BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF

    MDR report key: 2023690 · Received February 18, 2011

    Report

    Report Number
    1119421-2011-00140
    Event Type
    Other
    Date Received
    February 18, 2011
    Date of Event
    January 1, 2010
    Report Date
    January 19, 2011
    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
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVALUATION: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. PRODUCT HISTORY RECORDS COULD NOT BE REVIEWED BECAUSE THE REPORTER DID NOT PROVIDE A LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MANUFACTURING DOCUMENTATION. ROOT CAUSE: NO SERIAL NUMBER OR SAMPLE WAS PROVIDED BY THE CUSTOMER. NO ROOT CAUSE CAN BE DETERMINED AT THIS TIME. ACTION TAKEN: NO FURTHER ACTION IS WARRANTED AT THIS TIME. COMPLAINT TRENDS WILL CONTINUE TO BE MONITORED AND FURTHER ACTION WILL BE INITIATED WHEN DEEMED NECESSARY BY THE APPROPRIATE RESPONSIBLE MANAGEMENT PERSONNEL. ADDITIONAL INFORMATION HAS BEEN REQUESTED. (B)(4).

    Description of Event or Problem · 1

    A COMPLIANCE OFFICER REPORTED (B)(4) CASES OF "REFRACTILE INCLUSIONS" TERMED AS GLISTENINGS. THE GLISTENINGS ARE REPORTED TO BE AFFECTING THE QUALITY AND AMOUNT OF VISION IN THE PTS INVOLVED. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE (B)(4) MEDICAL DEVICE REPORTS ASSOCIATED WITH THESE EVENTS; THIS IS THE SIXTH CASE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other