BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF

    MDR report key: 2161832 · Received July 8, 2011

    Report

    Report Number
    1119421-2011-00850
    Event Type
    Injury
    Date Received
    July 8, 2011
    Date of Event
    January 1, 2011
    Report Date
    June 8, 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
    MD, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVALUATION: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS, ONLY THE CARTON AND INSERTS WERE RETURNED. 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. THE REPORTER DID NOT PROVIDE ANY SURGEON CONTACT INFORMATION; THEREFORE FOLLOW UP WAS NOT ABLE TO BE CONDUCTED. ADDITIONAL INFORMATION WAS REQUESTED ON 06/09/2011 BY EMAIL. ADDITIONAL INFORMATION WAS RECEIVED FROM THE PATIENT VIA EMAIL ON 06/12/2011. (B)(4).

    Description of Event or Problem · 1

    TWO YEARS FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY, A CONSUMER REPORTED THAT SHE STILL HAS SEVERE PAIN, INFLAMMATION AND LIGHT SENSITIVITY. THE CONSUMER REPORTED THAT SHE WAS TOLD HER EYE HAD "HEALED," BUT HER SYMPTOMS PERSIST. SHE HAS HAD TESTS FOR OTHER MEDICAL CONDITIONS THAT MIGHT BE CONTRIBUTING TO THE INFLAMMATION IN HER EYE, BUT THESE WERE ALL NEGATIVE. THE CONSUMER REPORTED THAT SHE HAS BEEN REFERRED TO A NUMBER OF SPECIALISTS WHO CANNOT DETERMINE WHAT IS CAUSING HER INFLAMMATION. SHE IS CURRENTLY SCHEDULED TO SEE ANOTHER PHYSICIAN IN CONSULTATION. THE REPORTER DID NOT PROVIDE ANY SURGEON CONTACT INFORMATION; THEREFORE, FOLLOW UP WAS NOT ABLE TO BE CONDUCTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRAOCULAR LENS HQL ALCON RESEARCH, LTD. / HUNTINGTON MA60AC 10744322

    Patients

    Seq Age Sex Outcome Treatment
    1 Other