BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF IQ TORIC

    MDR report key: 2297821 · Received October 7, 2011

    Report

    Report Number
    1119421-2011-01226
    Event Type
    Injury
    Date Received
    October 7, 2011
    Date of Event
    January 1, 2011
    Report Date
    September 9, 2011
    Manufacturer
    ALCON RESEARCH, LTD. / HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. NO ROOT CAUSE COULD BE IDENTIFIED BY THE INVESTIGATION. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ADDITIONAL INFORMATION WAS REQUESTED ON 09/09/2011, 09/12/2011 AND 09/23/2011 BY FAX, PHONE AND MAIL. ADDITIONAL INFORMATION WAS RECEIVED BY PHONE ON 09/23/2011 AND 10/05/2011. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED AN UNEXPECTED OUTCOME FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. ADDITIONAL INFORMATION WAS RECEIVED FROM THE SURGEON, WHO REPORTED THE PATIENT'S "BAG" WAS LARGE AND THE IOL SHIFTED IN THE BAG OVER THE FIRST FEW DAYS AFTER SURGERY. SHE STATED THE "IOL" LOOKS ROTATED SLIGHTLY NASALLY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF IQ TORIC INTRAOCULAR LENS HQL ALCON RESEARCH, LTD. / HUNTINGTON SN6AT7 12021546

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Other