BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF RESTOR

    MDR report key: 1822548 · Received August 27, 2010

    Report

    Report Number
    1119421-2010-00943
    Event Type
    Injury
    Date Received
    August 27, 2010
    Report Date
    July 29, 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
    GR
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR ANALYSIS; DEVICE REMAINS IMPLANTED. PRODUCT HISTORY RECORDS COULD NOT BE REVIEWED BECAUSE THE REPORTER DID NOT PROVIDE A LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MANUFACTURING DOCUMENTATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED. (B)(4).

    Description of Event or Problem · 1

    ADVERSE EVENT(S): "BLURRED VISION" (BLURRED VISION). PRODUCT PROBLEM(S): "NONE REPORTED" (NO INFORMATION [IOL (INTRAOCULAR LENS) IMPLANT]). A CONSUMER'S DAUGHTER REPORTED THAT FOLLOWING BILATERAL INTRAOCULAR LENS (IOL) IMPLANT SURGERIES, HER MOTHER IS EXPERIENCING BLURRED VISION. SHE REPORTED THAT DUE TO THE BLURRED VISION, HER MOTHER HAD LASIK PERFORMED ON ONE EYE. THE BLURRED VISION PERSISTED AND SUBSEQUENTLY, A "POSTERIOR CHAMBER CAPSULAR BAG CLEARANCE" WAS ALSO PERFORMED. SHE STATED THAT HER MOTHER'S BLURRED PERSISTS. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS REPORT IS FOR THE FIRST EYE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention