BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS SYMFONY

    MDR report key: 6488325 · Received April 12, 2017

    Report

    Report Number
    9614546-2017-00298
    Event Type
    Injury
    Date Received
    April 12, 2017
    Date of Event
    February 7, 2017
    Report Date
    July 17, 2017
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    POE
    UDI-DI
    05050474579071
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE AVAILABLE FOR EVALUATION ¿ YES, RETURNED TO MANUFACTURER ON 4/21/2017. DEVICE RETURNED TO MANUFACTURER ¿ YES. DEVICE EVALUATION: THE DEVICE WAS RETURNED TO THE MANUFACTURER. VISUAL INSPECTION WITH THE UNAIDED EYE SHOWS THE PRODUCT IS CUT IN PIECES, MOST PROBABLY TO MAKE EXPLANT POSSIBLE. CONSIDERING THE CONDITION OF THE LENS ADDITIONAL ANALYSIS IS NOT POSSIBLE. THE CUSTOMER'S REPORTED COMPLAINT CANNOT BE CONFIRMED. MANUFACTURING RECORDS WERE REVIEWED AND THE LENS WAS MANUFACTURED ACCORDING TO SPECIFICATION. A SEARCH ON COMPLAINTS REVEALED NO SIMILAR COMPLAINTS WERE RECEIVED FOR THIS ORDER NUMBER TO DATE. THE DIRECTIONS FOR USE (DFU) WAS REVIEWED. THE DFU ADEQUATELY PROVIDES INSTRUCTIONS AND PRECAUTIONS FOR THE PROPER USE AND HANDLING OF THE DEVICE. BASED ON THE INVESTIGATION RESULTS THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. ALL PERTINENT INFORMATION AVAILABLE TO THE MANUFACTURER 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). ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT PRESENTED WITH MIDLY MYOPIC UNCORRECTED REFRACTIVE ERROR IN LEFT EYE POST TREATMENT. EXPLANT WAS DONE. NO VITRECOMY OR WOUND ENLARGEMENT WAS REQUIRED. THE REPLACEMENT LENS USED WAS A Z9002. THERE WAS NO PATIENT INJURY, AND THE PATIENT IS DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270219 TECNIS SYMFONY MULTIFOCAL IOLS POE ABBOTT MEDICAL OPTICS ZXR00 05050474579071

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention