BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVAIRA VITALITY (FANFILCON A)

    MDR report key: 10812102 · Received November 9, 2020

    Report

    Report Number
    2640128-2020-00010
    Event Type
    Injury
    Date Received
    November 9, 2020
    Date of Event
    August 15, 2020
    Report Date
    April 23, 2021
    Manufacturer
    COOPERVISION MANUFACTURING PUERTO RICO, LLC
    Product Code
    LPL
    PMA / PMN Number
    K160803
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H3: NO DEVICE SAMPLE RETURNED FOR MANUFACTURER ANALYSIS AND NO LOT NUMBER REPORTED, NO INVESTIGATION COULD BE COMPLETED, AND NO ROOT CAUSE ESTABLISHED. THE RELATIONSHIP BETWEEN THE COOPERVISION DEVICE AND THE INCIDENT IS UNCONFIRMED. CONFIRMED THAT THE SAMPLES WERE SENT FOR ANALYSIS FIRST AT (B)(6) HOSPITAL THEN TO A TEST LAB IN LONDON, CONTACT LENSES AND PACKAGING HAVE BEEN DESTROYED.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED FROM LIVERPOOL UNIVERSITY HOSPITAL WHERE THE PATIENT WAS REFERRED FOR FURTHER CARE. THE PATIENT PRESENTED 18 AUGUST ON REFERRAL FROM WREXHAM HOSPITAL WITH EYE PAIN AND CORNEAL ULCER OF THE LEFT (OS) EYE. EXAMINATION SHOWED SUBEPITHELIAL STROMAL INFILTRATES OF THE RIGHT EYE, AND 1.4MM HYPOPYON, 5MM V, 8MM H CORNEAL EPITHELIAL DEFECT, CORNEAL THINNING, STROMAL INFILTRATES, A CENTRAL ROUND INFILTRATE IN THE LEFT EYE, DIAGNOSED WITH MICROBIAL KERATITIS AND SCLERITIS. THE PATIENT WAS SEEN ON (B)(6) WITH NO CHANGE, (B)(6) HYPOPYON WAS RESOLVED AND INFILTRATE ALMOST RESOLVED, EPITHELIAL DEFECT DECREASED IN SIZE, MEDICATIONS REDUCED. (B)(6) CONFIRMED PSEUDOMONAS, EPITHELIAL DEFECT CONTINUES TO DECREASE IN SIZE, INFILTRATE ALMOST RESOLVED, HYPOPYON RESOLVED. (B)(6), KERATITIS IS HEALING, DEFECT CONTINUES TO DECREASE IN SIZE, INFILTRATE RESOLVED. (B)(6), INCIDENT IS MUCH IMPROVED, EPITHELIAL DEFECT IS RESOLVED, PATIENT TO FOLLOW-UP IN SIX WEEKS. (B)(6), KERATITIS HAS RESOLVED BUT RESULTED IN SCARING AFFECTING VISION. PATIENT TO FOLLOW-UP FOR POSSIBLE CONTACT LENS FITTING OR CONSIDER DALK/PK IF NO IMPROVEMENT.

    Additional Manufacturer Narrative · 1

    NO DEVICE SAMPLE RETURNED FOR MANUFACTURER ANALYSIS AND NO LOT NUMBER REPORTED, NO INVESTIGATION COULD BE COMPLETED, AND NO ROOT CAUSE ESTABLISHED. THE RELATIONSHIP BETWEEN THE COOPERVISION DEVICE AND THE INCIDENT IS UNCONFIRMED.

    Description of Event or Problem · 1

    THE PATIENT REPORTS THAT THEY EXPERIENCED PAIN, SORENESS, IRRITATION AND REDNESS OF BOTH EYES, WHICH INCREASED THROUGHOUT THE DAY, AND SOUTH MEDICAL ATTENTION AT (B)(6) HOSPITAL ACCIDENT AND EMERGENCY. THE PATIENT WAS GIVEN CHLORAMPHENICOL AND ANTIBIOTIC OINTMENT AND INSTRUCTED THE RETURN THE NEXT DAY. THE PATIENT REPORTS THEY WERE INFORMED THERE WAS AN ABRASION OF THE LEFT (OS) EYE CAUSING A SEVERE INFECTION, THE RIGHT (OD) EYE WAS ALSO INFECTED. THE PATIENT WAS ALSO EXPERIENCING DECREASED VISION IN BOTH EYES. THE FOLLOWING DAY THE PATIENT WAS PRESCRIBED OFLOXACIN, BROLENE, AND CYCLOPENTOLATE. TWO DAYS FOLLOWING THE INCIDENT, THE PATIENT WAS REFERRED TO (B)(6) EYE DEPARTMENT AT (B)(6) HOSPITAL WHERE THEY CONFIRMED LEFT EYE ABRASION AND INFECTION AND MINOR INFECTION OF THE RIGHT EYE. THE PATIENT STATES THAT THE CONTACT LENSES INVOLVED IN THE INCIDENT WERE SENT TO A LAB IN (B)(6) FOR TESTING AS WELL AS CULTURES FROM THE EYES WHICH REVEALED KERATITIS (UNSPECIFIED). THE PATIENT HAS REQUIRED MANY FOLLOW-UP VISITS AND MEDICATIONS INCLUDING CILOXAN, CHLORAMPHENICOL, INDOMETHACIN, CO-CODAMOL, POLYHEXAMETHYLENE BIGUANIDE, AND PREDNISOLONE ACETATE. AT THE TIME OF THIS REPORT THE PATIENT REMAINS UNDER CARE AND IS ON A FOUR WEEK STEROID CYCLE AFTER WHICH THEY WILL RETURN TO CARE. THE PATIENT HAS REGAINED FULL SIGHT IN THE RIGHT EYE BUT THE LEFT EYE REMAINS UNRESOLVED AND MAY REQUIRE SURGICAL INTERVENTION. GOOD FAITH EFFORTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFO WITHOUT SUCCESS, ADDITIONAL INFO IS UNKNOWN. THIS EVENT IS BEING REPORTED IN AN ABUNDANCE OF CAUTION DUE TO LACK OF MEDICAL INFO, INCOMPLETE DIAGNOSIS, AND UNKNOWN RESOLUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1278641 AVAIRA VITALITY (FANFILCON A) AVAIRA VITALITY (FANFILCON A) LPL COOPERVISION MANUFACTURING PUERTO RICO, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R