BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS ITEC PRELOADED 1-PIECE IOL

    MDR report key: 11070816 · Received December 24, 2020

    Report

    Report Number
    2648035-2020-00966
    Event Type
    Malfunction
    Date Received
    December 24, 2020
    Date of Event
    November 19, 2020
    Report Date
    February 18, 2021
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    HQL
    UDI-DI
    05050474558168
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION D10 - DEVICE AVAILABLE FOR EVALUATION? YES. SECTION D10 - RETURNED TO MANUFACTURER ON: 1/10/2021. SECTION H3 - DEVICE EVALUATED BY MANUFACTURER? YES. SECTION H3 - DEVICE RETURNED TO MANUFACTURER? YES. DEVICE EVALUATION: THE DEVICE WAS RETURNED IN ITS ORIGINAL PACKAGING. THE PLUNGER WAS OBSERVED FULLY ADVANCED AND A TWEEZER WITH A PLASTIC CAP ON AND WRAPPED WITH ADHESIVE TAPE WAS ALSO RECEIVED IN THE BOX. THE FOREIGN MATERIAL WAS IN THE TWEEZER TIP, AND IT WAS SENT TO EAG LABORATORIES AS RECEIVED FOR FURTHER ANALYSIS. BASED IN THE EAG LAB. ANALYSIS, THE FOREIGN MATERIAL WAS TRANSFERRED TO AN INFRARED TRANSMITTING SUBSTRATE AND ANALYZED IN TRANSMISSION MODE USING A PERKINELMER SPECTRUM SPOTLIGHT 200 FOURIER TRANSFORM INFRARED (FTIR) SPECTROMETER EQUIPPED WITH A MICROSCOPE. THE ANALYTICAL SPOT SIZE WAS APPROXIMATELY 100 MICRONS X 100 MICRONS. PERKINELMER SPECTRUMIR SOFTWARE WAS USED TO PERFORM DATA ANALYSIS. THE PARTICLE WAS RECEIVED ON THE TIP OF A TWEEZERS WHICH HAD BEEN COVERED WITH A PLASTIC CAP AND SECURED WITH TAPE. PHOTOGRAPHS WHICH ACCOMPANIED THE SAMPLE IDENTIFIED THE MATERIAL OF INTEREST AND ITS LOCATION ON THE TWEEZER TIP. FTIR ANALYSIS INDICATES THAT THE PARTICLE IS CONSISTENT WITH A MIXTURE CONTAINING A FATTY AMIDE/WAX (E.G. STEARAMIDE, OLEAMIDE, ERUCAMIDE) AND SILICONE. THESE TYPES OF WAXES ARE COMMON ADDITIVES TO PLASTICS AND LUBRICANTS FOR PLASTIC BAGS. OUR PRODUCT CAN BE EXPOSE TO DIFFERENT MATERIALS DURING THE MANUFACTURING PROCESS (I.E. PROCESSING AIDS). HOWEVER, THESE TYPES MATERIALS ARE NOT PART OF OUR WORKING MATERIALS AND DOES NOT MATCH WITH ANY OF THE COMPONENT OF THE FINAL PRODUCT. BASED ON THE EVALUATION PERFORMED, THE MANUFACTURING PROCESS HAVE CONTROLS TO IDENTIFY AND DISCARD UNITS WITH THIS TYPE OF ISSUES. ALSO, THE MANUFACTURING RECORD REVIEW AND STERILIZATION RECORD REVIEW SHOW THAT THE PRODUCT WAS MADE AND STERILIZED ACCORDING SPECIFICATION AND PARAMETERS ESTABLISHED IN THE PROCEDURES. BASED ON THE MANUFACTURING CONTROLS IN-PLACE, EVIDENCE OBSERVED, AND THE BATCH RECORD REVIEWED, THE REPORTED COMPLAINT CANNOT BE CONFIRMED AS MANUFACTURING PROCESS RELATED. MANUFACTURING RECORD EVALUATION: THE MANUFACTURING RECORDS FOR THE INTRAOCULAR LENS WERE REVIEWED. THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATION.  A SEARCH REVEALED THAT NO ADDITIONAL COMPLAINTS FOR THIS ORDER NUMBER HAVE BEEN RECEIVED. 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

    AGE/DATE OF BIRTH: UNKNOWN/ NOT PROVIDED. SEX/GENDER: UNKNOWN/ NOT PROVIDED. IF EXPLANTED; GIVE DATE: LENS REMAINS IMPLANTED. PHONE: (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 AFTER IMPLANTING THE LENS THE SURGEON SAW A PARTICLE. THIS WAS REMOVED AN RETURNED. NO IMPACT ON THE PATIENT WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1537078 TECNIS ITEC PRELOADED 1-PIECE IOL MONOFOCAL IOLS HQL JOHNSON & JOHNSON SURGICAL VISION, INC. PCB00 05050474558168

    Patients

    Seq Age Sex Outcome Treatment
    1