BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS 1-PIECE

    MDR report key: 6730885 · Received July 21, 2017

    Report

    Report Number
    3011852734-2017-00011
    Event Type
    Malfunction
    Date Received
    July 21, 2017
    Date of Event
    June 28, 2017
    Report Date
    September 22, 2017
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    UDI-DI
    05050474531802
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE AVAILABLE FOR EVALUATION? YES, RETURNED TO MANUFACTURER ON 8/8/2017. DEVICE RETURNED TO MANUFACTURER? YES. THE PRODUCT WAS RECEIVED IN AN UNOPENED INNER POUCH OF THE ORIGINAL PACKAGING. VISUAL INSPECTION SHOWS THAT THE BLACK PARTICLE WAS OBSERVED BEHIND THE DAISY WHEEL IN THE UNOPENED INNER POUCH. THE BLACK PARTICLE WITH A SIZE 4MM WIDTH AND 3MM LONG IS A LOOSE PARTICLE AND IS NOT EMBEDDED. THE BLACK PARTICLE WAS SENT FOR FOURIER TRANSFORM INFRARED, FTIR TESTING. THE RESULT SHOW THAT THE CLOSEST MATCHING FOR THIS SAMPLE IS POLY(STYRENE-CO-ACRYLONITRILE) 25 WT. % ACRYLONITRILE WITH 89.1%. THIS POLY(STYRENE-CO-ACRYLONITRILE) 25 WT. % ACRYLONITRILE IS GENERAL COMPONENT WHICH CAN NORMALLY BE FOUND IN FOOD CONTAINERS, KITCHENWARE, COMPUTER PRODUCTS, PACKAGING MATERIAL, BATTERY CASES AND PLASTIC OPTICAL FIBERS. IT IS STRUCTURALLY RELATED TO ABS PLASTIC (ACRYLONITRILE/BUTADIENE/STYRENE). THE INVESTIGATION WAS UNABLE TO DETERMINE THE SOURCE OF THIS PARTICLE. THE COMPLAINT IS CONFIRMED AS THERE IS BLACK PARTICLE INSIDE AN UNOPENED INNER POUCH AND A PRODUCT DEFICIENCY. THE MANUFACTURING RECORDS FOR THE PRODUCT WERE REVIEWED. THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATIONS. A SEARCH REVEALED THAT NO ADDITIONAL COMPLAINTS FOR THIS ORDER NUMBER HAVE BEEN RECEIVED. THE DIRECTIONS FOR USE (DFU) WERE REVIEWED. THE DFU PROVIDE THE CUSTOMER WITH PROPER USAGE INSTRUCTIONS AND GUIDELINES. AS A RESULT OF THE INVESTIGATION, THERE IS AN INDICATION OF A PRODUCT QUALITY DEFICIENCY. THE CUSTOMER'S REPORTED EVENT WAS VERIFIED. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    THE INTRAOCULAR LENS WAS NOT IMPLANTED. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A SPECK OF MATERIAL NOTED IN THE INTRAOCULAR LENS (IOL) CASE WITH THE IOL. NO ADDITIONAL INFORMATION WAS PROVIDED TO ABBOTT MEDICAL OPTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    513719 TECNIS 1-PIECE MONOFOCAL IOLS HQL ABBOTT MEDICAL OPTICS ZCB00 05050474531802

    Patients

    Seq Age Sex Outcome Treatment
    1