BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS ITEC PRELOADED 1-PIECE IOL

    MDR report key: 7751089 · Received August 6, 2018

    Report

    Report Number
    2648035-2018-01089
    Event Type
    Malfunction
    Date Received
    August 6, 2018
    Date of Event
    July 16, 2018
    Report Date
    November 2, 2020
    Manufacturer
    JOHNSON AND JOHNSON SURGICAL VISION, INC.
    Product Code
    HQL
    UDI-DI
    05050474558335
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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 (B)(4) AND CAPA-010215.

    Additional Manufacturer Narrative · 0

    DEVICE AVAILABLE FOR EVALUATION? YES. RETURNED TO MANUFACTURER ON: 08/25/2018. DEVICE RETURNED TO MANUFACTURER? YES. DEVICE EVALUATION: THE ACTUAL LENS WAS NOT RETURNED AS IT REMAINS IMPLANTED. A HARD PLASTIC SPECIMEN CONTAINER WAS RECEIVED WHICH HAD TWO UNKNOWN BLUE PIECES OF PLASTIC IN IT. THE SAMPLE WAS SENT TO THE LAB FOR FURTHER ANALYSIS. THE VISUAL EXAMINATION OF THE SPECIMEN CONTAINER REVEALED DOZENS OF SMALL PARTICLES AND WHITE FLECKS IN THE CONTAINER. IT WAS IMPOSSIBLE TO KNOW WHICH PARTICLE THE MATERIAL OF INTEREST WAS. HOWEVER, THREE PARTICLES WERE SELECTED AND REMOVED FROM THE SPECIMEN CONTAINER FOR ANALYSIS. THE WHITE DEBRIS REMOVED FROM THE SPECIMEN CONTAINER IS CONSISTENT WITH A FATTY AMIDE (I.E. STEARAMIDE, OLEAMIDE, ERUCAMIDE). THESE TYPES OF AMIDES ARE COMMON ADDITIVES TO PLASTICS AND LUBRICANTS FOR PLASTIC BAGS. THE MANUFACTURING PROCESS IS PERFORMED INSIDE A REGULATED CLEAN ROOM THAT REQUIRES FULL GOWNING BEFORE ENTERING THE ROOM. THE MANUFACTURING CONTROLS ARE CAPABLE OF IDENTIFYING THE PRESENCE OF THIS TYPE OF PARTICULATE DURING THE INSPECTION CONTROLS, AS DEFINED PART OF THE MANUFACTURING PROCESS. THE COMPLAINT ISSUE REPORTED WAS VERIFIED, HOWEVER, IT CANNOT FULLY CONFIRM TO BE RELATED TO THE MANUFACTURING PROCESS, SINCE THE DEVICE WAS HANDLED AND PREPARE FOR SURGICAL PROCESS. MANUFACTURING RECORDS REVIEW: THE MANUFACTURING RECORDS FOR THE INTRAOCULAR LENS WERE REVIEWED. THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATION. HISTORICAL DATA ANALYSIS: A COMPLAINT HISTORY SEARCH PERFORMED IN SEPTEMBER 21, 2018 REVEALED THAT NO ADDITIONAL INVESTIGATIONS FOR THIS PRODUCTION ORDER NUMBER HAVE BEEN RECEIVED. LABELING REVIEW: THE DIRECTIONS FOR USE (DFU) WAS REVIEWED. THE DFU ADEQUATELY PROVIDES INSTRUCTIONS AND PRECAUTIONS FOR THE PROPER USE AND HANDLING OF THE PRODUCT. CONCLUSION: BASED ON THE INVESTIGATION RESULTS 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 · 1

    IF EXPLANTED, GIVE DATE: NOT APPLICABLE AS THE LENS REMAINS IMPLANTED AND THEREFORE NOT EXPLANTED. (B)(6). ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING IMPLANTATION, THERE WAS A SMALL PARTICLE ON THE INTRAOCULAR LENS (IOL) SURFACE WHICH ENTERED THE PATIENT'S OPERATIVE EYE. THERE WAS NO INCISION ENLARGEMENT, NO SUTURES WERE USED, NO VITRECTOMY WAS REQUIRED AND NO PATIENT INJURY OCCURRED. REPORTEDLY, THE PARTICLE WAS REMOVED AND THE LENS REMAINS IMPLANTED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    594479 TECNIS ITEC PRELOADED 1-PIECE IOL MONOFOCAL IOLS HQL JOHNSON AND JOHNSON SURGICAL VISION, INC. PCB00 05050474558335

    Patients

    Seq Age Sex Outcome Treatment
    1