BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF IQ TORIC

    MDR report key: 1760549 · Received July 15, 2010

    Report

    Report Number
    1119421-2010-00811
    Event Type
    Injury
    Date Received
    July 15, 2010
    Date of Event
    January 1, 2010
    Report Date
    June 15, 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
    TX, US
    Reporter Occupation
    OTHER

    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 6/16/10, 7/2/10 AND 7/6/10 BY PHONE, FAX, AND MAIL. ADD'L INFO WAS RECEIVED 6/16/10 AND 7/6/10 BY PHONE. A COMPLETED QUESTIONAIRE HAS NOT BEEN RECEIVED. (B)(4).

    Description of Event or Problem · 1

    ADVERSE EVENT(S): "UNEXPECTED POSTOPERATIVE REFRACTION" (POSTOPERATIVE REFRACTION, UNEXPECTED). PRODUCT PROBLEM(S): "NONE REPORTED" (NO INFO [IOL (INTRAOCULAR LENS) IMPLANT]). A SURGEON REPORTED THAT HIS COLLEAGUE HAD A PT WITH AN UNEXPECTED POSTOPERATIVE REFRACTION FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. THE LENS WAS EXCHANGED AND THE PT IS REPORTED TO BE DOING VERY WELL. IN A F/U, THE IMPLANTING SURGEON STATED SHE DOES NOT BLAME THE LENS FOR THE EVENT; THIS IS THE FIRST LENS OF THIS TYPE SHE HAS IMPLANTED. ADD'L INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF IQ TORIC INTRAOCULAR LENS HQL ALCON RESEARCH, LTD./HUNTINGTON SN6AT5 10982093

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention