BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF IQ TORIC

    MDR report key: 1852404 · Received September 28, 2010

    Report

    Report Number
    1119421-2010-01067
    Event Type
    Injury
    Date Received
    September 28, 2010
    Date of Event
    January 1, 2010
    Report Date
    August 11, 2010
    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
    WI, 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 INFORMATION WAS REQUESTED ON 09/27/2010 AND 09/28/2010 BY PHONE, FAX AND MAIL. A COMPLETED QUESTIONNAIRE HAS NOT BEEN REC'D. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED, A PT WITH BILATERAL INTRAOCULAR LENSES (IOLS) EXPLANTED DUE TO REFRACTIVE SURPRISES. BOTH LENSES WERE EXCHANGED FOR THE SAME MODEL LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS REPORT IS FOR THE FELLOW EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF IQ TORIC INTRAOCULAR LENS HQL ALCON RESEARCH, LTD / HUNTINGTON SN6AT4 10970596

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention