BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF TORIC

    MDR report key: 1217071 · Received October 31, 2008

    Report

    Report Number
    1644019-2008-00031
    Event Type
    Injury
    Date Received
    October 31, 2008
    Date of Event
    January 1, 2008
    Report Date
    October 1, 2008
    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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR ANALYSIS; THE DEVICE REMAINS IMPLANTED. RESULTS FROM THE PRODUCT HISTORY RECORDS REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ADDITIONAL INFO WAS REQUESTED BY FAX AND MAIL ON 10/06/2008 AND BY PHONE ON 10/02/2008 AND 10/15/2008. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED. THIS REPORT WAS MAILED TO FDA ON: 10/31/2008.

    Description of Event or Problem · 1

    A SURGICAL TECHNICIAN REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANT SURGERY, THE CAPSULAR BAG TORE. 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 SN60T5 10810740

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Other