BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF TORIC

    MDR report key: 1061289 · Received June 13, 2008

    Report

    Report Number
    1119421-2008-00442
    Event Type
    Injury
    Date Received
    June 13, 2008
    Date of Event
    January 1, 2008
    Report Date
    May 15, 2008
    Manufacturer
    ALCON RESEARCH, LTD./HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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. ADDITIONAL INFO WAS REQUESTED 06/06/2008 BY MAIL AND FAX. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED. TO FDA ON: 06/13/2008.

    Description of Event or Problem · 1

    A REGISTERED NURSE REPORTED THAT A TEAR WAS NOTED IN AN INTRAOCULAR LENS (IOL) ONCE IT WAS IMPLANTED. THE LENS WAS REMOVED DURING THE SAME PROCEDURE THROUGH AN ENLARGED INCISION. 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 SN60T4 954701

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention