BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF

    MDR report key: 1353566 · Received March 19, 2009

    Report

    Report Number
    1119421-2009-00228
    Event Type
    Other
    Date Received
    March 19, 2009
    Date of Event
    January 1, 2009
    Report Date
    February 17, 2009
    Manufacturer
    ALCON RESEARCH, LTD./HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    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. THIS REPORT WAS MAILED TO FDA ON: 03/19/2009.

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT HIS FELLOW SURGEON NOTED GLISTENINGS ON AN IMPLANTED INTRAOCULAR LENS (IOL). THE PATIENT ALSO REPORTED GLARE WHICH, ACCORDING TO THE REPORTING SURGEON, MAY BE RELATED TO CAPSULE STRESS FOLDS. IT WAS ALSO REPORTED THAT THERE IS NO DECREASE IN THE PATIENT'S VISUAL ACUITY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRAOCULAR LENS HQL ALCON RESEARCH, LTD./HUNTINGTON MA60AC NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Other