BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACRYSOF IQ IOL 29.5 D

    MDR report key: 1982011 · Received January 26, 2011

    Report

    Report Number
    1982011
    Event Type
    Malfunction
    Date Received
    January 26, 2011
    Date of Event
    November 18, 2010
    Report Date
    January 25, 2011
    Manufacturer
    ALCON LABORATORIES, INC.
    Product Code
    HQL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IN, US

    Narratives

    Description of Event or Problem · 1

    AFTER SURGEON INJECTED NEWLY IMPLANTED LENS, IT WAS NOTICED ONE OF THE HAPTICS WAS BROKEN OFF THE LENS. LENS EXPLANTED AND NEW LENS IMPLANTED WITHOUT INCIDENT. COMPLAINT QUESTIONNAIRE COMPLETED AND GIVEN TO SALES REPRESENTATIVE.====================== HEALTH PROFESSIONAL'S IMPRESSION======================LENS "TOO" WARM AND SOFT WITH INSERTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF IQ IOL 29.5 D INTRA OCULAR IMPLANT HQL ALCON LABORATORIES, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR NO OTHER THERAPIES