BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF IQ TORIC

    MDR report key: 2230547 · Received August 12, 2011

    Report

    Report Number
    1119421-2011-00988
    Event Type
    Injury
    Date Received
    August 12, 2011
    Date of Event
    July 1, 2011
    Report Date
    July 14, 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
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVAL: THE PROD HAS NOT BEEN RECEIVED FOR EVAL. PROD HISTORY RECORDS WERE REVIEWED AND ALL DOCUMENTS INDICATE THE PROD MET RELEASE CRITERIA. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ADD'L INFO WAS REQUESTED 07/14/2011, 07/18/2011 AND 08/01/2011 BY FAX, PHONE AND MAIL. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED. (B)(4).

    Description of Event or Problem · 1

    A NURSE REPORTED FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY, A CENTRAL INFERIOR DEFECT WAS NOTED IN THE LENS. SHE STATED THE DEFECT WAS AFFECTING THE PT'S VISION AND LENS WAS EXPLANTED AND REPLACED WITH ANOTHER IOL. 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 10974370

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention