BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS

    MDR report key: 3884333 · Received June 19, 2014

    Report

    Report Number
    9614546-2014-00161
    Event Type
    Injury
    Date Received
    June 19, 2014
    Date of Event
    May 12, 2014
    Report Date
    June 3, 2014
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    MFK
    PMA / PMN Number
    P080010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT LENS WAS REPLACED WITH ANOTHER ZMA00 16.0 DIOPTER IOL. THE PHYSICIAN SAID THAT AT THE TIME HE REPLACED THE LENS JUST TO BE SAFE BUT ORIGINAL LENS LOOKED FINE AFTER REMOVED. (B)(4). PLACEHOLDER

    Additional Manufacturer Narrative · 1

    (B)(4). ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS AT THE TIME OF THIS REPORT AS BEEN SUBMITTED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A ZMA00 16.0 DIOPTER INTRAOCULAR LENS WAS EXPLANTED FROM THE LEFT EYE OF A MALE PATIENT IN A SECONDARY PROCEDURE. THE PATIENT'S CAPSULAR BAG COULD NOT SUPPORT THE LENS FOR TOO LONG DUE TO PATIENT ANATOMY. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    359928 TECNIS MULTIFOCAL IOLS MFK ABBOTT MEDICAL OPTICS ZMA00

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention