BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF

    MDR report key: 862847 · Received June 8, 2007

    Report

    Report Number
    1119421-2007-00239
    Event Type
    Injury
    Date Received
    June 8, 2007
    Date of Event
    January 1, 2007
    Report Date
    May 8, 2007
    Manufacturer
    ALCON LABORATORIES, INC.
    Product Code
    HQL
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. PRODUCT HISTORY RECORDS COULD NOT BE REVIEWED BECAUSE THE REPORTING FACILITY DID NOT PROVIDE A LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MANUFACTURING DOCUMENTATION. ADDITIONAL INFORMATION WAS REQUESTED 05/09/2007, 05/11/2007, 05/13/2007, 05/25/2007 AND 05/29/2007 BY PHONE, MAIL AND FAX. ADDITIONAL INFORMATION WAS PROVIDED 05/10/2007 BY PHONE. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED.

    Description of Event or Problem · 1

    A SURGEON REPORTS THAT FOLLOWING INTRAOCULAR LENS (IOL) SURGERY, A PATIENT REPORTED BLURRY NEAR AND DISTANCE VISION. THE LENS WAS EXPLANTED. ADDITIONAL INFORMATION, INCLUDING PATIENT STATUS, HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRAOCULAR LENS HQL ALCON LABORATORIES, INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NI YR Required Intervention