BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAILIES TOTAL 1 MULTIFOCAL

    MDR report key: 14651338 · Received June 9, 2022

    Report

    Report Number
    9610813-2022-00010
    Event Type
    Injury
    Date Received
    June 9, 2022
    Date of Event
    May 14, 2022
    Report Date
    July 11, 2022
    Manufacturer
    CIBA VISION GMBH
    Product Code
    LPL
    PMA / PMN Number
    K113168
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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 SECOND 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 THE FIRST REPORT FILED UNDER THE QS#(B)(4). FOR THE REPORTED LOT NUMBER N1195825. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    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. NO COMPLAINT OR MANUFACTURING TREND WAS IDENTIFIED. THE ROOT CAUSE COULD NOT BE DETERMINED. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 0

    AN OPTICIAN REPORTED ON BEHALF OF THE CONSUMER THAT THE CONTACT LENS WAS TOO ATTACHED TO THE CORNEA, AND IT WAS IMPOSSIBLE TO REMOVE IT. CONSUMER CONSULTED OPTICIAN, INDEED, OPTICIAN ALSO FOUND MANY DIFFICULTIES IN REMOVING IT, BUT WITH THE AID OF AN EYE CUP, AND PHYSIOLOGICAL SOLUTION, THEY MANAGED TO DO IT. CONSUMER UNDERWENT A FLUORESCEIN SLIT LAMP EXAMINATION WHICH SHOWED MARKED CORNEAL SUFFERING AT THE APICAL LEVEL AND A REAL CORNEL ULCER. IT WAS ALSO REPORTED THAT THERE WERE NO DEPOSITS, NOR ALTERATIONS OF THE EDGE NOTICED AFTER EXAMINING THE SURFACE OF THE LENS WITH THE LAMP AND WITH THE MAGNIFICATIONS. OPTICIAN SUGGESTED A CONSUMER CONTACT, A TRUSTED OPHTHALMOLOGIST, BUT THE SAME CUSTOMER PREFERRED TO USE TOBRAMYCIN DEXAMETHASONE AND CLOSE THE EYE FOR 24 HOURS WITH STERILE GAUZE. THE CURRENT STATUS OF THE EYE WAS UNKNOWN AT THE TIME OF REPORTING. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    599634 DAILIES TOTAL 1 MULTIFOCAL LENSES, SOFT CONTACT, DAILY WEAR LPL CIBA VISION GMBH NA N1196717

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention