BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS

    MDR report key: 2023894 · Received March 18, 2011

    Report

    Report Number
    2648035-2011-00042
    Event Type
    Injury
    Date Received
    March 18, 2011
    Date of Event
    February 18, 2011
    Report Date
    February 18, 2011
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    PMA / PMN Number
    P99080/S06
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE LENS WAS RECEIVED AND INSPECTED UNDER ILLUMINATED 10X MAGNIFICATION. ONE DISTORTED HAPTIC AND A BENT OPTIC WERE OBSERVED. DAMAGE TO THE LENS OCCURRED WHEN LOADING INTO THE INSERTION SYSTEM AND IS NOT RELATED TO THE MANUFACTURING PROCESS. ALL AVAILABLE INFORMATION IS PROVIDED IN THIS REPORT.

    Description of Event or Problem · 1

    A NURSE REPORTED THE INTRAOCULAR LENS WAS LOADED INCORRECTLY INTO THE INSERTION SYSTEM AND WOULD NOT ADVANCE COMPLETELY INTO THE PATIENT'S EYE. THE INCISION WAS ENLARGED AND ANOTHER LENS IMPLANTED WITHOUT INJURY OR FURTHER COMPLICATIONS. THE CASE WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TECNIS MONOFOCAL LENS HQL ABBOTT MEDICAL OPTICS ZA9003

    Patients

    Seq Age Sex Outcome Treatment
    1 Other