BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF RESTOR

    MDR report key: 2073581 · Received April 27, 2011

    Report

    Report Number
    1119421-2011-00489
    Event Type
    Injury
    Date Received
    April 27, 2011
    Date of Event
    February 1, 2011
    Report Date
    March 28, 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
    AZ, US
    Reporter Occupation
    UNKNOWN

    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. THE PRODUCT WAS NOT RETURNED. PT HAS INDICATED THAT THEIR VISION IS GOOD WITH THEIR INTERMEDIATE VISION GETTING BETTER. PT DOES NOT FEEL THERE IS ANYTHING WRONG WITH THE LENSES. PT HAS ALWAYS BEEN SENSITIVE TO LIGHT AND HAS ALWAYS HAD TO WEAR SUNGLASSES. 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 HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. AT THE REQUEST OF THE CONSUMER, THE SURGEON WAS NOT CONTACTED. (B)(4).

    Description of Event or Problem · 1

    A CONSUMER REPORTED THAT FOLLOWING BILATERAL INTRAOCULAR LENS (IOL) IMPLANT SURGERY, SHE SEES REFLECTION FROM ALL BRIGHT SURFACES AND CAN SEE, MOST LIKELY THE LENS ITSELF. SHE REPORTED SHE CAN "PROJECT" A CIRCULAR FORM MUCH LIKE A BULLSEYE MADE UP OF A CIRCLE OF LINES MADE UP OF SMALL DOTS. SHE IS HAVING DIFFICULTY DRIVING AT NIGHT DUE TO GETTING GLARE FROM ANYTHING THAT'S SHINY. IN A FOLLOW UP PHONE CALL, THE CONSUMER REPORTED HER SURGEON WAS TREATING HER WITH MEDICATIONS TO USE BEFORE SHE DRIVES AND SUGGESTED THAT SHE WEAR SUNGLASSES AT NIGHT. SHE HAD NOT PICKED THIS PRESCRIPTION UP FROM THE PHARMACY. THE CONSUMER ALSO REPORTED HER SURGEON WAS TREATING HER WITH MEDICATIONS FOR DRY EYES. THE MEDICATIONS FOR DRY EYES DID SEEM TO BE HELPING. THE CONSUMER REPORTED HER VISION WAS GOOD WITH HER INTERMEDIATE VISION GETTING BETTER. SHE DOES NOT FEEL THERE IS ANYTHING WRONG WITH THE LENSES. THE CONSUMER REPORTED SHE HAS ALWAYS BEEN SENSITIVE TO LIGHT AND HAD TO WEAR SUNGLASSES. SHE ALSO REPORTED HAVING HYPERTENSION AND ALLERGIES. AT THE REQUEST OF THE CONSUMER, THE SURGEON WAS NOT CONTACTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS REPORT IS FOR THE LEFT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF RESTOR INTRAOCULAR LENS MFK ALCON RESEARCH, LTD. / HUNTINGTON SN6AD1 11019256

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention CLARITAN| REFRESH ARTIFICIAL TEARS| BENICAR| UNKNOWN DROP