BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF RESTOR

    MDR report key: 1833857 · Received September 3, 2010

    Report

    Report Number
    1119421-2010-00975
    Event Type
    Other
    Date Received
    September 3, 2010
    Date of Event
    January 1, 2010
    Report Date
    August 4, 2010
    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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR ANALYSIS; THE DEVICE REMAINS IMPLANTED. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ADDITIONAL INFORMATION WAS REQUESTED ON 08/05/2010, 08/09/2010, 08/17/2010, AND 08/20/2010 BY PHONE, FAX, AND MAIL. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED. (B)(4).

    Description of Event or Problem · 1

    ADVERSE EVENT(S): "REFRACTIVE SURPRISE" (POSTOPERATIVE REFRACTION, UNEXPECTED); "VISION BLURRED" (BLURRED VISION); "EYE FATIGUE" (NO CODE AVAILABLE). PRODUCT PROBLEM(S): "NONE REPORTED" (NO INFORMATION [IOL (INTRAOCULAR LENS) IMPLANT]). A SURGEON REPORTED REFRACTIVE SURPRISES IN THREE BILATERAL AND ONE UNILATERAL PATIENTS FOLLOWING INTRAOCULAR LENS IMPLANT SURGERY. THIS PATIENT REPORTED THAT THE VISION WAS BLURRY AND WAS EXPERIENCING EYE FATIGUE. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE SEVEN MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS REPORT IS FOR THE LEFT EYE OF THE SECOND PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF RESTOR INTRAOCULAR LENS MFK ALCON RESEARCH, LTD. / HUNTINGTON SN6AD1 10872516

    Patients

    Seq Age Sex Outcome Treatment
    1 Other