BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF TORIC

    MDR report key: 923343 · Received October 4, 2007

    Report

    Report Number
    1119421-2007-00396
    Event Type
    Other
    Date Received
    October 4, 2007
    Date of Event
    January 1, 2007
    Report Date
    September 4, 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
    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. ADDITIONAL INFORMATION WAS REQUESTED 09/07/2007, 09/10/2007 AND 09/20/2007 BY FAX, MAIL AND PHONE. ADDITIONAL INFORMATION WAS RECEIVED ON 09/04/2007, 09/05/2007, 09/10/2007 AND 09/21/2007 BY PHONE. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RETURNED.

    Description of Event or Problem · 1

    A CONSUMER REPORTS SEEING GLARE AND STARBURSTS FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. ADDITIONAL INFORMATION, INCLUDING PATIENT STATUS, HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF TORIC INTRAOCULAR LENS HQL ALCON LABORATORIES, INC./HUNTINGTON SN60T5 152447

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Other