BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF IQ TORIC

    MDR report key: 2113781 · Received June 2, 2011

    Report

    Report Number
    1119421-2011-00676
    Event Type
    Injury
    Date Received
    June 2, 2011
    Date of Event
    January 1, 2011
    Report Date
    May 3, 2011
    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
    MO, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVALUATION: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. ROOT CAUSE: NO ROOT CAUSE COULD BE IDENTIFIED BY THE INVESTIGATION. ACTION TAKEN: INVESTIGATION HAS BEEN COMPLETED BASED ON CURRENT INFORMATION. CONCLUSION: BASED ON OUR CURRENT TRACKING, THERE ARE NO ADVERSE TRENDS FOR THIS REPORTED COMPLAINT AND BASED ON THESE FINDINGS THE RESIDUAL RISK REMAINS UNCHANGED AND AT AN ACCEPTABLE LEVEL. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ADDITIONAL INFORMATION WAS REQUESTED ON 05/12/2011 AND 05/26/2011 BY PHONE, FAX, AND MAIL. MEDICAL RECORDS WERE RECEIVED ON 05/03/2011. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED. (B)(4).

    Description of Event or Problem · 1

    A NURSE REPORTED A PATIENT WITH AN UNEXPECTED POSTOPERATIVE REFRACTION FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. MEDICAL RECORDS WERE ALSO RECEIVED AND INDICATED THAT, FIVE WEEKS POSTOPERATIVELY, THE PATIENT REPORTED EYE PAIN, LIGHT SENSITIVITY, SEES "A FILM OVER THE EYE", EYE IS WATERY AND FEELS TIRED, HEAVY AND DRY. THE PATIENT WAS GIVEN ARTIFICIAL TEARS AND A PRESCRIPTION FOR GLASSES TO USE AS NEEDED; AND THE SURGEON'S OVERALL IMPRESSION IS THAT THE PATIENT IS "DOING WELL." 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 SN6AT3 11029867

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention DEXILANT| LABETALOL| TUMS| SIMVASTATIN