BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAILIES TOTAL 1 MULTIFOCAL

    MDR report key: 20863935 · Received December 6, 2024

    Report

    Report Number
    9610813-2024-00065
    Event Type
    Injury
    Date Received
    December 6, 2024
    Date of Event
    October 12, 2024
    Report Date
    March 27, 2025
    Manufacturer
    CIBA VISION GMBH
    Product Code
    LPL
    UDI-DI
    00846566847396
    PMA / PMN Number
    K113168
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    B.5., FIELD UPDATED. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4). H.11 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 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. D.4.: THIS IS THE FIRST OF TWO REPORTS FOR THE SAME PATIENT INVOLVING TWO LOT NUMBERS OF THE SAME PRODUCT. IT IS UNKNOWN WHICH CONTRIBUTED TO THE EVENT. REFER TO QS#(B)(4) FOR THE REPORTED LOT NUMBER N1282951. 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. 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

    UPON FURTHER REVIEW OF THE FILE, IT WAS ASSESSED THAT THE INFORMATION REGARDING THE EVENT HYPOPYON IS NOT CLEAR IN THE MEDICAL RECORD, MOREOVER IT WAS STATED INITIALLY THAT THERE WAS NO HYPOPYON SEEN DURING THE INITIAL LAB DIAGNOSIS. STILL THE FILE IS CONSIDERED TO BE SERIOUS AND REPORTABLE.

    Description of Event or Problem · 0

    AS INITIALLY REPORTED THE CONSUMER EXPERIENCED OCULAR PAIN IN RIGHT EYE FOR TWO DAYS AFTER WEARING CONTACT LENS. CONSUMER VISITED DOCTOR AND PROVIDED EMERGENCY ROOM REPORT IN WHICH SHE WAS DIAGNOSED WITH CONJUNCTIVAL CHEMOSIS, CENTRAL CORNEAL ABSCESS OF ABOUT 4 MILLI METER IN DIAMETER IN RIGHT EYE. CONSUMER WAS ADVISED TO ABSTAIN FROM CONTACT LENSES AND CORNEAL SCRAPING PERFORMED FOR GRAM POSITIVE SEARCH. NEGATIVE AEROBES ANAEROBIC AND FUNGI. CONSUMER WAS PRESCRIBED WITH GLYCOPEPTIDE ANTIBIOTIC ONE DROPS EVERY HOUR, TOBRAMYCIN ONE DROP FOR EVERY HOUR, POLY HEXAMETHYLENE ONE DROP FOR SIX TIMES A DAY AND CYCLOPENTOLATE ONE DROP FOR EVERY MORNING AND EVENING. PAINKILLER IF NEEDED. DOCTOR ADVISED TO REVISIT. ON NEXT VISIT CONSUMER HAD DECREASED IN CORNEAL ABSCESS AND HYPOPYON WITH ANTERIOR CHAMBER WAS QUIET AND NORMAL DEEP AND PRESCRIBED WITH TOBRAMYCIN ONE DROP, CYCLOPENTOLATE ONE DROP ONCE A DAY, FLUOROQUINOLONES ONE DROP FOR FOUR TIMES A DAY. SWAB ON RIGHT CORNEAL SCRAPING WAS DONE. DEVELOPMENT OF PSEUDOMONAS AERUGINOSA WAS PERFORMED. THE CURRENT STATUS OF CONSUMER¿S EYE WAS NOT KNOWN AT THE TIME OF THE REPORT. ADDITIONAL INFORMATION ON EYE SOLUTION HAS BEEN REQUESTED BUT NOT YET RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2487462 DAILIES TOTAL 1 MULTIFOCAL LENSES, SOFT CONTACT, DAILY WEAR LPL CIBA VISION GMBH NA N1282391 00846566847396

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Female Required Intervention| O