BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF

    MDR report key: 2023603 · Received January 20, 2011

    Report

    Report Number
    1119421-2011-00054
    Event Type
    Other
    Date Received
    January 20, 2011
    Date of Event
    January 1, 2010
    Report Date
    December 21, 2010
    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
    OR, US
    Reporter Occupation
    PHYSICIST

    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 INFO WAS REQUESTED ON 01/11/2011 BY FAX AND MAIL. A COMPLETED QUESTIONNAIRE WAS RECEIVED ON 01/13/2011. (B)(4).

    Description of Event or Problem · 1

    A CONSUMER (PHYSICIST) REPORTED THAT FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY, HE NOTICED THAT THERE IS A DIFFERENCE IN RECEPTION (WITH THE IMPLANTED EYE) WHEN A VIOLET LASER IS IN USE AND WAS INQUIRING HOW THE IOL ABSORBS DIFFERENT WAVELENGTHS. IN A FOLLOW-UP, THE SURGEON REPORTED THAT THE PROBABLE CAUSE IS THE YELLOW TINT OF THE IOL. HE REPORTED THE PT HAS A NUMBER OF OCULAR PRE-EXISTING CONDITIONS, SUCH AS HOMONYMOUS HEMIANOPSIA, TRANSIENT VISUAL HALLUCINATIONS, OPTICAL ISCHEMIC STROKE, AND VISUAL MIGRAINE. THE SURGEON REPORTED THAT NO MEDICAL OR SURGICAL INTERVENTION WAS PERFORMED TO TREAT THE EVENT; AND THAT IT IS UNK IF THE EVENT CONTINUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRAOCULAR LENS HQL ALCON RESEARCH, LTD./HUNTINGTON SN60WF 10963021

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other MONARCH DELIVERY SYSTEM| DISCOVISC