MYDAY (STENFILCON A)

Additional Manufacturer Narrative

DEVICE SAMPLE RETURNED AND ANALYZED. ALL DEVICE PARAMETERS WERE WITHIN EXPECTED VALUES. RECORD REVIEW FOUND NO ISSUES, NONCONFORMANCE'S, OR TRENDS. NO ROOT CAUSE CAN BE ESTABLISHED, THE RELATIONSHIP BETWEEN THE COOPERVISION DEVICE AND THE INCIDENT IS UNCONFIRMED. SHOULD FURTHER INFORMATION BECOME AVAILABLE, THE MANUFACTURER WILL COMPLETE FURTHER INVESTIGATIONS AS APPROPRIATE AND SUBMIT A FOLLOW-UP REPORT AS APPLICABLE.

Description of Event or Problem

THIS INCIDENT WAS REPORTED BY THE PATIENT, AND ONLY LIMITED CLINICAL INFORMATION IS AVAILABLE. FOLLOWING CONTACT LENS USE THE PATIENT DESCRIBES EXPERIENCING RECURRENT ALLERGIC REACTIONS, SYMPTOMS NOT DESCRIBED, THAT CONSEQUENTLY PROGRESSED TO AN UNSPECIFIED OCULAR INFECTION. THE PATIENT WAS TREATED WITH PREDNISONE OPHTHALMIC DROPS. IN FURTHER CORRESPONDENCE, THE HEALTHCARE PROVIDER STATED THAT WHILE THE PATIENT WAS TREATED FOR AN EYE INFECTION, IN THEIR ASSESSMENT, IT WAS NOT BELIEVED TO BE CAUSED BY THE LENSES, HOWEVER, NO FURTHER INFORMATION ON POSSIBLE CAUSES OR OTHER EVENT DETAILS HAVE BEEN PROVIDED. GOOD FAITH EFFORTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT AND TREATMENT WITHOUT SUCCESS. THIS EVENT IS BEING REPORTED IN AN ABUNDANCE OF CAUTION DUE TO THE UNKNOWN NATURE OR SEVERITY OF THE ALLEGED INFECTION WITH A LACK OF MEDICAL INFORMATION, AND THE POTENTIAL FOR SERIOUS OR PERMANENT INJURY, OR THE NECESSITY OF MEDICAL INTERVENTION OR MEDICATION TO PREVENT OR PRECLUDE THE OCCURRENCE OF SUCH EVENT, ASSOCIATED WITH SOME OCULAR INFECTIONS. SHOULD FURTHER INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED AS APPROPRIATE.