BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACRYSOF TORIC

    MDR report key: 1203278 · Received October 17, 2008

    Report

    Report Number
    1119421-2008-00821
    Event Type
    Malfunction
    Date Received
    October 17, 2008
    Date of Event
    January 1, 2008
    Report Date
    September 17, 2008
    Manufacturer
    ALCON RESEARCH LTD/HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATES THE PRODUCT MET RELEASE CRITERIA. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ADDITIONAL INFO WAS REQUESTED ON 09/18/2008 AND 10/09/2008 BY MAIL. A COMPLETED QUESTIONAIRE HAS NOT BEEN RECEIVED.

    Description of Event or Problem · 1

    A USER FACILITY REPORTS A SCRATCH MARK ON AN INTRAOCULAR LENS (IOL). PT IMPACT REMAINS UNK. ADDITIONAL INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF TORIC INTRAOCULAR LENS HQL ALCON RESEARCH LTD/HUNTINGTON SN60T5 10810766

    Patients

    Seq Age Sex Outcome Treatment
    1 NA