BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS 1 MULTIFOCAL

    MDR report key: 4233402 · Received November 6, 2014

    Report

    Report Number
    9614546-2014-00270
    Event Type
    Injury
    Date Received
    November 6, 2014
    Date of Event
    October 29, 2014
    Report Date
    November 5, 2014
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    MFK
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLETED BY MANUFACTURER. (B)(4) - EXPLANT OF INTRAOCULAR LENS. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    CORRECTED DATA: IF IMPLANTED, GIVE DATE: (B)(6) 2014. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) IMPLANTED IN THE PATIENT'S RIGHT EYE, WAS EXPLANTED IN A SECONDARY PROCEDURE DUE TO ''GLARE WAS TOO MUCH.'' THE PATIENT HAD AN INTRAOCULAR LENS IMPLANTED IN THEIR LEFT EYE THAT HAS BEEN EXPLANTED. THIS EXPLANT FROM THE PATIENT'S LEFT EYE HAS BEEN REPORTED IN A SEPARATE MDR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    712638 TECNIS 1 MULTIFOCAL MULTIFOCAL IOLS MFK ABBOTT MEDICAL OPTICS ZMB00

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention