BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS 1 MULTIFOCAL

    MDR report key: 2800080 · Received October 22, 2012

    Report

    Report Number
    9614546-2012-00180
    Event Type
    Injury
    Date Received
    October 22, 2012
    Date of Event
    June 21, 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
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) USED FOR REMOVAL AND REPLACEMENT OF IOL. ALL PERTINENT INFORMATION AVAILABLE TO AMO HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    THE LENS WAS RETURNED TO OUR MANUFACTURING FACILITY FOR EVALUATION. A VISUAL INSPECTION SHOWED A LENS WHERE THE OPTIC WAS CUT IN HALF, NO OPTICAL DEVIATIONS ON THE OPTIC PARTS WERE FOUND. THE LENS PASSED ALL ACCEPTANCE CRITERIA FOR ALL TESTS PERFORMED AND WAS WITHIN ALL SPECIFICATIONS DURING THE MANUFACTURING PROCESS. A REVIEW OF THE MANUFACTURING RECORDS SHOWED NO DEVIATIONS. THE DIOPTER MEASUREMENT RECORDS VERIFIED AND WERE SHOWN TO BE WITHIN SPECIFICATIONS. THIS WAS IN COMPLIANCE WITH THE LABELED DIOPTRIC POWER OF 19.0 DIOPTER FOR THIS LENS. THE BATCH PASSED ALL ACCEPTANCE CRITERIA FOR ALL TESTS PERFORMED AND WAS WITHIN ALL SPECIFICATIONS. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    A SURGERY CENTER REPORTED THAT A FEMALE PATIENT HAD AN INTRAOCULAR LENS (IOL) EXPLANTED AND REPLACED WITH ANOTHER IOL AFTER SHE EXPERIENCED AN HYPEROPIC VISUAL OUTCOME. THE INCISION WAS NOT ENLARGED AND NO PATIENT INJURY WAS 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 63 YR Required Intervention