BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS SYMFONY OPTIBLUE

    MDR report key: 6709754 · Received July 12, 2017

    Report

    Report Number
    9614546-2017-00610
    Event Type
    Malfunction
    Date Received
    July 12, 2017
    Date of Event
    June 21, 2017
    Report Date
    November 30, 2017
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    POE
    UDI-DI
    05050474610156
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON FURTHER REVIEW OF THIS EVENT IT WAS FOUND THAT BASED ON THE ANALYSIS OF THE RETURNED SAMPLE, THERE IS AN INDICATION OF A PRODUCT MALFUNCTION OR PRODUCT QUALITY DEFICIENCY. CONSIDERING THIS CONCLUSION, AN INVESTIGATION WAS INITIATED TO FURTHER EVALUATE THIS EVENT. THE COMPLAINT WAS CONFIRMED. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    NO PATIENT INVOLVEMENT REPORTED. (B)(6). THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, INTRAOCULAR LENS (IOL) MODEL NUMBER ZXR00V THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE UNITED STATES, IOL MODEL NO. ZXR00, 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 08/03/2017. DEVICE RETURNED TO MANUFACTURER?: YES. DEVICE EVALUATION: THE INTRAOCULAR LENS (IOL) WAS RETURNED TO THE MANUFACTURING SITE FOR EVALUATION. VISUAL EXAMINATION REVEALED THREE SMALL PIECES OF WHITE PARTICLE DEBRIS ON THE OPTIC SURFACE. A PHOTOGRAPH WHICH ACCOMPANIED THE SAMPLE CLEARLY IDENTIFIED THE LOCATION AND MATERIAL OF INTEREST. THE DEBRIS WAS REMOVED AND AN FTIR(FOURIER TRANSFORM INFARED) SPECTRUM WAS OBTAINED OF EACH PARTICLE. THE WHITE PARTICLE DEBRIS ON THE IOL SURFACE IS CONSISTENT WITH POLYCARBONATE. POLYCARBONATE IS USED AS PACKAGING MATERIAL. THE LENS CASE IS MADE OUT OF POLYCARBONATE. INVESTIGATION OF THE RETURN SAMPLE SHOWS THE LENS CASE IS DAMAGED. 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 SIMILAR 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. 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 UPON OPENING THE LENS CASE OF AN INTRAOCULAR LENS (IOL), THE SURGEON OBSERVED, UNDER THE MICROSCOPE, A SMALL WHITE THIN SUBSTANCE (ABOUT 0.5MM SIZE) ON THE EDGE PART OF THE OPTIC. REPORTEDLY, THE LENS WAS NOT USED. NO PATIENT INVOLVEMENT WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    490006 TECNIS SYMFONY OPTIBLUE MULTIFOCAL IOLS POE ABBOTT MEDICAL OPTICS ZXR00V 05050474610156

    Patients

    Seq Age Sex Outcome Treatment
    1