BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS SYMFONY TORIC

    MDR report key: 5895160 · Received August 22, 2016

    Report

    Report Number
    9614546-2016-00403
    Event Type
    Injury
    Date Received
    August 22, 2016
    Date of Event
    July 7, 2016
    Report Date
    September 26, 2016
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    POE
    UDI-DI
    05050474574656
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE INTRAOCULAR LENS (IOL) WAS NOT RETURNED AT THE MANUFACTURING SITE; THEREFORE PRODUCT TESTING COULD NOT BE PERFORMED AND THE CUSTOMER'S REPORTED COMPLAINT COULD NOT BE VERIFIED. 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 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 AND THE REPORTED ISSUE COULD NOT BE VERIFIED. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    IN THE INITIAL MDR, THE PRODUCT CODE WAS INCORRECTLY PROVIDED AS MFK. PRODUCT CODE: POE (CORRECTED). ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    TO DATE, THE INTRAOCULAR LENS REMAINS IMPLANTED. (B)(6). (B)(4). ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SYMFONY LENS WAS IMPLANTED AND WITHIN THE 2 WEEKS POST OPERATIVE TIME FRAME, THE LENS HAD ROTATED. THE LENS WAS REPOSITIONED IN A SECONDARY PROCEDURE. THE DEGREE OF ROTATION WAS NOT PROVIDED. THE REPOSITION WENT VERY WELL. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    547080 TECNIS SYMFONY TORIC MULTIFOCAL IOLS POE ABBOTT MEDICAL OPTICS ZXT225 05050474574656

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention