BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTI-FREE PUREMOIST MPDS

    MDR report key: 2833703 · Received November 12, 2012

    Report

    Report Number
    1610287-2012-00127
    Event Type
    Injury
    Date Received
    November 12, 2012
    Date of Event
    January 1, 2012
    Report Date
    October 11, 2012
    Manufacturer
    ALCON - FORT WORTH/ ALCON LABORATORIES. INC.
    Product Code
    LPN
    PMA / PMN Number
    K102860
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. THE PRODUCT HISTORY RECORDS COULD NOT BE REVIEWED BECAUSE THE REPORTER DID NOT PROVIDE A LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MANUFACTURING DOCUMENTATION. THE PRODUCT INVESTIGATION COULD NOT IDENTIFY A ROOT CAUSE. NOT ENOUGH INFORMATION WAS PROVIDED FROM THE ACCOUNT TO PROPERLY COMPLETE AN INVESTIGATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED. (B)(4).

    Description of Event or Problem · 1

    AN OPTOMETRIST REPORTED PATIENTS WITH CORNEAL ULCERS "POTENTIALLY RELATED" TO THE USE OF PRODUCT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPTI-FREE PUREMOIST MPDS LENS CARE DISINFECTING SOLUTIONS LPN ALCON - FORT WORTH/ ALCON LABORATORIES. INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other