BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRSYOF

    MDR report key: 1047305 · Received May 16, 2008

    Report

    Report Number
    1119421-2008-00311
    Event Type
    Injury
    Date Received
    May 16, 2008
    Date of Event
    January 1, 2008
    Report Date
    April 16, 2008
    Manufacturer
    ALCON RESEARCH, LTD.
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    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. ADDITIONAL INFO WAS REQUESTED 04/18/2008, 04/29/2008 AND 05/07/2008 BY PHONE, MAIL AND FAX. ADDITIONAL INFO WAS RECEIVED 04/18/2008 AND 04/29/2008 BY PHONE. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED.

    Description of Event or Problem · 1

    A SURGEON TRAVELED TO ANOTHER COUNTRY TO PERFORM INTRAOCULAR LENS (IOL) IMPLANT SURGERY. THREE MONTHS FOLLOWING THE SURGERY, THE PT REPORTED SEEING A LINE ACROSS THE VISUAL FIELD. THE LENS WAS EXCHANGED FOR A DIFFERENT MODEL. ADDITIONAL INFO HAS BEEN REQUESTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention