BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTI-FREE EXPRESS MULTI-PURPOSE DISINFECTING SOLUTION

    MDR report key: 19341969 · Received May 17, 2024

    Report

    Report Number
    1610287-2024-00025
    Event Type
    Injury
    Date Received
    May 17, 2024
    Date of Event
    April 22, 2024
    Report Date
    August 12, 2024
    Manufacturer
    ALCON RESEARCH, LLC
    Product Code
    LPN
    PMA / PMN Number
    K021143
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE LOT NUMBER WAS NOT PROVIDED AND THE COMPLAINT SAMPLE WAS NOT MADE AVAILABLE FOR EVALUATION. THE MANUFACTURING REVIEW DID NOT INDICATE THAT THIS COMPLAINT WAS DUE TO THE MANUFACTURING PROCESS. NO COMPLAINT OR MANUFACTURING TREND WAS IDENTIFIED. THE ROOT CAUSE COULD NOT BE DETERMINED. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 0

    H.3., H.6.: THE COMPLAINT SAMPLE HAS NOT RETURNED FOR EVALUATION; THE LOT NUMBER IS UNKNOWN. INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. ALICE Y. MATOBA, MD,JEFF R. PETERSON, MD, KIRK R. WILHELMUS. DENDRITIFORM KERATOPATHY ASSOCIATED WITH EXPOSURE TO POLYQUARTERNIUM-1, A COMMON OPHTHALMIC PRESERVATIVE. AMERICAN ACADEMY OF OPHTHALMOLOGY 2016; 123, 451-456. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 0

    AS REPORTED IN THE LITERATURE OUT OF SIXTEEN CONSUMERS, TWELVE CONSUMERS WERE EXPOSURE TO CONTACT LENS CARE DISINFECTING SOLUTION CONTAINING POLYQUATERNIUM-1. THE ACTUAL CONTACT LENS CARE DISINFECTING SOLUTIONS ASSOCIATED WITH THE EVENT IS NOT KNOWN, THEREFORE AS PER THE ARTICLE UNSPECIFIED CONTACT LENS CARE DISINFECTING SOLUTIONS CONSIDERED AS A SUSPECT PRODUCT. THIS COMPLAINT REFERS TO ONE OF THE CONSUMERS OUT OF TWELVE, WHO WAS EXPOSED CONTACT LENS CARE DISINFECTING SOLUTION CONTAINING POLYQUATERNIUM-1 AND WAS IN USE WITH DAILY CONTACT LENS FOR BOTH EYES AND EXPERIENCED BILATERAL DENDRITIFORM KERATOPATHY. CONTACT LENS SOLUTION WAS DISCONTINUED. THE CURRENT STATUS OF THE CONSUMER'S EYE WAS RESOLVED (FIVE WEEKS OF DURATION) AT THE TIME OF THIS REPORT. NO ADDITIONAL INFORMATION REQUESTED DUE TO THE UNLIKELIHOOD OF OBTAINING ADDITIONAL INFORMATION FROM LITERATURE ARTICLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    971993 OPTI-FREE EXPRESS MULTI-PURPOSE DISINFECTING SOLUTION ACCESSORIES, SOFT LENS PRODUCTS LPN ALCON RESEARCH, LLC NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Female Other UNSPECIFIED CONTACT LENS