Description of Event or Problem · 0
HELLO FDA CONSUMER COMPLAINT COORDINATOR, THIS IS A FOLLOW UP TO A CALL EARLIER IN THE DAY ABOUT A (B)(6) RESIDENT THAT WENT BLIND FROM ACANTHAMOEBA KERATITIS. OUR GOAL IN REACHING OUT IS TO ENSURE THIS IS DOCUMENTED WITH THE FDA, BUT WE WOULD ALSO APPRECIATE INFORMATION ON WHAT IS BEING DONE TO PREVENT THIS FROM HAPPENING TO PATIENTS IN THE FUTURE. THE PATIENT HAS SAID YOU ARE WELCOME TO CONTACT HIM ( (B)(6)). HE IS HAS BEEN SEEING DR. (B)(6) WITH EYE ASSOCIATES OF (B)(6) IN ADDITION TO OTHERS. BACKGROUND: (B)(6) CONTRACTED AN ACANTHAMOEBA INFECTION IN HIS EYE IN THE SPRING OF 2021 WHILE USING TAP WATER (FROM (B)(6)) ON HIS CONTACT LENSES AND WENT BLIND IN BOTH EYES SHORTLY AFTER. HE HAS SENSE UNDERGONE A CORNEA TRANSPLANT. THIS INFECTION SEEMS ASSOCIATED WITH SCLERAL CONTACT LENSES WHICH REQUIRE THE USER TO PLACE FLUID UNDER THE LENS AS OPPOSED TO THE TRADITIONAL LENSES WHICH DO NOT REQUIRE FLUID UNDER THE LENS. THESE LENSES MAY ALSO CAUSE ABRASION ON THE EYE WHICH ENHANCES THE CHANCES OF AN AMOEBA INFECTION. ACCORDING TO (B)(6), CEO OF (B)(6) WHICH MAKES THE AMOEBA TREATING DRUG, THIS HAPPENS TO ~2000 TO 5000 PER YEAR, 90% OF THOSE ARE CONTACT LENSE WEARERS, MOST OF WHICH GO BLIND. ADDITIONALLY 1 TO 2% NEED TO HAVE THEIR EYE COMPLETELY REMOVED. ACANTHAMOEBA INFECTIONS MAY BE GETTING MORE PREVALENT DUE TO CLIMATE CHANGE, GIVEN THE AMOEBA PREFERS WARM WATER. SO FAR THE WATER TREATMENT MANAGER AT (B)(6) HAS BEEN NOTIFIED ((B)(6)). COULD YOU LET US KNOW WHAT THE CURRENT RULES ARE IN TERMS OF WARNINGS AND LABELING FOR THESE CONTACT LENSES?.