BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF TORIC

    MDR report key: 1172758 · Received September 18, 2008

    Report

    Report Number
    1119421-2008-00726
    Event Type
    Other
    Date Received
    September 18, 2008
    Date of Event
    August 1, 2008
    Report Date
    August 19, 2008
    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
    IL, 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 RECORD REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ADDITIONAL INFORMATION WAS REQUESTED ON 08/21/2008, 08/25/2008, AND 09/03/2008 BY PHONE, FAX, AND MAIL. A COMPLETE QUESTIONNAIRE WAS RECEIVED ON 09/10/2008. THIS REPORT WAS MAILED TO FDA ON: 09/18/2008.

    Description of Event or Problem · 1

    AN OFFICE MANGER REPORTS A PATIENT WITH AN UNEXPECTED POSTOPERATIVE REFRACTION FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. IN A FOLLOW-UP, THE SURGEON DID NOT FEEL THE DEVICE CAUSED OR CONTRIBUTED TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF TORIC INTRAOCULAR LENS MJP ALCON RESEARCH, LTD. / HUNTINGTON SN60T5 10826374

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other