BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS SYMFONY

    MDR report key: 5873316 · Received August 12, 2016

    Report

    Report Number
    9614546-2016-00391
    Event Type
    Injury
    Date Received
    August 12, 2016
    Date of Event
    June 17, 2016
    Report Date
    October 9, 2016
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    MFK
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    CORRECTED DATA: PRODUCTION CODE WAS INCORRECTLY INDICATED ON THE INITIAL REPORT AS MFK. THE CORRECT PRODUCTION CODE IS POE. DEVICE EVALUATION THE LENS WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. VISUAL INSPECTION COULD NOT BE PERFORMED, THEREFORE THE REPORTED COMPLAINT COULD NOT BE VERIFIED. MANUFACTURING RECORDS WERE REVIEWED AND THE LENS WAS MANUFACTURED ACCORDING TO SPECIFICATION. THERE WERE NO NON-CONFORMANCES WITH RESPECT TO THE MANUFACTURING PROCESS. THERE WERE NO ASSOCIATED NONCONFORMITY REPORTS OR DEVIATIONS. THE LENSES WERE RELEASED ACCORDING TO SPECIFICATIONS. THE COMPLAINT HISTORY SEARCH REVEALED NO OTHER COMPLAINTS FOR THIS PRODUCTION ORDER NUMBER HAS BEEN RECEIVED. THE DIRECTIONS FOR USE (DFU) WAS REVIEWED. THE DFU ADEQUATELY PROVIDES INSTRUCTIONS AND PRECAUTIONS FOR THE PROPER USE AND HANDLING OF THE INTRAOCULAR LENSES. BASED ON THE INVESTIGATION RESULTS 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 AT THE FIRST POST-OPERATIVE EXAM, A ZXR00 INTRAOCULAR LENS (IOL) WAS NOTED AS DECENTERED FOR NASAL HEMISPHERE. THERE WAS NO IMPROVEMENT AFTER ONE WEEK AND THE COMPLAINT WAS STRONG FROM THE PATIENT. THE PATIENT WAS SENT AGAIN TO THE SURGICAL CENTER. THE LENS WAS REPOSITIONED, BUT AS IT HAD SOFT DECENTRATION. THE LENS WAS EXPLANTED AND IT WAS REPLACED BY ANOTHER SYMFONY IOL OF THE SAME DIOPTER. THE NEW LENS IS POSITIONED CORRECTLY. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    524243 TECNIS SYMFONY MULTIFOCAL IOLS MFK ABBOTT MEDICAL OPTICS ZXR00

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention