BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS CL

    MDR report key: 8774464 · Received July 10, 2019

    Report

    Report Number
    2648035-2019-00711
    Event Type
    Malfunction
    Date Received
    July 10, 2019
    Date of Event
    June 4, 2019
    Report Date
    November 12, 2020
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    HQL
    UDI-DI
    05050474530652
    PMA / PMN Number
    P880081
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    IN THE INITIAL MDR CONCLUSION CODE WAS INADVERTENTLY NOT POPULATED WITH CODE 67. DEVICE AVAILABLE FOR EVALUATION? YES, RETURNED TO MANUFACTURER ON: 07/08/2019. DEVICE RETURNED TO MANUFACTURER: YES. DEVICE EVALUATION: THE SAMPLE WAS EVALUATED, AND THE LENS WAS OBSERVED WITH RESIDUES THAT LOOKS LIKE BODY FLUIDS ON THE LENS RELATED TO THE HANDLING OF THE UNIT IN A SURGICAL PROCEDURE. LOOSE FIBERS/PARTICLES WERE OBSERVED ON LENS RELATED TO THE HANDLING OF THE UNIT OUT OF A STERILE ENVIRONMENT. ONE HAPTIC WAS ALSO OBSERVED DISTORTED. BASED ON THE EVIDENCE OBSERVED, IT IS NOT POSSIBLE TO CONFIRM IF THE PARTICLES OBSERVED IS RELATED TO MANUFACTURING, AS THE REPORTED LENS WAS HANDLING AND PREPARED FOR SURGICAL PROCEDURE. MANUFACTURING RECORD REVIEW: THE MANUFACTURING RECORDS FOR THE INTRAOCULAR LENS WERE REVIEWED. THE PRODUCT WAS MANUFACTURED ACCORDING TO SPECIFICATIONS. THE SEARCH REVEALED THAT NO OTHER COMPLAINT FOR THIS PRODUCTION ORDER NUMBER HAS BEEN RECEIVED. 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 (B)(4) AND CAPA-010215.

    Additional Manufacturer Narrative · 1

    IF IMPLANTED, GIVE DATE: NOT APPLICABLE, AS THE LENS WAS NOT IMPLANTED. IF EXPLANTED, GIVE DATE: NOT APPLICABLE, AS THE LENS WAS NOT IMPLANTED; THEREFORE, IT WAS NOT EXPLANTED. EMAIL ADDRESS: UNKNOWN, INFORMATION NOT PROVIDED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS SOME TYPE OF DEBRIS/PARTICLE ON A INTRAOCULAR LENS (IOL) PRIOR TO LOADING. THERE WAS NO PATIENT CONTACT REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    568854 TECNIS CL MONOFOCAL IOLS HQL JOHNSON & JOHNSON SURGICAL VISION, INC. Z9002 05050474530652

    Patients

    Seq Age Sex Outcome Treatment
    1