BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN CONTACT LENS CARE SOLUTION

    MDR report key: 7932101 · Received October 3, 2018

    Report

    Report Number
    1610287-2018-00039
    Event Type
    Injury
    Date Received
    October 3, 2018
    Report Date
    November 5, 2018
    Manufacturer
    ALCON LABORATORIES, INC.
    Product Code
    LPN
    PMA / PMN Number
    UNKNOWN
    Removal / Correction Number
    CORRECTION
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    H.3., H.6.: 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

    FOR MANUFACTURING SITE REGISTRATION NUMBER 1610287, CORRECTED THE MANUFACTURING REPORT NUMBER TO 1610287-2018-00039 FROM 8020392-2018-00003. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 0

    FOR MANUFACTURING SITE REGISTRATION NUMBER (B)(4), CORRECTED THE MANUFACTURING REPORT NUMBER TO 1610287-2018-00039 FROM 1422160-2018-00003. . THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 1

    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. THIS REPORT ORIGINALLY FILED AS 8020392-2018-00003. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 1

    AS DOCUMENTED IN A LITERATURE JOURNAL PUBLICIZED ON (B)(6) 2009, THERE WAS ONE CASE OF CORNEAL EROSION REPORTED IN RELATION TO BOTH THE CONTACT LENS AND THE CONTACT LENS CARE PRODUCT. SINCE THE ADVERSE EVENT WAS NOTED FROM A LITERATURE REPORT, ADDITIONAL INFORMATION CAN NOT BE OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    773311 UNKNOWN CONTACT LENS CARE SOLUTION ACCESSORIES, SOFT LENS PRODUCTS LPN ALCON LABORATORIES, INC. NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other