BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS 1 MULTIFOCAL

    MDR report key: 2861749 · Received December 7, 2012

    Report

    Report Number
    9614546-2012-00198
    Event Type
    Injury
    Date Received
    December 7, 2012
    Date of Event
    September 20, 2012
    Report Date
    November 16, 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). MANUFACTURING RECORD REVIEW INDICATED THERE WERE NO DEVIATIONS REGARDING THE STERILIZATION PROCESS, AND NO DEVIATIONS REGARDING THE STERILITY TEST RESULTS. THE BATCH HAS PASSED ALL ACCEPTANCE CRITERIA FOR ALL TESTS PERFORMED AND IS WITHIN ALL SPECIFICATIONS. PRIOR TO RELEASE TO MARKET THE INTRAOCULAR LENS MET ALL MANUFACTURING SPECIFICATIONS. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    THE INTRAOCULAR LENS WAS RETURNED TO THE MANUFACTURER. VISUAL INSPECTION SHOWED THE OPTIC HAD BEEN CUT IN HALF WHICH IS CONSISTENT WITH A LENS THAT HAS BEEN REMOVED FROM THE EYE; NO OPTICAL DEVIATIONS ON THE OPTIC PARTS COULD BE FOUND. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED HYPEROPIA AND UNDERWENT A REMOVAL AND EXCHANGE OF AN INTRAOCULAR LENS (IOL) DUE TO UNEXPECTED POST OPERATIVE REFRACTION. IT WAS STATED THAT THERE WERE NO COMPLICATIONS, AND NO INCISION ENLARGEMENT WAS MADE. PATIENT WAS STATED TO BE DOING WELL. NO ADDITIONAL INFORMATION WAS PROVIDED.

    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 78 YR Required Intervention