BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS 1 MULTIFOCAL

    MDR report key: 3834047 · Received May 27, 2014

    Report

    Report Number
    9614546-2014-00139
    Event Type
    Injury
    Date Received
    May 27, 2014
    Date of Event
    May 14, 2014
    Report Date
    May 13, 2014
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    MFK
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT DATE: SHOULD HAVE BEEN (B)(6) 2012 (NOT 2014). ALL PERTINENT INFORMATION AVAILABLE TO THE MANUFACTURER HAS BEEN SUBMITTED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    ALL PERTINENT INFORMATION AVAILABLE TO THE MANUFACTURER HAS BEEN SUBMITTED. PLACEHOLDER.

    Description of Event or Problem · 1

    WE RECEIVED A REPORT THAT A PATIENT ''SUFFERS'' FROM HALOS AND GLARE SINCE BEING IMPLANTED WITH A MULTIFOCAL INTRAOCULAR LENS (IOL). THE DYSPHTOPSIA SIGNIFICANTLY AFFECT HER DAILY ACTIVITIES. THE PATIENT WANTS THE INTRAOCULAR LENS (IOL) EXPLANTED, HOWEVER, THE PROCEDURE HAS NOT BEEN SCHEDULED. THIS MDR IS FOR THE RIGHT EYE. THE DOCTOR ATTRIBUTES THE PATIENT'S SYMPTOMS TO THE IOL. A SEPARATE MDR IS FILED FOR THE PATIENT'S LEFT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310841 TECNIS 1 MULTIFOCAL MULTIFOCAL IOLS MFK ABBOTT MEDICAL OPTICS ZMB00

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other