BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAILIES COLORS

    MDR report key: 24220207 · Received January 30, 2026

    Report

    Report Number
    9610813-2026-00004
    Event Type
    Injury
    Date Received
    January 30, 2026
    Date of Event
    December 21, 2025
    Report Date
    April 8, 2026
    Manufacturer
    CIBA VISION GMBH
    Product Code
    LPL
    UDI-DI
    00730822251136
    PMA / PMN Number
    K190045
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H.3., H.6.: THE COMPLAINT SAMPLE HAS NOT RETURNED FOR EVALUATION. 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 IS THE THIRD OF FOUR REPORTS FOR THE SAME PATIENT INVOLVING FOUR LOT NUMBERS OF THE SAME PRODUCT. IT IS UNKNOWN WHICH CONTRIBUTED TO THE EVENT. REFER TO THE OTHER REPORT FILED UNDER THE MANUFACTURER'S INTERNAL REFERENCE NUMBER OF (B)(4) (FIRST REPORT), (B)(4) (SECOND REPORT) AND (B)(4) (FOURTH REPORT).¿ THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4). H.10 REFLECTS ALL RELATED REPORT NUMBERS ASSOCIATED WITH THIS PRODUCT EVENT THAT HAVE BEEN SUBMITTED AT THIS TIME.

    Additional Manufacturer Narrative · 0

    H.3., H.6.: THE ACTUAL COMPLAINT PRODUCT WAS NOT RETURNED FOR EVALUATION. THE DEVICE HISTORY RECORD AND STERILIZATION RECORD FOR THIS LOT HAVE BEEN REVIEWED AND FOUND TO BE IN COMPLIANCE. THERE WAS NO NONCONFORMITY OR DEVIATIONS DURING THE MANUFACTURING PROCESS WHICH RELATED TO THE NATURE OF THE COMPLAINT. A TREND RELATED INVESTIGATION WAS PERFORMED; NO TREND COULD BE IDENTIFIED. THE ROOT CAUSE COULD NOT BE DETERMINED. THIS IS THE THIRD OF FOUR REPORTS FOR THE SAME PATIENT INVOLVING FOUR LOT NUMBERS OF THE SAME PRODUCT. IT IS UNKNOWN WHICH CONTRIBUTED TO THE EVENT. REFER TO THE OTHER REPORT FILED UNDER THE MFG REPORT NUMBER OF 9610813-2026-00003, 9610813-2026-00005 AND 9610813-2026-00006. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4). H.10 REFLECTS ALL RELATED REPORT NUMBERS ASSOCIATED WITH THIS PRODUCT EVENT THAT HAVE BEEN SUBMITTED AT THIS TIME.

    Description of Event or Problem · 0

    AS INITIALLY REPORTED BY THE CONSUMER, THEY EXPERIENCED PAIN AND WERE UNABLE TO REMOVE THE CONTACT LENS, WHICH BROKE INTO PIECES INSIDE THEIR RIGHT EYE. THE CONSUMER SOUGHT CARE FROM AN OPHTHALMOLOGIST BECAUSE THE LENS CAUSED A DEEP CUT THAT NEARLY AFFECTED THE RETINAL AREA. THE CONSUMER WAS DIAGNOSED WITH A CORNEAL ABRASION IN THE RIGHT EYE AND WAS PRESCRIBED ANTIBIOTIC EYE DROPS OF UNKNOWN TYPE, FREQUENCY, AND DURATION. THE CURRENT CONDITION OF CONSUMER EYE WAS UNKNOWN AT THE TIME OF THIS REPORT. ADDITIONAL INFORMATION ON MEDICAL RECORDS AND SYMPTOM RESOLUTION HAS BEEN REQUESTED BUT NOT YET RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    468994 DAILIES COLORS LENSES, SOFT CONTACT, DAILY WEAR LPL CIBA VISION GMBH NA N0715910 00730822251136

    Patients

    Seq Age Sex Outcome Treatment
    1