BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF IQ TORIC

    MDR report key: 1514595 · Received October 16, 2009

    Report

    Report Number
    1119421-2009-00978
    Event Type
    Other
    Date Received
    October 16, 2009
    Date of Event
    June 1, 2009
    Report Date
    September 16, 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; 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 09/21/2009, 09/24/2009, AND 09/29/2009 BY PHONE, FAX, AND MAIL. A COMPLETED QUESTIONNAIRE WAS RECEIVED ON 10/15/2009. (B) (4). (B) (4). (B) (4).

    Description of Event or Problem · 1

    A SURGEON REPORTED TWO PATIENTS WITH AN UNEXPECTED POSTOPERATIVE REFRACTION FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. THERE ARE THREE MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS REPORT IS FOR THE FIRST OF TWO PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF IQ TORIC INTRAOCULAR LENS MJP ALCON RESEARCH, LTD. / HUNTINGTON SN6AT3 10903258

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other VISCOELASTIC