BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF RESTOR

    MDR report key: 2001111 · Received February 16, 2011

    Report

    Report Number
    1119421-2011-00128
    Event Type
    Other
    Date Received
    February 16, 2011
    Date of Event
    January 1, 2011
    Report Date
    January 17, 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
    OTHER

    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. ADD'L INFO WAS REQUESTED ON 01/25/2011 AND 02/14/2011 BY PHONE, FAX, AND MAIL. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT FOLLOWING BILATERAL INTRAOCULAR LENS (IOL) IMPLANT SURGERIES, THE PT IS EXPERIENCING BLURRY VISION AT ALL DISTANCES AND SEES GLARE AND HALOS AT NIGHT. HE STATED THAT THERE IS NO REFRACTIVE SURPRISE, WITH BOTH EYES HAVING BCVA OF 20/20 AND UCVA 20/30. HE STATED THAT GLASSES WITH ANTI-REFLECTIVE HAVE BEEN GIVEN TO THE PT, BUT THE SYMPTOMS PERSIST. THE SURGEON DOES NOT BELIEVE THE IOLS ARE DEFECTIVE, BUT HE DOES NOT KNOW THE CAUSE OF THE EVENTS. ADD'L INFO HAS BEEN REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS REPORT IS FOR THE LEFT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF RESTOR INTRAOCULAR LENS MFK ALCON RESEARCH, LTD./HUNTINGTON SN6AD1 10938166

    Patients

    Seq Age Sex Outcome Treatment
    1 Other