BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF TORIC

    MDR report key: 1211541 · Received October 3, 2008

    Report

    Report Number
    1119421-2008-00781
    Event Type
    Other
    Date Received
    October 3, 2008
    Date of Event
    June 1, 2008
    Report Date
    September 5, 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 09/12/2008 AND 09/24/2008 BY PHONE, FAX, AND MAIL. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED. THIS REPORT WAS MAILED TO FDA ON: 10/03/2008.

    Description of Event or Problem · 1

    A SURGEON REPORTS FIVE PATIENTS WITH UNEXPECTED POSTOPERATIVE REFRACTIONS FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. THIS REPORT IS FOR THE SECOND OF THE FIVE PATIENTS. THIS PATIENT WAS IMPLANTED BILATERALLY. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS REPORT IS FOR THE RIGHT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF TORIC INTRAOCULAR LENS MJP ALCON RESEARCH LTD, /HUNTINGTON SN60T3 123851

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Other