BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAILIES TOTAL 1 MULTIFOCAL

    MDR report key: 20975249 · Received December 19, 2024

    Report

    Report Number
    9610813-2024-00067
    Event Type
    Injury
    Date Received
    December 19, 2024
    Date of Event
    September 12, 2024
    Report Date
    March 26, 2025
    Manufacturer
    CIBA VISION GMBH
    Product Code
    LPL
    PMA / PMN Number
    K113168
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION HAS BEEN RECEIVED AND UPDATED IN B5, B2 AND H6. 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.

    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. 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. 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. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION HAS BEEN PROVIDED INDICATING THAT THE CONSUMER WAS DIAGNOSED WITH SEVERE KERATITIS, AS DESCRIBED BY THE TREATING DOCTOR. THE DOCTOR ALSO NOTED THAT INFLAMMATION CAUSED BY THE CONTACT LENSES LED TO SIGNIFICANT DISCOMFORT AND PAIN, SEVERELY IMPACTING THE CONSUMER'S ABILITY TO CARRY OUT NORMAL DAILY ACTIVITIES. THE CONSUMER WAS PRESCRIBED WITH TOBRAMYCIN, THREE MG/G, OPHTHALMIC OINTMENT, (ONE APPLICATION EVERY TWENTY-FOUR HOURS FOR TEN DAYS), TOBRAMYCIN, THREE MG/G, EYE DROPS, DROPPER BOTTLE - FIVE ML (ONE DROP EVERY FOUR HOURS FOR TEN DAYS)/- MOXIFLOXACIN, 5 MG/ML, EYE DROPS, SOLUTION, DROPPER BOTTLE ¿ FIVE ML (ONE DROP EVERY FOUR HOURS FOR TEN DAYS). THE CURRENT STATUS OF THE CONSUMER'S EYE WAS CONTINUING AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    AS INITIALLY REPORTED BY THE HEALTH AUTHORITY STATING THAT THE CONSUMER EXPERIENCED CORNEAL ABSCESS. NO MEDICAL INTERVENTION HAS BEEN REPORTED. THE CURRENT STATUS OF THE CONSUMER'S EYE REMAINS UNKNOWN AT THE TIME OF THIS REPORT. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2099022 DAILIES TOTAL 1 MULTIFOCAL LENSES, SOFT CONTACT, DAILY WEAR LPL CIBA VISION GMBH NA N1263365

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Female Other| R