BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF

    MDR report key: 1063731 · Received June 20, 2008

    Report

    Report Number
    1119421-2008-00463
    Event Type
    Other
    Date Received
    June 20, 2008
    Date of Event
    January 1, 2008
    Report Date
    May 23, 2008
    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
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE ASSOCIATED WITH THIS REPORT HAS NOT BEEN REC'D FOR EVAL. PRODUCT HISTORY RECORDS COULD NOT BE REVIEWED, BECAUSE THE REPORTER HAS NOT PROVIDED A LOT NUMBER, OR ANY IDENTIFICATION TRACEABLE TO THE MFG DOCUMENTATION. ADD'L INFO WAS REQUESTED ON 05/30/2008, 06/02/2008 AND 06/04/2008 BY PHONE AND ON 06/02/2008 BY MAIL AND FAX. A COMPLETED QUESTIONNAIRE HAS NOT BEEN REC'D.

    Description of Event or Problem · 1

    A SURGEON REPORTED HE SEES GLISTENINGS IN THE INTRAOCULAR LENS (IOL) HE IMPLANTS. HE REPORTED THAT HE FEELS THEY COULD BE AFFECTING THE VISUAL ACUITY IN SOME OF THE PTS BY ONE OR TWO LINES. HE ALSO STATES WHEN HE EXAMINES A PT WHO HAS GLISTENINGS IN THE IOL IT BLURS THE FUNDUS. HE STATED HE DOES NOT HAVE A SPECIFIC PT OR A SPECIFIC LOT NUMBER TO REPORT AT THIS TIME. ADD'L INFO WAS REQUESTED BUT NOT RECD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRAOCULAR LENS HQL ALCON RESEARCH LTD / HUNTINGTON SN60WF UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other