BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACRYSOF

    MDR report key: 1940058 · Received December 22, 2010

    Report

    Report Number
    1119421-2010-01489
    Event Type
    Malfunction
    Date Received
    December 22, 2010
    Report Date
    October 12, 2010
    Manufacturer
    ALCON RESEARCH LTD/HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    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. NO FURTHER INFORMATION IS EXPECTED. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT AN INTRAOCULAR LENS (IOL) SEEMED OPACIFIED IN THE POSTERIOR PART AND CLEAR IN THE ANTERIOR PART. NO FURTHER INFORMATION IS EXPECTED.

    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