Description of Event or Problem · 1
PATIENT WAS TREATED WITH PKS FOR SEVERE KERATITIS WHICH INCLUDED SPK AND INFLAMMATION; NO EPITHELIAL DEFECT OBSERVED BEFORE TREATMENT. PKS WAS IMPLANTED ON 10/01 WITHOUT INCIDENT. PATIENT CALLED THE OFFICE ON 10/03 AND REPORTED EXPERIENCING DISCOMFORT. THE DEVICE WAS REMOVED ON 10/05. THE PHYSICIAN DID NOT OBSERVE ANY EPITHELIAL DEFECT OR EVIDENCE OF INFILTRATE, SUGGESTIVE OF INFECTION. THREE DAYS LATER, THE PATIENT PROVIDED THE PHYSICIAN WITH A PICTURE OF THEIR EYE SUGGESTIVE OF AN INFECTION AND AN 8MM EPITHELIAL DEFECT AND AN ELEVATED DENSE INFILTRATION. PHYSICIAN SENT PATIENT TO KELLOGG EYE INSTITUTE FOR WORK UP AND TREATMENT. ON 10/15 THE TREATING PHYSICIAN CONTACTED THE PATIENT TO FOLLOW UP AND STATED THE FOLLOWING, "PER CONFOCAL MICROSCOPY ON 10-9 PROBABLE DIAGNOSIS WAS ACANTHAMOEBA KERATITIS OS. THIS WAS CONFIRMED BY CORNEAL CULTURE TAKEN THE SAME DAY. PATIENT IS CURRENTLY BEING FOLLOWED BY UM AND IS ON MAXIMUM THERAPY. PT HAS A HISTORY OF KERATOCONUS AND WEARS SCLERAL CONTACT LENSES. THE LAST TIME SHE WORE A LENS IN OS WAS LATE AUGUST DUE TO DISCOMFORT." TTI MEDICAL DIRECTOR REVIEWED THE FOLLOW-UP INFORMATION AND INDICATED THAT DUE TO THE ORGANISM IDENTIFIED, THE CAUSE OF THE INFECTION WOULD NOT BE RELATED TO THE PROKERA AS THIS MICROBE IS KNOWN TO COME FROM OTHER SOURCES, E.G., CONTAMINATED WATER, SOLUTION, ESPECIALLY CONTACT LENSES. FINAL PRODUCT MICROBIAL TESTING FOR PKS LOT BTR191696 CONFIRMED THERE WAS NO GROWTH PRESENT. ADDITIONALLY, ENVIRONMENTAL MONITORING DATA INDICATES THIS ORGANISM HAS NEVER BEEN IDENTIFIED IN A SAMPLE AT TTI.