BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS ACRYLIC

    MDR report key: 1011888 · Received March 11, 2008

    Report

    Report Number
    2648035-2008-00006
    Event Type
    Injury
    Date Received
    March 11, 2008
    Date of Event
    February 25, 2008
    Report Date
    February 19, 2008
    Manufacturer
    ADVANCED MEDICAL OPTICS
    Product Code
    HQL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL OF THE EXPLANTED LENS CONFIRMED THE IOL MEASURED 25.5 DIOPTERS AND NOT 14.5 DIOPTERS AS LABELED. PROD HISTORY RECORDS INDICATE THE PROD MET RELEASE CRITERIA. THERE HAVE BEEN NO OTHER COMPLAINTS REC'D FOR THIS BATCH RECORD. A SECOND UNUSED LENS FROM THE SAME BATCH RECORD WAS MEASURED FOR DIOPTER AND WAS CORRECT AS LABELED, 14.5 DIOPTERS. THE ROOT CAUSE OF THIS EVENT WAS NOT DETERMINED AND OUR INVESTIGATION IS ONGOING.

    Description of Event or Problem · 1

    THE LENS WAS REMOVED AND REPLACED DUE TO AN UNEXPECTED POST OPERATIVE VISUAL ACUITY. THE PHYSICIAN REPLACED THE LENS WITH ANOTHER OF THE SAME DIOPTER. PT'S CURRENT VISUAL ACUITY IS UNK.

    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