BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS 1 MULTIFOCAL

    MDR report key: 2795193 · Received October 17, 2012

    Report

    Report Number
    9614546-2012-00172
    Event Type
    Injury
    Date Received
    October 17, 2012
    Date of Event
    July 17, 2012
    Report Date
    October 9, 2012
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    MFK
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURING RECORDS REVIEW: THE DEVICE MANUFACTURING RECORDS WERE REVIEWED AND SHOW NO DEVIATIONS. DIOPTER MEASUREMENT RECORDS FROM THIS PARTICULAR LENS WERE VERIFIED AND SHOWED TO BE WITHIN SPECIFICATIONS. THE BATCH PASSED ALL ACCEPTANCE CRITERIA FOR ALL TESTS PERFORMED AND WAS WITHIN ALL SPECIFICATIONS. VISUAL INSPECTION OF THE RETURNED LENS SHOWED THE LENS HAD BEEN CUT IN HALF. NO OPTICAL DEVIATIONS ON THE OPTIC PARTS COULD BE FOUND. CONCLUSION: THE DEVICE PASSED ALL ACCEPTANCE CRITERIA FOR ALL TESTS PERFORMED AND WAS WITHIN ALL SPECIFICATIONS DURING THE MANUFACTURING PROCESS, THEREFORE NO PRODUCTION RELATED CAUSE IS EXPECTED. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS INC HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). ALL PERTINENT INFORMATION AVAILABLE TO AMO HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    WE RECEIVED A REPORT FROM A SURGERY CENTER THAT A FEMALE PATIENT HAD AN INTRAOCULAR LENS (IOL) IMPLANTED IN THE RIGHT EYE ON (B)(6) 2012. THE LENS WAS EXPLANTED WITHOUT AN ENLARGED INCISION ON (B)(6) 2012 DUE TO DYSPHOTOPSIA. THE EVENT WAS NOT DUE TO A USER/HANDLER ERROR. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TECNIS 1 MULTIFOCAL MULTIFOCAL IOLS MFK ABBOTT MEDICAL OPTICS ZMB00

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention