BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS ACRYLIC

    MDR report key: 1033297 · Received April 22, 2008

    Report

    Report Number
    2648035-2008-00016
    Event Type
    Injury
    Date Received
    April 22, 2008
    Date of Event
    March 26, 2008
    Report Date
    April 1, 2008
    Manufacturer
    ADVANCED MEDICAL OPTICS
    Product Code
    HQL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED INTRAOCULAR LENS MET MFG SPECIFICATIONS. BOTH HAPTICS WERE INTACT AND UNDAMAGED, OPTIC WAS CLEAR. INCIDENT DOES NOT APPEAR TO BE MFG RELATED. PRODUCT HISTORY RECORDS INDICATE THE PRODUCT MET RELEASE CRITERIA. THE CAUSE OF THE EVENT IS UNDETERMINABLE.

    Description of Event or Problem · 1

    A SURGEON REPORTS AN INTRAOCULAR LENS EXPLANT AND REPLACEMENT AT 6 MOS POST-OPERATIVE DUE TO THE PT'S COMPLAINT OF HALOS. THE RELATIONSHIP BETWEEN THIS EVENT AND THE IOL IS NOT KNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TECNIS ACRYLIC INTRAOCULAR LENS HQL ADVANCED MEDICAL OPTICS ZA9003

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention