BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AIR OPTIX AQUA

    MDR report key: 13548773 · Received February 17, 2022

    Report

    Report Number
    3006186389-2022-00003
    Event Type
    Injury
    Date Received
    February 17, 2022
    Date of Event
    May 1, 2020
    Report Date
    July 18, 2022
    Manufacturer
    CIBA VISION JOHOR SDN, BHD.
    Product Code
    LPL
    PMA / PMN Number
    K073459
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    003

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

    Additional Manufacturer Narrative · 0

    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).

    Additional Manufacturer Narrative · 0

    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 ABNORMALITY OF INTERNAL PERIODIC TRENDING DURING THIS INVESTIGATION REVIEW. NO PRODUCT RETURN FOR EVALUATION THEREFORE NO ROOT CAUSE IDENTIFIED FOR THIS INVESTIGATION. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 0

    A CONSUMER REPORTED EXPERIENCING AN INFECTION, EYE PAIN, TEARING AND VISION LOSS AFTER WEARING A CONTACT LENS IN THE RIGHT EYE. THE CONSUMER REPORTED HISTORY OF CONTACT LENSES WEAR FOR OVER 20 YEARS AND HAS USED DIFFERENT BRAND. THE CONSUMER INFORMED FOLLOWING HAND HYGIENE AND DISINFECTANT SOLUTION. THE CONSUMER SOUGHT TREATMENT WITH MEDICAL DOCTOR, AND WAS TREATED WITH ¿INJECTIONS INTO CORNEA, EYE DROPS, AND ANTIBIOTICS, FURTHER EYE DROPS FOR PUPIL DILATION, STEROIDS, AND ANTI-INFLAMMATORIES.¿ ADDITIONALLY, TOOK ORAL MEDICATION TO ALLEVIATE EYE PAIN. ADDITIONAL INFORMATION WAS REQUESTED FOR THIS EVENT. UPON FOLLOW UP THE CONSUMER INFORMED OF A CORNEAL ULCER / ENDOPHTHALMITIS PER LABORATORY GUIDE THAT INCLUDED COLLECTION OF CORNEAL SECRETION. THE CONSUMER INFORMED HAVING AN ULTRASOUND OF THE EYE THAT SHOWED ¿PHAKIC, DIAMETER 25.7 MM REGULAR MACULAR AREA, EVIDENT PAPILLARY EXCAVATION, HIGH MOBILITY AND LOW REFLECTIVITY MEMBRANOUS ECHOES SUGGESTIVE OF POSTERIOR TOTAL VITREOUS DETACHMENT, CONDENSED POINT ECHOES OF LOW REFLECTIVITY AND HIGH MOBILITY SUGGESTIVE OF AN INFLAMMATORY/HEMORRHAGIC PROCESS.¿ EYE OINTMENT WAS PRESCRIBED AND WAS REGISTERED BY A DOCTOR A FOR A CORNEA TRANSPLANT. THE CONSUMER¿S CONDITION IS ONGOING AT THE TIME OF THE REPORT. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED AT THE TIME OF THIS REPORT. THIS THE FIRST PRODUCT EVENT FOR THIS REPORT.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED WHICH STATES THAT THE CONSUMER EXPERIENCED CORNEAL SCAR AND WANTED A SPECIAL LENS TO COVER THE SCAR. ADDITIONALLY, THE CONSUMER WILL HAVE THREE CORNEAL EXAMINATIONS. THE CONSUMER WAS TREATED WITH A COMBINATION OF DORZOLAMIDE AND TIMOLOL, TRAVOPROST, CARBOXYMETHYLCELLULOSE AND DEXPANTHENOL. IT WAS ALSO REPORTED THAT CONSUMER WORE COLORED LENSES FROM ANOTHER BRAND; HOWEVER, IT DID NOT RESOLVE THE PROBLEM, WITH ADDITIONAL INFORMATION; A SERIOUS EVENT, CANNOT BE RULED OUT AT THIS TIME OF REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    999020 AIR OPTIX AQUA LENSES, SOFT CONTACT, DAILY WEAR LPL CIBA VISION JOHOR SDN, BHD. NA 10383985

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention| S OPTI-FREE SOLUTION UNSPECIFIED.