BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF IQ TORIC

    MDR report key: 1772217 · Received July 22, 2010

    Report

    Report Number
    1119421-2010-00843
    Event Type
    Injury
    Date Received
    July 22, 2010
    Date of Event
    May 10, 2010
    Report Date
    June 22, 2010
    Manufacturer
    ALCON RESEARCH, LTD./HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR ANALYSIS; THE DEVICE REMAINS IMPLANTED. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ADDITIONAL INFORMATION WAS REQUESTED ON 06/24/2010, 06/28/2010, AND 07/02/2010 BY PHONE, FAX, AND MAIL. A COMPLETED QUESTIONNAIRE WAS RECEIVED ON 07/02/2010. MEDICAL RECORDS WERE RECEIVED ON 06/24/2010. (B)(4).

    Description of Event or Problem · 1

    ADVERSE EVENT(S): "WET AGE RELATED MACULAR DEGENERATION" (NO CODE AVAILABLE); "VISION DARK" (VISION, IMPAIRED). PRODUCT PROBLEM(S): "DEPOSITS NOTED IN IOL" (DEFECTIVE ITEM [IOL (INTRAOCULAR LENS) IMPLANT]). A SURGEON REPORTED A BUBBLE OR DEFECT WAS NOTED IN AN INTRAOCULAR LENS (IOL) FOLLOWING IOL IMPLANT SURGERY. MEDICAL RECORDS WERE REQUESTED AND RECEIVED. ACCORDING TO THE MEDICAL RECORDS, THE PATIENT HAD A HISTORY OF HYPERTENSION, HYPERCHOLESTEROLEMIA, STATUS POST SEVERE HEAD INJURY, AGE RELATED MACULAR DEGENERATION, EPIRETINAL MEMBRANE, DRUSEN WITH RETINAL PIGMENT EPITHELIUM DETACHMENT, POSTERIOR VITREAL DETACHMENT AND WAS SUSPECTED OF HAVING GLAUCOMA (PRE-EXISTING).THE PATIENT HAD ALSO REPORTED WAVY VISION AND LIGHT SENSITIVITY PRIOR TO THE IOL IMPLANT PROCEDURE (PRE-EXISTING). A VITRECTOMY AND MEMBRANE PEEL WERE PERFORMED AT THE TIME OF THE IOL IMPLANT SURGERY AS PLANNED PROCEDURES. APPROXIMATELY THREE MONTHS FOLLOWING THE IOL IMPLANT, THE PATIENT REPORTED HIS VISION WAS DARK, ALMOST "BLUE". AT THE TIME OF EXAMINATION, SMALL DEPOSITS WERE NOTED ON THE LENS SURFACE AND A SECONDARY MEMBRANE. THE PATIENT WAS TREATED WITH MEDICATIONS. THE PATIENT RETURNED APPROXIMATELY SIX WEEKS LATER AND WAS STILL REPORTING DARK, DISTORTED VISION. WET AGE RELATED MACULAR DEGENERATION WAS NOTED AND TREATED WITH MEDICATIONS. DEPOSITS WERE STILL NOTED TO BE PRESENT ON THE IOL, BUT WERE NOW OBSERVED WITHIN THE LENS MATERIAL. IN A FOLLOW UP, THE SURGEON REPORTED THE EVENT CONTINUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF IQ TORIC INTRAOCULAR LENS HQL ALCON RESEARCH, LTD./HUNTINGTON SN6AT3 10900565

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention PREVASTATIN, PLAVIX, ASPIRIN, FENOFIBRATE,| LISINOPRIL, EYE VITAMINS, FLAX/OMEGA