BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS OPTIBLUE ITEC PRELOADED 1-PIECE IOL

    MDR report key: 6695823 · Received July 8, 2017

    Report

    Report Number
    2648035-2017-01231
    Event Type
    Malfunction
    Date Received
    July 8, 2017
    Date of Event
    June 14, 2017
    Report Date
    August 18, 2017
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    UDI-DI
    05050474561717
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IF EXPLANTED, GIVE DATE: NOT APPLICABLE AS THERE IS NO INDICATION THAT THE LENS WAS EXPLANTED. PHONE NUMBER: (B)(6). THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, INTRAOCULAR LENS (IOL) MODEL NUMBER PCB00V THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE UNITED STATES, IOL MODEL NO. PCB00, WHICH FALLS UNDER PMA P980040. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    DEVICE AVAILABLE FOR EVALUATION? YES. RETURNED TO MANUFACTURER ON: 06/22/2017. DEVICE RETURNED TO MANUFACTURER? YES. DEVICE EVALUATION: THE PRELOADED DELIVERY SYSTEM, MODEL PCB00V, WAS RETURNED AT THE MANUFACTURING SITE FOR EVALUATION. VISUAL INSPECTION AT 10X MICROSCOPE MAGNIFICATION SHOWED THAT THE PLUNGER WAS IN A FULLY ADVANCED POSITION AND THE CARTRIDGE CORRECTLY ENGAGED INTO LOWER BODY OF THE PCB00V DEVICE. NO ASSEMBLY ERRORS AND/OR DEFECTS RELATED TO THE MANUFACTURING PROCESS WERE OBSERVED. THE INTRAOCULAR LENS (IOL) WAS NOT RETURNED. A SMALL WHITE PARTICLE WAS ALSO RECEIVED INSIDE A SPECIMEN CONTAINER AND IT WAS ANALYSED USING THE FOURIER TRANSFORM INFRARED (FTIR) SPECTROSCOPY. THE RESULTS REVEALED THAT THE BULK MATERIAL IS ABS (ACRYLONITRILE/BUTADIENE/STYRENE) AND THE BROAD PEAKS IN THE SPECTRUM MAY ALSO INDICATE EXPOSURE TO MOISTURE. THE PLUNGER COMPONENT MATERIAL IS ABS. THE CUSTOMER'S REPORTED COMPLAINT OF DEBRIS WAS VERIFIED. MANUFACTURING RECORDS REVIEW: THE MANUFACTURING RECORDS FOR THE INTRAOCULAR LENS WERE REVIEWED. DURING THE MANUFACTURING PROCESS OF THE PCB00V PRODUCTS, SEVERAL VISUAL INSPECTIONS ARE PERFORMED INCLUDING 100% VERIFICATION AT 10X MAGNIFICATION MICROSCOPE INSIDE A LAMINAR FLOW HOOD FOR COSMETIC DEFECTS (INCLUDING PARTICLES AND FIBERS). IONIZED AIR GUNS ARE USED IN THE MANUFACTURING AREAS TO ENSURE REMOVAL OF ANY LOOSE PARTICLES OR MATERIAL THAT COULD BE INTRODUCED AS PART OF THE PACKAGING PROCESS OF THE PRELOADED COMPONENTS. THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATION. A SEARCH REVEALED THAT NO ADDITIONAL COMPLAINTS FOR THIS ORDER NUMBER HAVE BEEN RECEIVED. LABELING REVIEW: THE DIRECTIONS FOR USE (DFU) ADEQUATELY PROVIDES INSTRUCTIONS AND PRECAUTIONS ALONG WITH WARNINGS FOR THE PROPER USE AND HANDLING OF THE DEVICE. THE DFU STATES TO INSPECT THE DEVICE FOR PARTICLES, MATERIAL DEPOSITS, DAMAGE, OR OTHER DEFECTS. AS A RESULT OF THE INVESTIGATION THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANTATION OF AN INTRAOCULAR LENS (IOL), THE SURGEON OBSERVED SOME DEBRIS BEING INSERTED INTO THE EYE TOGETHER WITH THE IOL. REPORTEDLY, THE SURGEON REMOVED THE DEBRIS DURING THE IRRIGATION/ASPIRATION PROCEDURE. NO PATIENT INJURY WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    476712 TECNIS OPTIBLUE ITEC PRELOADED 1-PIECE IOL MONOFOCAL IOLS HQL ABBOTT MEDICAL OPTICS PCB00V 05050474561717

    Patients

    Seq Age Sex Outcome Treatment
    1