BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS OPTIBLUE ITEC PRELOADED 1-PIECE IOL

    MDR report key: 7346187 · Received March 16, 2018

    Report

    Report Number
    2648035-2018-00392
    Event Type
    Injury
    Date Received
    March 16, 2018
    Date of Event
    February 16, 2018
    Report Date
    April 24, 2018
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    HQL
    UDI-DI
    05050474561830
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE AVAILABLE FOR EVALUATION: YES. RETURNED TO MANUFACTURER ON: 03/02/2018. DEVICE RETURNED TO MANUFACTURER: YES. DEVICE EVALUATION: THE LENS REMAINS IMPLANTED, HOWEVER A SAMPLE WAS RECEIVED IN A PLASTIC BAG. THE DEBRIS/PARTICLE IN QUESTION WAS RETURNED IN A PLASTIC COLLECTION CONTAINER. VISUAL INSPECTION USING MICROSCOPE MAGNIFICATION WAS PERFORMED. A WHITE PARTICLE WAS OBSERVED. THE REPORTED ISSUE WAS VERIFIED ON THE RETURN. LABORATORY ANALYSIS RESULTS AND THE SUBJECT MATTER EXPERT (SME) EVALUATION THE FOREIGN MATER IS CONSISTENT WITH ABS (ACRYLONITRILE/BUTADIENE/STYRENE). THE FOREIGN MATERIAL WAS ANALYZED BY FOURIER TRANSFORM INFRARED (FTIR) SPECTROSCOPY WITH A PERKINELMER SPECTRUM 200 FTIR SPECTROMETER USING HORIZONTAL ATTENUATED TOTAL REFLECTANCE (HATR) SAMPLING MODE. THE MANUFACTURING DATA CONFIRMS NO PROCESS DEVIATIONS THAT MAY LEAD TO VISIBLE DEBRIS/PARTICLE DEPOSITION ON THE IOL THAT MAY BE UNDETECTED BY OUR CONTROL PROCESS. 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. BASED ON THE MANUFACTURING RECORDS REVIEW, HISTORICAL COMPLAINT REVIEW AND NON-CONFORMANCE/CAPA REVIEW, WE COULD NOT DETERMINE A PRODUCT MALFUNCTION OR A PRODUCT QUALITY DEFICIENCY. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    THE LENS REMAINS IMPLANTED. THIS REPORT IS BEING FILED ON AN INTERNATIONAL DEVICE; TECNIS OPTIBLUE 1-PIECE IOL, THAT HAS A SIMILAR DEVICE, TECNIS 1-PIECE IOL MODEL PCB00 WHICH IS DISTRIBUTED IN THE UNITES STATES UNDER PMA P980040. (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 WHITE FOREIGN MATERIAL WAS FOUND IN THE EYE AFTER INSERTING A PCB00V 23.5 DIOPTER INTRAOCULAR LENS (IOL) DURING IRRIGATION AND ASPIRATION. AN ATTEMPT TO REMOVE THE FOREIGN MATERIAL VIA IA WAS UNSUCCESSFUL, AS IT WAS TOO LARGE TO BE SUCKED OUT. THE FOREIGN MATERIAL WAS EVENTUALLY REMOVED FROM THE SIDE PORT USING FORCEPS. THE LENS REMAINS IMPLANTED IN THE PATIENT'S OPERATIVE EYE AND THE PATIENT HAS BEEN UNDER OBSERVATION. THE PROCEDURE WAS EXTENDED FOR 10 MINUTES. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    189859 TECNIS OPTIBLUE ITEC PRELOADED 1-PIECE IOL MONOFOCAL IOLS HQL JOHNSON & JOHNSON SURGICAL VISION, INC. PCB00V 05050474561830

    Patients

    Seq Age Sex Outcome Treatment
    1