BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACRYSOF IQ IOL

    MDR report key: 1481568 · Received September 16, 2009

    Report

    Report Number
    MW5012791
    Event Type
    Malfunction
    Date Received
    September 16, 2009
    Date of Event
    September 15, 2009
    Report Date
    September 16, 2009
    Manufacturer
    ALCON LABORATORIES INC.
    Product Code
    HQL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    IN 2009, A PRE-INSERTION MICROSCOPIC REVIEW OF 24 ACRYSOF IQ IOL IMPLANTS MANUFACTURED BY ALCON LABORATORIES INC. WERE FOUND TO BE DEFECTIVE, I.E. NICKS/DEPRESSIONS NOTED ON SURFACE OF LENS. AN ADDITIONAL 4 LENSES WERE FOUND TO BE DEFECTIVE ON 9/16. WHILE NONE OF THE LENSES WERE IMPLANTED; TWO PLANNED CATARACT EXTRACTIONS AND LENS INSERTIONS WERE CANCELLED AS A RESULT. THE 24 DEFECTIVE LENSES IDENTIFIED THE SAME DAY, WERE GIVEN TO THE COMPANY REPRESENTATIVE WHO FORWARDED TO HOME OFFICE..

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF IQ IOL INTRAOCULAR LENS HQL ALCON LABORATORIES INC.
    10 ACRYSOF IQ IOL INTRAOCULAR LENS HQL ALCON LABORATORIES, INC.
    11 ACRYSOF IQ IOL INTRAOCULAR LENS HQL ALCON LABORATORIES INC.
    12 ACRYSOF IQ IOL INTRAOCULAR LENS HQL ALCON LABORATORIES INC.
    13 ACRYSOF IQ IOL INTRAOCULAR LENS HQL ALCON LABORATORIES INC.
    14 ACRYSOF IQ IOL INTRAOCULAR LENS HQL ALCON LABORATORIES INC.
    15 ACRYSOF IQ IOL INTRAOCULAR LENS HQL ALCON LABORATORIES INC.
    16 ACRYSOF IQ IOL INTRAOCULAR LENS HQL ALCON LABORATORIES INC.
    17 ACRYSOF IQ IOL INTRAOCULAR LENS HQL ALCON LABORATORIES INC.
    18 ACRYSOF IQ IOL INTRAOCULAR LENS HQL ALCON LABORATORIES INC.
    19 ACRYSOF IQ IOL INTRAOCULAR LENS HQL ALCON LABORATORIES INC.
    2 ACRYSOF IQ IOL INTRAOCULAR LENS HQL ALCON LABORATORIES INC.
    20 ACRYSOF IQ IOL INTRAOCULAR LENS HQL ALCON LABORATORIES INC.
    21 ACRYSOF IQ IOL INTRAOCULAR LENS HQL ALCON LABORATORIES INC.
    22 ACRYSOF IQ IOL INTRAOCULAR LENS HQL ALCON LABORATORIES INC.
    23 ACRYSOF IQ IOL INTRAOCULAR LENS HQL ALCON LABORATORIES INC.
    24 ACRYSOF IQ IOL INTRAOCULAR LENS HQL ALCON LABORATORIES INC.
    3 ACRYSOF IQ IOL INTRAOCULAR LENS HQL ALCON LABORATORIES, INC.
    4 ACRYSOF IQ IOL INTRAOCULAR LENS HQL ALCON LABORATORIES INC.
    5 ACRYSOF IQ IOL INTRAOCULAR LENS HQL ALCON LABORATORIES INC.
    6 ACRYSOF IQ IOL INTRAOCULAR LENS HQL ALCON LABORATORIES INC.
    7 ACRYSOF IQ IOL INTRAOCULAR LENS HQL ALCON LABORATORIES INC.
    8 ACRYSOF IQ IOL INTRAOCULAR LENS HQL ALCON LABORATORIES INC.
    9 ACRYSOF IQ IOL INTRAOCULAR LENS HQL ALCON LABORATORIES INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 * 2014| ALCON INTRAOCULAR LENS WITH EXPIRATION DATE OF