BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF

    MDR report key: 727974 · Received June 16, 2006

    Report

    Report Number
    1119421-2006-00191
    Event Type
    Injury
    Date Received
    June 16, 2006
    Report Date
    May 17, 2006
    Manufacturer
    ALCON LABORATORIES, INC./HUNTINGTON
    Product Code
    HQL
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    H.3.,6: THE COMPLAINT DEVICE ASSOCIATED WITH THIS REPORT HAS NOT BEEN RECEIVED FOR EVALUATION. THE DEVICE REMAINS IMPLANTED. PRODUCT HISTORY RECORDS COULD NOT BE REVIEWED BECAUSE THE REPORTED DID NOT PROVIDE A LENS SERIAL NUMBER, LOT NUMBER, OR ANY IDENTIFICATION TRACEABLE TO THE MANUFACTURING DOCUMENTATION.

    Description of Event or Problem · 1

    THE FOLLOWING CASE REPORT WAS RECENTLY PUBLISHED IN A JOURNAL (ARTICLE ATTACHED. A MAN WHO HAD UNEVENTFUL BILATERAL CATARACT SURGERY WITH VISUAL ACUITY OF 20/15 WITHOUT CORRECTION PRESENTED WITH SEVERE POSITIVE DYSPHOTOPSIA. TREATMENT WITH BRIMONIDINE OR PILOCARPINE DID NOT RESOLVE THE SYMPTOMS. A MULTIPLE SILICONE INTRAOCULAR LENS WAS PIGGYBACKED INTO THE SULCUS FOR EACH EYE AND THE PT NO LONGER REPORTED DYSPHOTOPSIA. INITIAL IMPLANT SURGERY OD 2003; 24/2003. OS--PIGGYBACK LENS PLACED IN SULCUS 2005. OD-- PIGGYBACK LENS PLACED IN SULCUS ONE WEEK AFTER OS. SYMPTOMS REAPPEARED FOR LEFT EYE IN JULY 2005. PIGGYBACK LENS IN LEFT EYE HAD DECENTERED TEMPORALLY AND WAS REPOSITIONED IN 2005. SYMPTOMS VANISHED. NOTE: THE USE OF TWO LENSES IN ONE EYE IS NOT INCLUDED IN THE LABELING FOR THIS LENS. MFR REPORT # 1119421-2006-00191-- OD (RIGHT EYE). MFR REPORT # 1119421-2006-00192--OS (LEFT EYE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRAOCULAR LENS HQL ALCON LABORATORIES, INC./HUNTINGTON SN60AT 782090

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention