BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS MULTIFOCAL

    MDR report key: 1884305 · Received October 27, 2010

    Report

    Report Number
    9614546-2010-00054
    Event Type
    Injury
    Date Received
    October 27, 2010
    Date of Event
    September 27, 2010
    Report Date
    September 28, 2010
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    MFK
    PMA / PMN Number
    P080010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE IOL WAS DISCARDED AT THE SURGERY CENTER AND NOT RETURNED TO THE MANUFACTURER FOR ANALYSIS. SURGEON STATED THE REASON FOR THE EXPLANT WAS THE PATIENT'S INTOLERANCE OF THE MULTIFOCALITY OF THE LENS. HALOS AND GLARE ARE A KNOWN AND LABELED POSSIBLE SIDE EFFECT OF ALL MULTIFOCAL LENS IMPLANTS. MANUFACTURING RECORDS WERE REVIEWED AND SHOWED NO DEVIATIONS. A REVIEW OF COMPLAINT RECORDS REVEALED THAT NO ADDITIONAL COMPLAINTS FROM THIS WORK ORDER WERE RECEIVED. WE HAVE NO REASON TO SUSPECT THIS EVENT IS MANUFACTURING RELATED. DEVICE DISCARDED BY THE SURGERY CENTER.

    Description of Event or Problem · 1

    IT WAS REPORTED THE SURGEON REMOVED THE PATIENT'S MULTIFOCAL INTRAOCULAR LENS 4 MONTHS AFTER IMPLANT DUE TO THE PATIENT'S INTOLERANCE OF THE MULTIFOCALITY. THE INITIAL IMPLANT WAS REPLACED WITH A MONOFOCAL LENS WITHOUT COMPLICATION. THE EXPLANTED LENS WAS DISCARDED BY THE SURGERY CENTER.

    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 Required Intervention