BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF TORIC

    MDR report key: 1321337 · Received February 18, 2009

    Report

    Report Number
    1119421-2009-00114
    Event Type
    Other
    Date Received
    February 18, 2009
    Date of Event
    December 30, 2008
    Report Date
    January 9, 2009
    Manufacturer
    ALCON RESEARCH, LTD./HUNTINGTON
    Product Code
    MJP
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR ANALYSIS; 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 INFORMATION WAS REQUESTED ON 01/20/2009, 01/21/2009, AND 02/05/2009 BY PHONE, FAX, AND MAIL. A COMPLETED QUESTIONNAIRE WAS RECEIVED ON 01/30/2009.

    Description of Event or Problem · 1

    A SURGEON REPORTED A PATIENT EXPERIENCING AN UNEXPECTED POSTOPERATIVE REFRACTION FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. THE SURGEON IS PLANNING TO ROTATE THE IOL. IN THE OPINION OF THE SURGEON, THE DEVICE DID NOT CAUSE/CONTRIBUTE TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF TORIC INTRAOCULAR LENS MJP ALCON RESEARCH, LTD./HUNTINGTON SN60T4 10817639

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Other VISCOELASTIC| VIGAMOX