BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF IQ TORIC

    MDR report key: 2230662 · Received August 12, 2011

    Report

    Report Number
    1119421-2011-00986
    Event Type
    Injury
    Date Received
    August 12, 2011
    Date of Event
    July 13, 2011
    Report Date
    July 14, 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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: PRODUCT EVALUATION: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. ROOT CAUSE: THE ROOT CAUSE COULD NOT 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 07/14/2011, 07/18/2011, 08/01/2011 AND 08/08/2011 BY FAX, PHONE AND MAIL. A COMPLETED QUESTIONNAIRE WAS RECEIVED ON 07/19/2011. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY, THE LENS SHIFTED POSITION. HE STATED THE PATIENT HAD LIMBAL RELAXING INCISION (LRI) SURGERY WHICH OVERCORRECTED THE ASTIGMATISM. THE SURGEON REPORTED DUE TO THE OVERCORRECTION THE LENS WAS EXCHANGED FOR A MONOFOCAL LENS AND THE PATIENT'S SYMPTOMS HAVE RESOLVED. HE NOTED THE IOL DID NOT CAUSE OR CONTRIBUTE TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF IQ TORIC INTRAOCULAR LENS HQL ALCON RESEARCH, LTD. / HUNTINGTON SN6AT9 12058222

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention DUOVISC