BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF RESTOR

    MDR report key: 2060894 · Received March 18, 2011

    Report

    Report Number
    1119421-2011-00307
    Event Type
    Other
    Date Received
    March 18, 2011
    Date of Event
    January 1, 2011
    Report Date
    February 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
    WA, 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 IDENTIFIED BY THE INVESTIGATION. THE SAMPLE WAS NOT 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 SIMILAR 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, HIS DISTANCE VISION IS IMPROVED BUT HIS NEAR VISION IS WORSE. THIS PREVENTS HIM FROM SEEING THE TV CLEARLY OR READ THE PAPER. HE ALSO REPORTED THAT HIS VISION IN LOW LIGHT CONDITION IS REDUCED. IN A FOLLOW-UP, THE CONSUMER FURTHER MENTIONED THAT HE "LOST HALF OF HIS VISION THAT HE HAD BEFORE SURGERY" AND THAT HIS INTERMEDIATE VISION IS FAIR TO POOR. HE ALSO INQUIRED ABOUT THE AVERAGE ADAPTATION TIME FOR THE MODEL LENS. 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 FIRST EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF RESTOR INTRAOCULAR LENS MFK ALCON RESEARCH, LTD. / HUNTINGTON SN6AD1 10982297

    Patients

    Seq Age Sex Outcome Treatment
    1 Other