BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS 1 MULTIFOCAL

    MDR report key: 4142512 · Received October 6, 2014

    Report

    Report Number
    9614546-2014-00234
    Event Type
    Injury
    Date Received
    October 6, 2014
    Date of Event
    August 27, 2014
    Report Date
    September 10, 2014
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    MFK
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED. PLACEHOLDER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN INTRAOCULAR LENS WAS EXPLANTED IN A SECONDARY PROCEDURE FROM THE LEFT EYE OF A PATIENT DUE TO MYOPIC OUTCOME FROM THE FIRST PROCEDURE. THERE WAS NO INCISION ENLARGEMENT AND NO VITRECTOMY PERFORMED. NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    624157 TECNIS 1 MULTIFOCAL MULTIFOCAL IOLS MFK ABBOTT MEDICAL OPTICS ZMB00

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention