BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF TORIC

    MDR report key: 902874 · Received August 24, 2007

    Report

    Report Number
    1119421-2007-00353
    Event Type
    Injury
    Date Received
    August 24, 2007
    Date of Event
    January 1, 2007
    Report Date
    July 26, 2007
    Manufacturer
    ALCON LABORATORIES, INC. / HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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. THIS REPORT WAS MAILED TO THE FDA ON: 08/24/2007. ADD'L INFO WAS REQUESTED 07/30/2007, 08/01/2007 AND 08/02/2007 BY PHONE, MAIL AND FAX. ADD'L INFO WAS RECEIVED 08/01/2007, 08/02/2007 AND 08/07/2007 BY PHONE AND FAX.

    Description of Event or Problem · 1

    A CONSUMER REPORTED THAT FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY, HIS ASTIGMATISM IS NOT IMPROVING. THE SURGEON REPORTS THE PT OUTCOME AS "GOOD".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF TORIC INTRAOCULAR LENS HQL ALCON LABORATORIES, INC. / HUNTINGTON SN60T4 10603631

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention