535442

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention