BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS SYMFONY

    MDR report key: 5890647 · Received August 19, 2016

    Report

    Report Number
    9614546-2016-00399
    Event Type
    Malfunction
    Date Received
    August 19, 2016
    Date of Event
    July 29, 2016
    Report Date
    May 11, 2017
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    POE
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE INTRAOCULAR LENS (IOL) WAS RETURNED AT THE MANUFACTURING SITE FOR EVALUATION. VISUAL INSPECTION USING A 12X MICROSCOPE MAGNIFICATION SHOWED AN UNKNOWN DRIED SUBSTANCE ON THE LENS. THE LENS WAS CLEANED USING A DETERGENT, PURIFIED WATER AND A SWAB. AFTER CLEANING, THE LENS WAS INSPECTED AGAIN UNDER THE MICROSCOPE AND NO ANOMALIES WERE FOUND. INVESTIGATION OF THE RETURN SAMPLE AND THE CONDITION OF THE RETURN SAMPLE DO NOT SUGGEST THE CONTAMINATION BEFORE CLEANING WAS INTRODUCED DURING MANUFACTURING. MANUFACTURING RECORDS REVIEW: THE MANUFACTURING RECORDS FOR THE INTRAOCULAR LENS WERE REVIEWED. 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) WERE REVIEWED. THE DIRECTIONS FOR USE (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.

    Additional Manufacturer Narrative · 1

    CORRECTED DATA: IN THE INITIAL REPORT THE PRODUCT CODE WAS INCORRECTLY IDENTIFIED AS MFK. THE CORRECT CODE IS POE.

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6). ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A WHITE PLAQUE WAS OBSERVED INSIDE THE MATERIAL OF AN INTRAOCULAR LENS. THE LENS WAS NOT IMPLANTED. NO PATIENT INJURY WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    541829 TECNIS SYMFONY MULTIFOCAL IOLS POE ABBOTT MEDICAL OPTICS ZXR00

    Patients

    Seq Age Sex Outcome Treatment
    1