BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF

    MDR report key: 2034722 · Received March 23, 2011

    Report

    Report Number
    1119421-2011-00313
    Event Type
    Other
    Date Received
    March 23, 2011
    Date of Event
    February 16, 2011
    Report Date
    February 21, 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
    NC, 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 DETERMINED. THE PRODUCT 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 COMPLAINTS REPORTED IN THE LOT NUMBER. ADD'L INFO REC'D IN A F/U PHONE CALL ON 02/25/2011. (B)(4).

    Description of Event or Problem · 1

    A CONSUMER REPORTED SEEING LIGHT FLASHES TO THE RIGHT SIDE OF HIS EYE AFTER HAVING HIS EYE PRESSURE CHECKED AND EYES DILATED AT AN EYE EXAMINATION. THE CONSUMER REPORTED IT WAS LIKE SEEING A REFLECTION OF THE INTRAOCULAR LENS (IOL) AND AS IF THE LENS WAS FLOATING AROUND. THE CONSUMER INDICATED THE TECHNICIAN USED A BLUE LIGHT TO DO HIS PRESSURE CHECK AND HE FEELS THE IOL MAY HAVE MOVED AFTER THE TECHNICIAN TAPPED HIS EYE SEVERAL TIMES WHILE DOING THE PRESSURE CHECK. AT THE TIME OF HIS REPORT, THE CONSUMER REPORTED THE LIGHT FLASHES WERE LESS NOTICEABLE, BUT THE EYE FELT DRY AND HIS VISION WAS LESS CLEAR. THE CONSUMER REPORTED HE HAD STATED USING MOISTURE DROPS IN HIS EYES. IN A F/U PHONE CALL WITH THE CONSUMER, HE REPORTED HE HAD SEEN THIS SURGEON IN A F/U VISIT. THE SURGEON HAD TOLD HIM THERE WAS NOTHING OUT OF THE ORDINARY IN THE EXAMINATION AND FELT THE CONSUMER WAS SEEING SOME VITREOUS. THE CONSUMER REPORTED HE STILL SEES THE "FLOATERS" WHICH HE CAN SEE WHEN HE LOOKS TO THE RIGHT, LEFT OR WHEN READING. HE STATED HE NEVER HAD THEM UNTIL THE DILATED EXAMINATION. AT THE REQUEST OF THE CONSUMER, THE SURGEON WAS NOT CONTACTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRAOCULAR LENS HQL ALCON RESEARCH. LTD. / HUNTINGTON SN60WF 10937114

    Patients

    Seq Age Sex Outcome Treatment
    1 Other