BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS 1-PIECE

    MDR report key: 2923410 · Received January 22, 2013

    Report

    Report Number
    2648035-2013-00025
    Event Type
    Injury
    Date Received
    January 22, 2013
    Date of Event
    December 17, 2012
    Report Date
    January 10, 2013
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). USED FOR EXPLANT OF INTRAOCULAR LENS. ALL PERTINENT INFORMATION AVAILABLE TO THE MANUFACTURER HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4): THE INTRAOCULAR LENS DIOPTER WAS CHANGED FROM 20.0 D TO 19.0 D.ALL PERTINENT INFORMATION AVAILABLE TO THE MANUFACTURER HAS BEEN SUBMITTED. (B)(4): PLACEHOLDER.

    Description of Event or Problem · 1

    WE RECEIVED A REPORT CONCERNING A PATIENT WHO HAD AN INTRAOCULAR LENS (IOL) EXPLANTED AFTER EXPERIENCING CHROMATIC ABERRATION. THE LENS WAS DISCARDED AND WILL NOT BE RETURNED FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30810 TECNIS 1-PIECE MONOFOCAL IOLS HQL ABBOTT MEDICAL OPTICS ZCB00

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention