BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF TORIC

    MDR report key: 1290888 · Received December 10, 2008

    Report

    Report Number
    1119421-2008-00998
    Event Type
    Other
    Date Received
    December 10, 2008
    Date of Event
    November 7, 2008
    Report Date
    November 10, 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
    AZ, 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 11/12/2008, 11/13/2008, 11/18/2008, AND 11/25/2008 BY PHONE, FAX, AND MAIL; AND RECEIVED ON 11/26/2008.

    Description of Event or Problem · 1

    A CONSUMER REPORTED EXPERIENCING BLURRY VISION APPROX THREE WEEKS FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. IN A FOLLOW-UP, THE SURGEON REPORTED THAT, ONE MONTH POSTOPERATIVELY, THE IOL IS POSITIONED CORRECTLY AND CLEAR; AND THAT THE PT'S VISION WITH CORRECTION IS 20/20.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF TORIC INTRAOCULAR LENS MJP ALCON RESEARCH, LTD./HUNTINGTON SN60T3 10834576

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other