BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF RESTOR

    MDR report key: 1941922 · Received December 22, 2010

    Report

    Report Number
    1119421-2010-01467
    Event Type
    Other
    Date Received
    December 22, 2010
    Date of Event
    November 22, 2010
    Report Date
    December 3, 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
    TX, 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. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED A STUDY PATIENT EXPERIENCING HALOS, HAZY VISION, AND SHADOWS FOLLOWING BILATERAL INTRAOCULAR LENS (IOL) IMPLANT SURGERIES. THE SURGEON REPORTED THE PATIENT'S DESCRIPTION OF THE SYMPTOMS AS FOLLOWS; HALOS WERE PRE-EXISTING AND STILL CONTINUE AFTER SURGERY; THE HAZY VISION IS NOTICEABLE "FIRST THING IN THE MORNING BUT GOES AWAY AS THE MORNING GOES ON" AND IS BEING TREATED WITH MEDICATION, ATTRIBUTED TO DRY EYE; LATERAL SHADOW WAS SEEN SINCE THE NIGHT AFTER SURGERY, BUT IS DIMINISHING AND "ALMOST COMPLETELY GONE". THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THESE EVENTS. 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 11022509

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other LOTEMAX