BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF IQ TORIC

    MDR report key: 1579915 · Received January 13, 2010

    Report

    Report Number
    1119421-2010-00010
    Event Type
    Other
    Date Received
    January 13, 2010
    Date of Event
    January 1, 2009
    Report Date
    December 14, 2009
    Manufacturer
    ALCON RESEARCH, LTD. / HUNTINGTON
    Product Code
    MJP
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR ANALYSIS; DEVICE REMAINS IMPLANTED. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ADD'L INFO WAS REQUESTED ON 12/21/2009 AND 01/05/2010 BY FAX, MAIL AND PHONE. MEDICAL RECORDS WERE RECEIVED. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED. (B) (4). (B) (4). (B) (4).

    Description of Event or Problem · 1

    A SURGEON REPORTS HAVING A PT WITH A REFRACTIVE SURPRISE FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. POSTOPERATIVELY, THE PT WAS TREATED FOR DRY EYES AND TRACE POSTERIOR CAPSULAR OPACIFICATION WAS OBSERVED. ADD'L INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF IQ TORIC INTRAOCULAR LENS MJP ALCON RESEARCH, LTD. / HUNTINGTON SN6AT3 10952784

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other