BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACRYSOF

    MDR report key: 1033727 · Received April 11, 2008

    Report

    Report Number
    1033727
    Event Type
    Malfunction
    Date Received
    April 11, 2008
    Date of Event
    April 1, 2008
    Report Date
    April 11, 2008
    Manufacturer
    ALCON LABORATORIES, INC.
    Product Code
    HQL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    INSERTION OF INTRAOCULAR LENS, LOWER HAPTIC WAS NOT THERE. DOCTOR REMOVED LENS AND REINSERTED NEW LENS. THE DOCTOR STATES, NO HAPTIC FOUND IN PATIENT UNDER EXAMINATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF LENS, INTRAOCULAR HQL ALCON LABORATORIES, INC. SN60WF *

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR