BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS ITEC PRELOADED 1-PIECE IOL

    MDR report key: 10989733 · Received December 11, 2020

    Report

    Report Number
    2648035-2020-00927
    Event Type
    Malfunction
    Date Received
    December 11, 2020
    Date of Event
    November 10, 2020
    Report Date
    March 31, 2021
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    HQL
    UDI-DI
    05050474620025
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: SECTION D10: DEVICE AVAILABLE FOR EVALUATION: YES. DATE RETURNED TO MANUFACTURER: 15 FEB, 2021. SECTION H3: DEVICE RETURNED TO MANUFACTURER: YES. DEVICE EVALUATION: THE DEVICE WAS RETURNED IN A PLASTIC BAG WITH A SAMPLE CONTAINER THAT CONTAINED FOREIGN MATERIAL INSIDE. DURING EVALUATION OF THE DEVICE THE PLUNGER WAS OBSERVED IN A FULLY ADVANCED POSITION. ALL THE COMPONENTS WERE CORRECTLY ENGAGED TO THE DEVICE. NO DAMAGED AND/ OR DEFECT RELATED TO MANUFACTURING PROCESS WAS IDENTIFIED. TRACES OF LUBRICATING MATERIAL WERE OBSERVED IN THE DEVICE. NO LENS WAS RETURNED FOR EVALUATION. THE FOREIGN MATERIAL WAS SENT TO AN EXTERNAL LABORATORY FOR FURTHER ANALYSIS. THE FOREIGN MATERIAL SAMPLE FORWARDED TO EAG LAB AND WAS ANALYZED BY FOURIER TRANSFORM INFRARED (FTIR) SPECTROSCOPY WITH A PERKINELMER SPECTRUM 200 FTIR SPECTROMETER USING HORIZONTAL ATTENUATED TOTAL REFLECTANCE (HATR) SAMPLING MODE. PERKINELMER SPECTRUMIR SOFTWARE AND BIORAD KNOW IT ALL INFORMATICS SYSTEM 8.0.2 SOFTWARE WERE USED TO PERFORM DATA ANALYSIS. FTIR ANALYSIS OF THE FOREIGN MATERIAL SHOWS THAT IT IS CONSISTENT WITH ABS (ACRYLONITRILE/BUTADIENE/STYRENE). BASED ON THE EAG LAB. ANALYSIS RESULTS THE REPORTED ISSUE WAS VERIFIED. THERE IS AN INDICATION OF A PRODUCT MALFUNCTION, HOWEVER, THE UNIT WAS MANUFACTURED PRIOR TO THE INITIATION OF (B)(4) WHICH ADDRESSED THE CORRECTIONS FOR A SIMILAR EVENT. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: THE PRODUCT TESTING COULD NOT BE PERFORMED, SINCE THE PRODUCT REMAINS IMPLANTED. AND NOT RETURNED FOR EVALUATION. THE REPORTED COMPLAINT CANNOT BE CONFIRMED. MANUFACTURING RECORDS REVIEW: THE MANUFACTURING RECORDS FOR THE DEVICE WERE REVIEWED. THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATION. A SEARCH IN COMPLAINT SYSTEM REVEALED, NO ADDITIONAL COMPLAINT FOLDER HAS BEEN RECEIVED FOR THIS PRODUCTION ORDER NUMBER. CONCLUSION: 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.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT HARD PLASTIC/FOREIGN BODY WAS OBSERVED TO BE FLOATING IN ANTERIOR CHAMBER AFTER THE INTRAOCULAR LENS (IOL) WAS FULLY IMPLANTED. THEY NOTED THE FOREIGN MATERIAL COMING OUT WITH THE LENS DURING IMPLANTATION. THE FOREIGN BODY WAS REMOVED BY THE SURGEON THROUGH CAPSULORHEXIS IMMEDIATELY AFTER INSERTION OF LENS. THERE WAS NO INCISION ENLARGEMENT OR VITRECTOMY PERFORMED AND NO SUTURES WERE REQUIRED. THERE WAS NO MEDICATION INTERVENTION. THERE WAS NO PATIENT INJURY REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1457507 TECNIS ITEC PRELOADED 1-PIECE IOL MONOFOCAL IOLS HQL JOHNSON & JOHNSON SURGICAL VISION, INC. PCB00 05050474620025

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR