BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF IQ TORIC

    MDR report key: 1625227 · Received March 5, 2010

    Report

    Report Number
    1119421-2010-00228
    Event Type
    Injury
    Date Received
    March 5, 2010
    Date of Event
    January 12, 2010
    Report Date
    February 5, 2010
    Manufacturer
    ALCON RESEARCH, LTD. / HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ADD'L INFO WAS REQUESTED ON 02/08/2010, 02/09/2010, 02/23/2010, 02/25/2010, 02/26/2010, AND 03/03/2010 BY PHONE, FAX, AND MAIL. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED. MEDICAL RECORDS WERE RECEIVED ON 03/03/2010. (B) (4). (B) (4).

    Description of Event or Problem · 1

    A CONSUMER REPORTED AN INTRAOCULAR LENS (IOL) WAS EXCHANGED DUE TO UNCORRECTED ASTIGMATISM. THE IOL WAS REPLACED WITH THE SAME MODEL, DIFFERENT POWER IOL. THE CONSUMER REPORTED HE HAD A RADIAL KERATOTOMY (RK) PERFORMED IN THE PAST AND FELT THE RK PROCEDURE CONTRIBUTED TO INCORRECT CALCULATIONS FOR THE POWER OF THE IOL. FOLLOWING THE INITIAL IOL IMPLANT PROCEDURE, THE CONSUMER REPORTED HE UNDERWENT A TRABECULECTOMY DUE TO INCREASE INTRAOCULAR PRESSURE (IOP). THE CONSUMER IS ALSO BEING TREATED WITH MEDICATIONS FOR HIS ELEVATED IOP. MEDICAL RECORDS WERE REQUESTED AND RECEIVED. ACCORDING TO THE MEDICAL RECORDS, THE PT HAD PREEXISTING GLAUCOMA AND WAS BEING TREATED WITH MEDICATIONS PRIOR TO HIS IOL IMPLANT SURGERY. THE IOPS WERE ELEVATED FOLLOWING THE IOL IMPLANT SURGERY AND A TRABECULECTOMY WAS PERFORMED. THE PT'S MEDICATIONS WERE ADJUSTED FOLLOWING THE TRABECULECTOMY. ADD'L INFO HAS BEEN REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS REPORT IS FOR THE INITIAL IOL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF IQ TORIC INTRAOCULAR LENS HQL ALCON RESEARCH, LTD. / HUNTINGTON SN6AT5 10903356

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention TRAVATAN| INSULIN| LOTEMAX| METFORMIN| OMEGA 3