BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF IQ TORIC

    MDR report key: 2180911 · Received July 22, 2011

    Report

    Report Number
    1119421-2011-00903
    Event Type
    Injury
    Date Received
    July 22, 2011
    Date of Event
    June 1, 2011
    Report Date
    June 23, 2011
    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
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVAL: RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. NO MALFUNCTION CAN BE DETERMINED AT THIS TIME. ROOT CAUSE: ROOT CAUSE HAS NOT BEEN IDENTIFIED. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ADD'L INFO WAS REQUESTED ON 6/24/2011, 6/27/2011, AND 7/8/2011 BY PHONE, FAX, AND MAIL. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED. (B)(4).

    Description of Event or Problem · 1

    A SURGICAL TECH REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS EXCHANGED DUE TO A SCRATCH IN THE CTR OF THE LENS. THE PT WAS HAVING TO LOOK AROUND THE SCRATCH TO SEE WELL. THE IOL WAS REPLACED WITH THE SAME MODEL AND DIOPTER LENS. ADD'L INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF IQ TORIC INTRAOCULAR LENS HQL ALCON RESEARCH, LTD/HUNTINGTON SN6AT4 12001172

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention