BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF IQ TORIC

    MDR report key: 2231168 · Received August 26, 2011

    Report

    Report Number
    1119421-2011-01062
    Event Type
    Injury
    Date Received
    August 26, 2011
    Date of Event
    January 1, 2011
    Report Date
    July 29, 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
    TX, 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. NO FURTHER ACTION IS WARRANTED AT THIS TIME. 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 07/29/2011, 08/10/2011 AND 08/01/2011 BY FAX, PHONE AND MAIL. A COMPLETED QUESTIONNAIRE HAS NOT BE RECEIVED. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED A PT EXPERIENCING BLURRED VISION AND "VISION IS NOT AS GOOD" FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. HE NOTED THE LENS WAS IMPLANTED BY ANOTHER SURGEON IN 2009 AND THE PT CAME TO HIM FOR A SECOND OPINION. HE REPORTED UPON EXAMINING THE PT HE NOTED THE LENS WAS OFF AXIS RESULTING IN AN UNEXPECTED OUTCOME AND ASTIGMATISM. HE NOTED THE OPERATIVE REPORT STATED THAT THE LENS WAS "CENTERED NICELY" AND MADE NO MENTION OF THE LENS BEING OFF AXIS. HE STATED AT THIS TIME HE COULD NOT PROVIDE ANY ADDITIONAL INFORMATION. IN FOLLOW-UP, THE INITIAL SURGEON STATED HE WAS UNABLE TO PROVIDE ANY INFORMATION REGARDING THE PT WITHOUT PT IDENTIFIERS. 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 10940129

    Patients

    Seq Age Sex Outcome Treatment
    1 Other