BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVAIRA TORIC (ENFILCON A)

    MDR report key: 2200818 · Received August 8, 2011

    Report

    Report Number
    2640128-2011-00006
    Event Type
    Injury
    Date Received
    August 8, 2011
    Date of Event
    June 1, 2011
    Report Date
    July 11, 2011
    Manufacturer
    COOPER VISION CARRIBBEAN CORP.
    Product Code
    LPL
    PMA / PMN Number
    K071736
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT WAS REPORTED BY EYE CARE PRACTITIONER DIRECTLY TO COOPERVISION (B)(4). METHOD: A DEVICE FROM THE SAME LOT OF THE ACTUAL DEVICE INVOLVED IN THE INCIDENT WAS EVALUATED. THE DEVICE WAS EXAMINED FOR VISUAL DEFECTS AND MEASURED FOR PARAMETERS. RESULTS: THERE IS NO DIRECT CAUSAL RELATIONSHIP ESTABLISHED BETWEEN THE MEDICAL DEVICE AND THE INCIDENT THE PATIENT COMPLAINS OF. CONCLUSIONS: NO FAILURE WAS DETECTED AND THE PRODUCT WAS WITHIN SPECIFICATION. NO CONCLUSION CAN BE DRAWN. THIS IS BEING REPORTED AS CONFLUENT KERATITIS WITH NO DIRECT CAUSAL RELATIONSHIP ESTABLISHED BETWEEN THE MEDICAL DEVICE AND THE INCIDENT. SHOULD FURTHER INFORMATION BE PROVIDED THAT WOULD CHANGE THIS CONCLUSION, AN UPDATE TO THIS REPORT WILL BE PROVIDED WITHIN ONE MONTH OF RECEIPT OF THE ADDITIONAL INFORMATION.

    Description of Event or Problem · 1

    PATIENT INSERTED AVAIRA TORIC (ENFILCON A) LENS IN LEFT EYE AN FELT PAIN UPON INSERTION. PATIENT REMOVED THE LENS AND LET THE EYE CALM DOWN FOR 1-2 DAYS. PATIENT CLEANED AND DISINFECTED THE LENS AND REINSERTED WITHOUT PROBLEMS AND USED THE LENS FOR TWO WEEKS. ON JULY ELEVENTH, PATIENT INSERTED NEW LENS WITH REPEAT PAIN UPON INSERTION. LENS WAS IMMEDIATELY REMOVED. BY MIDNIGHT, THERE WAS INCREASED PAIN AND PATIENT VISITED THE HOSPITAL. DOCTORS REPORT MENTIONED LARGE AREA OF CONFLUENT KERATITIS. PATIENT WAS GIVEN CHLORAMPHENICOL AND THE EYE WAS PATCHED. ON (B)(6), THIRTEENTH PATIENT WAS SEEN FOR A FOLLOW UP AND REFERRED TO AN OPHTHALMOLOGIST THE NEXT DAY. OPHTHALMOLOGIST STATED THE CORNEA WAS IMPROVING AND PRESCRIBED LUBRICANTS ONLY WITH OINTMENT IF NEEDED. ON (B)(6), FOURTH, PATIENT'S EYE IS BACK TO NORMAL BUT VISION IS STILL SLIGHTLY REDUCED. PATIENT HAS BEEN ADVISED NOT TO WEAR LENSES FOR 2 - 3 WEEKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AVAIRA TORIC (ENFILCON A) LPL, SOFT CONTACT LENS, DAILY WEAR LPL COOPER VISION CARRIBBEAN CORP. 5618500436200415

    Patients

    Seq Age Sex Outcome Treatment
    1 Other