BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF IQ TORIC

    MDR report key: 2230589 · Received August 12, 2011

    Report

    Report Number
    1119421-2011-00994
    Event Type
    Injury
    Date Received
    August 12, 2011
    Date of Event
    July 13, 2011
    Report Date
    July 15, 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
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVALUATION: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. THE PRODUCT HISTORY RECORDS COULD NOT BE REVIEWED BECAUSE THE REPORTING FACILITY DID NOT PROVIDE A LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MANUFACTURING DOCUMENTATION. ROOT CAUSE: THE ROOT CAUSE CANNOT BE DETERMINED. NOT ENOUGH INFORMATION WAS PROVIDED FROM THE ACCOUNT TO PROPERLY COMPLETE AN 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. ADDITIONAL INFORMATION WAS REQUESTED ON 07/15/2011, 07/18/2011 AND 08/05/2011 BY PHONE, FAX, AND MAIL. ADDITIONAL INFORMATION WAS RECEIVED ON 08/05/2011 BY PHONE. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED A PATIENT WITH A REFRACTIVE SURPRISE FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. THE SURGEON STATED THAT LENS DID NOT CORRECT ALL THE ASTIGMATISM AS EXPECTED. IN A FOLLOW-UP, THE TECHNICIAN REPORTED THAT THE EVENT HAS RESOLVED AND EACH TIME THE PATIENT HAS COME IN, HIS VISION GETS BETTER. HE ALSO REPORTED THAT NO SURGICAL INTERVENTION WAS REQUIRED. ADDITIONAL HAS BEE REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF IQ TORIC INTRAOCULAR LENS HQL ALCON RESEARCH, LTD. / HUNTINGTON SN6AT8 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other