BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF

    MDR report key: 2231178 · Received August 26, 2011

    Report

    Report Number
    1119421-2011-01049
    Event Type
    Injury
    Date Received
    August 26, 2011
    Date of Event
    July 28, 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
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    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 DETERMINED FROM 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 HAS BEEN REQUESTED. (B)(4).

    Description of Event or Problem · 1

    A STUDY COORDINATOR REPORTED A STUDY PATIENT WITH BLURRED VISION, DISTORTION AND DOUBLE VISION FOLLOWING BILATERAL INTRAOCULAR LENS (IOL) IMPLANT SURGERIES. THE SURGEON REPORTED THAT THESE EVENTS ARE NOT RELATED TO THE STUDY DEVICE, BUT A RESIDUAL REFRACTIVE ERROR AFTER SURGERY. THE SURGEON ALSO REPORTED THE PATIENT EXPERIENCED A CHANGE IN BRIGHTNESS FOLLOWING THE PROCEDURE. THIS EVENT IS NOT RELATED TO THE STUDY DEVICE, BUT IS CAUSED BY READING GLASSES THAT BLOCK THE LIGHT. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THESE EVENTS; THIS REPORT IS FOR THE RIGHT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRAOCULAR LENS HQL ALCON RESEARCH, LTD. / HUNTINGTON SN60WF 12031381

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Other XALATAN| ETODOLAC| LOSARTAN| PRAMIPEXOL| BABY ASPIRIN| FUROSEMIDE| SKELAXIN| LIPITOR| TIMOLOL