BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF IQ TORIC

    MDR report key: 1625230 · Received March 5, 2010

    Report

    Report Number
    1119421-2010-00229
    Event Type
    Injury
    Date Received
    March 5, 2010
    Date of Event
    January 1, 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; 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. ADD'L INFO WAS REQUESTED ON 02/08/2010, 02/09/2010, 02/23/2010, 02/25/2010, 02/26/2010, AND 03/30/2010 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 THAT THE FOLLOWING INTRAOCULAR LENS (IOL) EXCHANGE SURGERY, HE CONTINUES TO EXPERIENCE UNCORRECTED ASTIGMATISM. MEDICAL RECORDS WERE REQUESTED AND RECEIVED. ACCORDING TO THE MEDICAL RECORDS, THE INTRAOCULAR PRESSURES (IOP) BEGAN TO STEADILY RISE FOLLOWING THE IOL EXCHANGE PROCEDURE DESPITE TREATMENT WITH MEDICATIONS. THE LAST RECORDED IOPS WERE IN THE 25-30 MMHG RANGE. ADD'L INFO HAS BEEN REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS REPORT IS FOR THE REPLACEMENT IOL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF IQ TORIC INTRAOCULAR LENS HQL ALCON RESEARCH, LTD. / HUNTINGTON SN6AT5 10913073

    Patients

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