BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS

    MDR report key: 1050315 · Received May 22, 2008

    Report

    Report Number
    2648035-2008-00025
    Event Type
    Injury
    Date Received
    May 22, 2008
    Date of Event
    April 3, 2008
    Report Date
    April 30, 2008
    Manufacturer
    ADVANCED MEDICAL OPTICS
    Product Code
    HQL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LENS WAS RECEIVED CUT IN 2 PIECES ACROSS THE OPTIC MAKING ANALYSIS IMPOSSIBLE. THE LENS WAS REPLACED WITH A HIGHER DIOPTER IOL. A REVIEW OF THE DEVICE HISTORY RECORDS INDICATE, PRODUCT MET ALL CRITERIA PRIOR TO RELEASE. NO ADD'L PRODUCT FROM THE SAME BATCH HAS BEEN REPORTED. THE MANUFACTURER HAS NO REASON TO SUSPECT THE DEVICE WAS THE CAUSE OF THIS INCIDENT.

    Description of Event or Problem · 1

    IT WAS REPORTED, THE PT WAS UNHAPPY WITH HER VISUAL RESULTS. INTRAOCULAR LENS WAS REMOVED AND REPLACED WITH A HIGHER DIOPTER IOL.

    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