BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS

    MDR report key: 3891636 · Received June 24, 2014

    Report

    Report Number
    2648035-2014-00316
    Event Type
    Injury
    Date Received
    June 24, 2014
    Report Date
    May 30, 2014
    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

    FOLLOW UP INFORMATION SHOWED THAT THE INTRAOCULAR LENS (IOL) WAS EXPLANTED BECAUSE THE PATIENT HAD AN UNSATISFACTORY VISUAL OUTCOME. THE IOL WAS DISCARDED AT THE TIME OF THE EXPLANT. (B)(4). ALL PERTINENT INFORMATION AVAILABLE TO THE MANUFACTURER HAS BEENS SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). ALL PERTINENT INFORMATION AVAILABLE TO THE MANUFACTURER HAS BEEN SUBMITTED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    PMA# (B)(4). ALL PERTINENT INFORMATION AVAILABLE TO THE MANUFACTURER HAS BEEN SUBMITTED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    CORRECTED DATA SECTION: PMA P080010. ALL PERTINENT INFORMATION AVAILABLE TO THE MANUFACTURER HAS BEEN SUBMITTED. PLACEHOLDER.

    Description of Event or Problem · 1

    WE RECEIVED A REPORT THAT AN ZMA 23.50 DIOPTER INTRAOCULAR LENS (IOL) WAS EXPLANTED. THE IOL WAS REPLACED WITH ANOTHER ZMA IOL. A VITRECTOMY WAS NOT REQUIRED DURING THE PROCEDURE. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    368973 TECNIS MULTIFOCAL IOLS MFK ABBOTT MEDICAL OPTICS ZMA00

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention