BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF RESTOR

    MDR report key: 1081319 · Received July 24, 2008

    Report

    Report Number
    1119421-2008-00554
    Event Type
    Injury
    Date Received
    July 24, 2008
    Date of Event
    January 1, 2008
    Report Date
    June 24, 2008
    Manufacturer
    ALCON RESEARCH,, LTD./HUNTINGTON
    Product Code
    MFK
    PMA / PMN Number
    P040020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE ASSOCIATED WITH THIS REPORT HAS NOT BEEN RECEIVED FOR EVALUATION. PRODUCT HISTORY RECORDS COULD NOT BE REVIEWED BECAUSE THE REPORTER DID NOT PROVIDE A LENS SERIAL NUMBER, LOT NUMBER, OR ANY IDENTIFICATION TRACEABLE TO THE MFG DOCUMENTATION. NO ADDITIONAL INFORMATION WAS PROVIDED TO ALLOW FOR A FOLLOW-UP.

    Description of Event or Problem · 1

    AN FDA MEDWATCH REPORT WAS RECEIVED. A CONSUMER REPORTED THAT, A FEW WEEKS AFTER AN INTRAOCULAR LENS (IOL) IMPLANT SURGERY, MAJOR FLOATERS STARTED BLURRING VISION IN ONE EYE. THE CONSUMER WAS DIAGNOSED WITH A DETACHING RETINAL LINING. THE CONSUMER FURTHER REPORTS THAT THE PHYSICAL EFFECTS ARE DEPRESSING, BRIGHT LIGHTS CAUSE DISCOMFORT, EYES GET REALLY TIRED, AND THERE APPEARS TO BE INFLAMMATION. THERE WAS NO FURTHER INFO PROVIDED TO ALLOW FOR A FOLLOW-UP.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other