BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF RESTOR

    MDR report key: 2230612 · Received August 12, 2011

    Report

    Report Number
    1119421-2011-00992
    Event Type
    Injury
    Date Received
    August 12, 2011
    Date of Event
    January 1, 2011
    Report Date
    July 16, 2011
    Manufacturer
    ALCON RESEARCH, LTD. / HUNTINGTON
    Product Code
    MFK
    PMA / PMN Number
    P040020
    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. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. AT THE CONSUMER'S REQUEST, THE SURGEON WAS NOT CONTACTED. (B)(4).

    Description of Event or Problem · 1

    A CONSUMER REPORTED THAT FOLLOWING BILATERAL INTRAOCULAR LENS [IOL] IMPLANT SURGERIES, SHE SEES HALOS (YELLOW OR WHITE IN COLOR) AROUND HEADLIGHTS AS SHE WAS TOLD TO BE EXPECT; HOWEVER, SHE ALSO SEES A TURQUOISE/BLUE SHADOW OR GHOSTING AROUND LIGHTER OBJECTS AND A GRAY COLOR AROUND DARKER OBJECTS. SHE STATED THAT IT IS "SO BAD" THAT SHE SEES THE BACK OF A CAR AS A BLUE "GHOST" CAR FOLLOWING A REAL CAR AND IT IS AS IF A PERSON WEARING A WHITE SHIRT LOOKS LIKE THEY ARE GLOWING WITH A TURQUOISE BORDER HALF THE SIZE OF HIS ARM SURROUNDING HIM. SHE STATED THAT OBJECTS THAT ARE CLOSER ALSO HAVE A TURQUOISE BORDER, ONLY SMALLER. SHE STATED THAT SHE READS VERY WELL WITH THE LENSES. IN A FOLLOW-UP, THE CONSUMER REPORTED HER SURGEON INFORMED HER THAT SHE NEEDS TO GIVE MORE TIME FOR HER BRAIN TO ADJUST TO THE LENSES. AT THE CONSUMER'S REQUEST, THE SURGEON WAS NOT CONTACTED. 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 RESTOR INTRAOCULAR LENS MFK ALCON RESEARCH, LTD. / HUNTINGTON SN6AD1 10955052

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other ARTIFICIAL TEARS PRN