BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF RESTOR

    MDR report key: 1063492 · Received June 20, 2008

    Report

    Report Number
    1119421-2008-00455
    Event Type
    Injury
    Date Received
    June 20, 2008
    Date of Event
    January 1, 2008
    Report Date
    April 11, 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 Location
    FR
    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 MANUFACTURING DOCUMENTATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    A CONSUMER REPORTED POOR VISION FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY IN HER RIGHT EYE. THE SURGEON STATED THERE WAS A BIOMETRIC CALCULATION ERROR. THE CONSUMER UNDERWENT A PRK PROCEDURE WHICH RESULTED IN NO IMPROVEMENT. FOLLOWING THE PRK PROCEDURE, SHE REPORTS SEEING HALOS AND PHOTOPHOBIA AND STATES SHE MUST BE VERY NEAR THE TELEVISION IN ORDER TO WATCH IT. THE CONSUMER HAS A HISTORY OF SLIGHT STRABISMUS IN 2006, BUT SHE DID NOT COMPLY WITH THE PHYSICIAN'S INSTRUCTIONS TO BLOCK HER EYE WITH AN OPAQUE FILM ON HER GLASSES. SHE STATES THE INSTRUCTIONS WERE TOO CONSTRICTING. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF RESTOR INTRAOCULAR LENS MFK ALCON RESEARCH, LTD. / HUNTINGTON SA60D3 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention VISMED (SODIUM HYALURONATE)