BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF TORIC

    MDR report key: 1021081 · Received March 27, 2008

    Report

    Report Number
    1119421-2008-00185
    Event Type
    Injury
    Date Received
    March 27, 2008
    Date of Event
    February 1, 2008
    Report Date
    February 26, 2008
    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
    ID, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE ASSOCIATED WAS RETURNED FOR ANALYSIS. BOTH HAPTICS WERE BENT-DISTAL AREA. THE OPTIC WAS SCRATCHED-REJECTABLE. THE COLOR TINT TO THE LENS DID HAVE A SLIGHT YELLOW HUE AND IS ACCEPTABLE PER THE RELEASE CRITERIA. WHILE WE ARE UNABLE TO DETERMINE THE ORIGIN OF THE DAMAGE, OUR OBSERVATION REASONABLY SUGGESTS THAT IT IS NOT MANUFACTURING RELATED. PRODUCT HISTORY RECORDS WERE REVIEWED AND ALL DOCUMENTS INDICATE THE PRODUCT MET RELEASE CRITERIA. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ADD'L INFO WAS REQUESTED 02/28/2008 AND 03/04/2008 BY PHONE, FAX AND MAIL. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RETURNED.

    Description of Event or Problem · 1

    A USER FACILITY REPORTS THAT AN INTRAOCULAR LENS (IOL) WAS EXCHANGED DUE TO ALTERED COLOR PERCEPTION. THE PT IS A PAINTER AND NOTICED A DIFFERENCE IN COLOR DUE TO THE YELLOW COLOR OF THE INITIAL LENS. ADD'L INFO, INCLUDING PT STATUS, HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF TORIC INTRAOCULAR LENS HQL ALCON RESEARCH, LTD./HUNTINGTON SN60T3 10747348

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention