BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS

    MDR report key: 3033876 · Received April 3, 2013

    Report

    Report Number
    9614546-2013-00062
    Event Type
    Injury
    Date Received
    April 3, 2013
    Date of Event
    October 22, 2012
    Report Date
    March 18, 2013
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    MFK
    PMA / PMN Number
    P080010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LENS WAS EXPLANTED DUE TO PATIENT EXPERIENCING DYSPHOTOPSIA IN THE FORM OF SHADOWS. (B)(4). DEVICE EVALUATION: VISUAL INSPECTION SHOWED THAT THE RETURNED SAMPLE WAS COVERED WITH CONTAMINATIONS, NO OPTICAL DEVIATIONS ON THE OPTIC COULD BE FOUND. DIOPTER EVALUATION COULD NOT BE PERFORMED DUE TO THE CONDITION OF THE RETURNED LENS. LENS PASSED ALL ACCEPTANCE CRITERIA FOR ALL TESTS PERFORMED AND IS WITHIN ALL SPECIFICATIONS DURING THE MANUFACTURING PROCESS, THEREFORE, NO PRODUCTION RELATED CAUSE IS EXPECTED. THE DEVICE MANUFACTURING RECORDS WERE REVIEWED AND SHOWED NO DEVIATIONS. DIOPTER MEASUREMENT RECORDS FROM THIS PARTICULAR LENS WAS VERIFIED AND SHOWED TO BE WITHIN SPECIFICATIONS. THIS IS IN COMPLIANCE WITH THE LABELED DIOPTRIC POWER 24.0 DIOPTER OF THIS LOT NUMBER. REVIEW OF THE HISTORICAL COMPLAINT DATA BASE REVEALED THAT NO COMPLAINTS FROM THIS LOT NUMBER WERE RECEIVED. CONCLUSION: THE BATCH HAS PASSED ALL ACCEPTANCE CRITERIA FOR ALL TESTS PERFORMED AND WAS WITHIN ALL SPECIFICATIONS. ALL PERTINENT INFORMATION AVAILABLE TO THE MANUFACTURER HAS BEEN SUBMITTED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    (B)(4). MANUFACTURING RECORD REVIEW REVEALED THE DEVICE MANUFACTURING RECORDS SHOWED NO DEVIATIONS. REVIEW OF THE HISTORICAL COMPLAINT DATA BASE REVEALED THAT NO COMPLAINTS FROM THIS LOT NUMBER WERE RECEIVED. IN CONCLUSION, THE BATCH HAS PASSED ALL ACCEPTANCE CRITERIA FOR ALL TESTS PERFORMED AND IS WITHIN ALL SPECIFICATIONS. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN IMPLANTATION OF AN INTRAOCULAR LENS (IOL) IN THE LEFT OPTIC WHICH WAS REMOVED AND REPLACED IN A SECONDARY PROCEDURE DUE TO UNEXPECTED POST OPERATIVE REFRACTIVE ERROR. PATIENT WAS NOTED TO BEING DOING WELL. NO COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135907 TECNIS MULTIFOCAL IOLS MFK ABBOTT MEDICAL OPTICS ZMA00

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention