BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS MULTIFOCAL

    MDR report key: 2101368 · Received May 24, 2011

    Report

    Report Number
    9614546-2011-00034
    Event Type
    Injury
    Date Received
    May 24, 2011
    Date of Event
    April 18, 2011
    Report Date
    April 25, 2011
    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

    THE INTRAOCULAR LENS (IOL) WAS RECEIVED IN A CONDITION THAT PRECLUDED ANALYSIS . BATCH 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 20.5 DIOPTER OF THIS LOT NUMBER. A REVIEW OF THE HISTORICAL COMPLAINT DATA BASE REVEALED THAT NO OTHER COMPLAINTS FROM THIS LOT NUMBER WERE RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE MULTIFOCAL INTRAOCULAR LENS (IOL) WAS REMOVED AND REPLACED DUE TO IMPROPER IOL POWER. NO INJURY OR ADVERSE EFFECTS TO THE PATIENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention