BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENFILCON A / AVAIRA SPHERE

    MDR report key: 3873150 · Received June 13, 2014

    Report

    Report Number
    2640128-2014-00007
    Event Type
    Injury
    Date Received
    June 13, 2014
    Date of Event
    May 9, 2014
    Report Date
    May 20, 2014
    Manufacturer
    COOPERVISION CARIBBEAN CORPORATION
    Product Code
    LPL
    PMA / PMN Number
    K071736
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UNOPENED LENSES WITH SAME LOT RETURNED AND ONE WAS INSPECTED. ACTUAL LENS (SUSPECT) NOT RETURNED. NO DEFECT FOUND. THE COMPLAINT IS UNCONFIRMED. THE ASSOCIATION BETWEEN COOPERVISION LENSES AND THE INCIDENT IS UNCONFIRMED. SUBMISSION OF THIS REPORT DOES NOT, IN ITSELF, REPRESENT A CONCLUSION BY THE MANUFACTURER AND/OR AUTHORIZED REPRESENTATIVE THAT MEDICAL PERSONNEL CAUSED OR CONTRIBUTED TO THE EVENT AND/OR THE MEDICAL DEVICE(S) LISTED FAILED IN ANY MANNER AND/OR THAT THE MEDICAL DEVICE(S) CAUSED OR CONTRIBUTED TO THE ALLEGED EVENT.

    Description of Event or Problem · 1

    INITIAL REPORT FROM A VISION CENTER RELATES THAT A PATIENT CAME TO THE CENTER ON (B)(6) 2014 WITH A CLAIM OF A CONTAMINATED BOX OF CONTACTS, HAD VERY RED AND SWOLLEN EYES AND HAD BEEN SEEN BY A MEDICAL DOCTOR. THE PATIENT RELATES A PREVIOUS EPISODE AFTER WHICH SHE WORE EYE GLASSES UNTIL RESOLVED. UPON INSERTING ANOTHER SET OF CONTACTS FROM THE SAME BOX, HAD IMMEDIATE INFLAMMATION AND REDNESS. THE VISION CENTER OPTOMETRIST EXAMINED HER EYES AND THINKS THIS BOX OF CONTACTS MAY BE CONTAMINATED. THE MEDICAL DOCTOR RESPONDED WITH FOLLOW UP INFORMATION BY PHONE. THE DOCTOR RELATED THE SAME PATIENT COMPLAINTS AS ON (B)(6) 2014 AS DESCRIBED ABOVE WITH THE ADDITION THAT THE PATIENT WAS PRESCRIBED TOBRAMYCIN. THE REDNESS THEN RESOLVED. THEN THE PATIENT PUT ONE OF THE OLD LENSES BACK INTO HER EYE, AND HER EYE WAS BRIGHT RED AGAIN. FOLLOW-UP COMMUNICATIONS MADE BY COOPERVISION WITH THE PATIENT AND THE DOCTOR FOR CLARIFICATION RELATED SIMILAR EVENT DESCRIPTIONS AS DESCRIBED ON (B)(6) 2014. HOWEVER, THE DOCTOR RELATES REOCCURRENCE OF THE REDNESS AFTER INSERTION OF THE OLD LENS AND THE PATIENT RELATES REOCCURRENCE AFTER INSERTION WITH A NEW LENS FROM A DIFFERENT BOX (DIFFERENT LOT). THE PATIENT ALSO RELATED THAT HER EYES BECAME INFECTED AND GOOPY AND THAT THE DOCTOR TOLD HER THAT HER CORNEA BROKE DOWN DUE TO THE LENSES. AN ACTUAL DIAGNOSIS IN THIS CASE CANNOT BE CONFIRMED WITHOUT ADDITIONAL FOLLOW UP. GOOD FAITH EFFORT HAS BEEN MADE TO OBTAIN THE ADDITIONAL INFORMATION BUT NO FURTHER INFORMATION HAS BEEN RECEIVED AS OF THIS REPORT. COOPERVISION IS REPORTING THIS EVENT ON THE REPORT OF INFECTION AND THE MEDICATION PRESCRIBED AS INTERVENTION. TWO UNOPENED LENSES WERE RETURNED. ONE LENS WAS INSPECTED WITH NOT DEFECT FOUND. THE COMPLAINT RESOLUTION IS UNCONFIRMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350705 ENFILCON A / AVAIRA SPHERE ENFILCON A / AVAIRA SPHERE LPL COOPERVISION CARIBBEAN CORPORATION 508255013908

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R