BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNSPECIFIED LENS CARE PRODUCT

    MDR report key: 720216 · Received May 24, 2006

    Report

    Report Number
    1610287-2006-00007
    Event Type
    Injury
    Date Received
    May 24, 2006
    Report Date
    April 10, 2006
    Manufacturer
    ALCON LABORATORIES, INC.
    Product Code
    LPN
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PER CDC MMWR DISPATCH ISSUED IN 2006, 5 PATS WITH SUSPECTED FUSARIUM KERATITIS REPORTED USING OTHER SOLUTIONS IN ADDITION TO A RENU BRAND SOLUTION, INCLUDING SOLUTIONS MADE BY ADVANCED MED OPTICS, INC AND ALCON. ON THE SAME DAY, CDC MEDIA RELATIONS ISSUED A RELEASE THAT AS ONE MONTH LATER CDC HAS COMPLETE DATA FOR 98 OF 106 CONFIRMED CASES. THESE 98 CONFIRMED CASES INCLUDE 4 CASES REPORTING USE OF ANY ALCON PRODUCT (SOME CASES REPORTED USING MORE THAN ONE TYPE OF SOLUTION. NO CASE SPECIFIC DATA HAS BEEN PROVIDED TO ALCON, THEREFORE ALCON CANNOT CONFIRM IT THESE CASES HAVE BEEN PREVIOUSLY REPORTED. FUSARIUM KERATITIS -- MULTIPLE STATES, 2006, MMWR APR 2006; 55 (14): 400-401. FUSARIUM KERATITIS UPDATE: CDC OFICE OF ENTERPRISE COMMUNICATION DIV OF MEDIA RELATIONS. MAY 2006.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNSPECIFIED LENS CARE PRODUCT LENS CARE DISINFECTING SOLUTIONS LPN ALCON LABORATORIES, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention