BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF IQ TORIC

    MDR report key: 2932231 · Received January 25, 2013

    Report

    Report Number
    1119421-2013-00065
    Event Type
    Injury
    Date Received
    January 25, 2013
    Date of Event
    January 1, 2012
    Report Date
    December 26, 2012
    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
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    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. THE PRODUCT INVESTIGATION COULD NOT IDENTIFY A ROOT CAUSE. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION. A COMPLETED QUESTIONAIRE HAS NOT BEEN RECEIVED. (B)(4).

    Description of Event or Problem · 1

    A PURCHASING EMPLOYEE REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS EXCHANGED DUE TO THE PT EXPERIENCING GLARE, HALOS AND HIGH ASTIGMATISM. THE LENS WAS EXCHANGED FOR A MONOFOCAL LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    35904 ACRYSOF IQ TORIC INTRAOCULAR LENS HQL ALCON RESEARCH, LTD / HUNTINGTON SN6AT7 12082725

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention