BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF IQ TORIC

    MDR report key: 2011838 · Received February 25, 2011

    Report

    Report Number
    1119421-2011-00200
    Event Type
    Other
    Date Received
    February 25, 2011
    Date of Event
    January 1, 2011
    Report Date
    January 28, 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
    FL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVAL: 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 MGMT PERSONNEL. 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 HAS POOR DISTANCE VISION AND CANNOT SEE UP CLOSE IN HER RIGHT EYE. SHE REPORTED THE RIGHT EYE WAS SUPPOSED TO BE FOR NEAR VISION AND HER LEFT FOR DISTANCE. SHE REPORTED THAT SHE HAS SEEN THREE DIFFERENT OPTOMETRISTS IN THE PRACTICE AND THEY ALL SAID THEY COULD NOT SEE THE "ARMS" OF THE LENS. 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 RIGHT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF IQ TORIC INTRAOCULAR LENS HQL ALCON RESEARCH, LTD./HUNTINGTON SN6AT5 11031957

    Patients

    Seq Age Sex Outcome Treatment
    1 Other