BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS

    MDR report key: 1231591 · Received November 14, 2008

    Report

    Report Number
    2648035-2008-00056
    Event Type
    Injury
    Date Received
    November 14, 2008
    Report Date
    December 17, 2008
    Manufacturer
    ADVANCED MEDICAL OPTICS
    Product Code
    HQL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS NOT RECEIVED FOR ANALYSIS. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION FROM THE REPORTER HAVE BEEN UNSUCCESSFUL. PRODUCT MET ALL CRITERIA PRIOR TO RELEASE. THE CAUSE OF THIS INCIDENT IS UNDETERMINABLE.

    Description of Event or Problem · 1

    PHYSICIAN REPORTED THE INTRAOCULAR LENS DISCHARGED TOO QUICKLY FROM THE INSERTION SYSTEM TEARING THE POSTERIOR CAPSULE. THE INCISION WAS ENLARGED AND THE IOL REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TECNIS INTRAOCULAR LENS HQL ADVANCED MEDICAL OPTICS Z9002 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention