BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF IQ TORIC

    MDR report key: 2484625 · Received March 7, 2012

    Report

    Report Number
    1119421-2012-00297
    Event Type
    Injury
    Date Received
    March 7, 2012
    Date of Event
    January 1, 2012
    Report Date
    February 6, 2012
    Manufacturer
    ALCON RESEARCH, LTD. / HUNTINGTON
    Product Code
    HQL
    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

    EVAL SUMMARY: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. THE ROOT CAUSE COULD NOT BE IDENTIFIED BY THE INVESTIGATION. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ADDITIONAL INFO WAS REQUESTED ON 02/08/2012 AND 02/16/2012 BY PHONE, FAX, AND MAIL. ADDITIONAL INFO WAS RECEIVED BY PHONE ON 02/16/2012 AND 02/24/2012. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED A PT WITH AN UNEXPECTED OUTCOME FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. THE SURGEON STATED HE IS "UNCERTAIN AS TO THE FULL EXPLANTATION OF THE SIGNIFICANT OVERCORRECTION OF CYLINDER". IN A F/U, THE SURGICAL COORDINATOR REPORTED THE LENS WAS REPOSITIONED AND THERE WAS IMPROVEMENT IN THE PT'S VISION AFTER ROTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF IQ TORIC INTRAOCULAR LENS HQL ALCON RESEARCH, LTD. / HUNTINGTON SN6AT9 12084738

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention