BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF IQ TORIC

    MDR report key: 2163609 · Received June 8, 2011

    Report

    Report Number
    1119421-2011-00702
    Event Type
    Other
    Date Received
    June 8, 2011
    Date of Event
    April 1, 2011
    Report Date
    May 9, 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
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    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: 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. AT THE REQUEST OF THE CONSUMER, THE SURGEON WAS NOT CONTACTED. (B)(4).

    Description of Event or Problem · 1

    A CONSUMER REPORTED THAT ONE MONTH FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY, SHE SEES A SLIGHT SHADOW AND HAS BLURRINESS AT DISTANCES. SHE DOES NOT FEEL HER VISION IS AS SHARP AS IT SHOULD BE. THE CONSUMER REPORTED COLORS ARE BEAUTIFUL AND SHE CAN SEE MUCH BETTER UP CLOSE. THE CONSUMER REPORTED SHE WAS DISAPPOINTED AND DID NOT FEEL HER SYMPTOMS WERE GOING TO CLEAR UP. AT THE REQUEST OF THE CONSUMER, THE SURGEON WAS NOT CONTACTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF IQ TORIC INTRAOCULAR LENS HQL ALCON RESEARCH, LTD. / HUNTINGTON SN6AT4 10989376

    Patients

    Seq Age Sex Outcome Treatment
    1 Other