BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF IQ TORIC

    MDR report key: 2170075 · Received June 17, 2011

    Report

    Report Number
    1119421-2011-00772
    Event Type
    Other
    Date Received
    June 17, 2011
    Date of Event
    January 1, 2011
    Report Date
    May 19, 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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVAL: 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 INFO. 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 HAS BEEN ONE OTHER SIMILAR COMPLAINT REPORTED IN THE LOT NUMBER. ADDITIONAL INFO WAS REQUESTED ON 05/20/2011 BY FAX AND MAIL. ADDITIONAL INFO WAS RECEIVED ON 05/26/2011 AND 06/08/2011 BY PHONE AND FAX. A COMPLETED QUESTIONNAIRE IS NOT EXPECTED. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED, A PT WITH A REFRACTIVE SURPRISE FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. THE IOL WAS IMPLANTED BY ANOTHER SURGEON. IN A FOLLOW-UP, THE IMPLANTING SURGEON REPORTED THAT THE SURGERY WAS PERFORMED OVER A YEAR AGO AND THAT ACCORDING TO THE PT, THERE IS "NO PROBLEM". IN A FOLLOW-UP, THE CURRENT SURGEON REPORTED THAT THE CAUSE OF THE REFRACTIVE SURPRISE REMAINS UNK AND HE DOES NOT THINK LENS IS DEFECTIVE. HE REPORTED THAT THE PT HAS UCVA AND BCVA 20/20 AND IS HAPPY WITH THE RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF IQ TORIC INTRAOCULAR LENS HQL ALCON RESEARCH, LTD./HUNTINGTON SN6AT3 10920474

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Other