BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF RESTOR

    MDR report key: 2023724 · Received February 18, 2011

    Report

    Report Number
    1119421-2011-00178
    Event Type
    Other
    Date Received
    February 18, 2011
    Date of Event
    June 14, 2010
    Report Date
    January 20, 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
    CA, 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: NO ROOT CAUSE COULD BE IDENTIFIED BY THE INVESTIGATION. NO SAMPLE WAS RETURNED. ACTION TAKEN: NO FURTHER ACTION IS WARRANTED AT THIS TIME. COMPLAINT TRENDS WILL CONTINUE TO BE MONITORED AND FURTHER ACTION WILL BE INITIATED WHEN DEEMED NECESSARY BY THE APPROPRIATE RESPONSIBLE MANAGEMENT PERSONNEL. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ADDITIONAL INFORMATION WAS REQUESTED ON 01/24/2011, 01/26/2011, 02/10/2011, AND 02/15/2011 BY PHONE, FAX, AND MAIL. A COMPLETED QUESTIONNAIRE WAS RECEIVED ON 02/11/2011. (B)(4).

    Description of Event or Problem · 1

    A CONSUMER'S HUSBAND REPORTED THAT FOLLOWING BILATERAL INTRAOCULAR LENS (IOL) IMPLANT SURGERY, HIS WIFE HAS DOUBLE VISION. THE HUSBAND REPORTED THAT HIS WIFE SEES DOUBLE WITH BOTH EYES OPEN OR JUST THE LEFT EYE OPEN, BUT NOT WITH THE RIGHT EYE OPEN. THE DOUBLE VISION VARIES AS SHE CAN "PULL IT IN", BUT IS WORSE UPON UP-GAZE. THE HUSBAND REPORTED HIS WIFE HAS BEEN TOLD SHE HAS ASTIGMATISM AND THIS IS PROBABLY THE CAUSE OF HER DOUBLE VISION. IN A FOLLOW-UP, THE SURGEON REPORTED THE IOLS DID NOT CAUSE/CONTRIBUTE TO THE EVENT. HE REPORTED THE PATIENT WAS NOTED TO HAVE STRABISMUS POSTOPERATIVELY. THE SURGEON ALSO REPORTED THE PATIENT TAKES ANTI-ANXIETY MEDICATION AND NARCOTICS AND BELIEVES THAT ONE OR MORE OF THESE MEDICATIONS MIGHT BE IMPAIRING FUSION. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. 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 10940010

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other TRANXENE| MONARCH DELIVERY SYSTEM| TYLENOL #3| NORCO