BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALCON LABORATORIES

    MDR report key: 1050126 · Received May 22, 2008

    Report

    Report Number
    MW5007003
    Event Type
    Malfunction
    Date Received
    May 22, 2008
    Date of Event
    May 7, 2008
    Report Date
    May 15, 2008
    Manufacturer
    ALCON LABORATORIES, INC.
    Product Code
    MFK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING IMPLANTATION OF INTRA-OCULAR LENS, MD LOOKING UNDER MICROSCOPE AND NOTED A 'LINE' ACROSS THE CENTER OF THE LENS. LENS SAFELY REMOVED. PACKAGE CONTAINED ACRYSOF RESTOR APODIZED DIFFRACTIVE OPTIC, SOFT ACRYLIC SINGLE-PIECE STERILE PCL, 13.0MM LENGTH, 6.0MM BICONVEX OPTIC, PLANAR HAPTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALCON LABORATORIES ACRYSOF RESTOR APODIZED DIFFRACTIVE IOL MFK ALCON LABORATORIES, INC. SN60D3

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR