BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AIR OPTIX COLORS

    MDR report key: 10011414 · Received April 29, 2020

    Report

    Report Number
    3006186389-2020-00004
    Event Type
    Injury
    Date Received
    April 29, 2020
    Report Date
    May 19, 2020
    Manufacturer
    CIBA VISION JOHOR SDN, BHD.
    Product Code
    LPL
    PMA / PMN Number
    K133176
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    NO SAMPLE EVALUATION WAS PERFORMED AS SAMPLE WAS NOT RETURNED. THERE ARE NO OTHER SIMILAR COMPLAINTS REPORTED ON THIS LOT. INVESTIGATION HAS BEEN COMPLETED BASED ON CURRENT INFORMATION. RETAIN SAMPLE EVALUATION WAS PERFORMED AS PER CRITERIA; VISUAL MANTIS INSPECTION, VACUUM TESTER FOR LEAKAGE AND PACKAGING INSPECTION. THE RESULTS FOUND THAT THERE WAS NO ANY NON-CONFORMANCE AS REPORTED BY CUSTOMER IN THE 12 PIECES OF LENSES. FROM THE DHR FINISHING REVIEW, THERE IS NO ANY ABNORMALITIES OBSERVED DURING THE MANUFACTURING OF THIS COMPLAINT LOT. THE LOT MET THE RELEASE SPECIFICATION ACCORDING TO MANUFACTURING PROCEDURE. THE LOT HAS UNDERGONE THE STERILIZATION PROCESS PARAMETER AND BI INCUBATION RESULT ALSO MET SPECIFICATIONS. THERE IS NO NONCONFORMANCE REPORTED DURING THE MANUFACTURING OF THIS LOT. NO CONTRIBUTING FACTOR IDENTIFIED IN THE MANUFACTURING INVESTIGATION. NO PRODUCT RETURN FOR EVALUATION THEREFORE NO ROOT CAUSE IDENTIFIED FOR THIS INVESTIGATION. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 1

    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 2020-20218-01 FOR THE REPORTED LOT NUMBER 10370827. 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 · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED DISCOMFORT WHILE WEARING THE COMPLAINT CONTACT LENSES. SHE CONTINUED TO USE THE CONTACT LENSES EVEN THOUGH THEY WERE UNCOMFORTABLE. THE PATIENT VISITED AN EYE CARE PROFESSIONAL (ECP), WAS DIAGNOSED WITH CORNEAL ULCER AND WAS PRESCRIBED WITH UNKNOWN MEDICATIONS. IT WAS MENTIONED THAT THE LEFT EYE (OS) WAS HEALED WITH NO RESIDUAL EFFECTS BUT THE PATIENT HAD NOT RESUMED CONTACT LENS WEAR. ADDITIONAL INFORMATION WAS RECEIVED ON 13APR2020 VIA TELEPHONE CALL. IT WAS REPORTED THAT THE PATIENT HAD BEEN SLEEPING WITH THE CONTACT LENSES ON. ADDITIONAL INFORMATION WAS RECEIVED ON 16APR2020 VIA FAX FROM THE ECP. IT WAS REPORTED THAT THE PATIENT EXPERIENCED SEVERE PAIN OR DISCOMFORT, SEVERE REDNESS AND WATERY AND MUCOPURULENT DISCHARGE. IT WAS ADDED THAT THERE WERE TWO INFILTRATES, HOWEVER, THE LOCATION WAS UNKNOWN. THE PATIENT WAS TREATED WITH PREDNISOLONE DROPS THREE TIMES DAILY. IT WAS MENTIONED THAT THE EVENT HAD RESOLVED. ADDITIONAL INFORMATION RECEIVED ON 16APR2020 VIA EMAIL. THE ECP CONFIRMED THAT IT WAS A PERIPHERAL ULCER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    475569 AIR OPTIX COLORS LENSES, SOFT CONTACT, DAILY WEAR LPL CIBA VISION JOHOR SDN, BHD. NA 10452433

    Patients

    Seq Age Sex Outcome Treatment
    1 Other