Description of Event or Problem · 1
A PT CONTACTED OUR (B)(4) AFFILIATE ON (B)(6)2010 TO REPORT AN ADVERSE EVENT. THE PT COMPLAINED OF PAIN, REDNESS AND TEARING OD. THE PT HAD FOREIGN BODY SENSATION 2 DAYS AFTER STARTING TO WEAR 1-DAY TRUEYE LENSES. THE PT WAS DIAGNOSED WITH A CORNEAL ULCER OD. ON (B)(6)2010 THE PT WAS EXAMINED AN ECP AT AN EYE CLINIC AND WAS DIAGNOSED WITH CORNEAL ULCER AND PUNCTATE CORNEAL STAINING. THE ULCER WAS ELLIPTICAL AND LOCATED TEMPORAL, RIGHT SUPERIOR PART OF THE OD CORNEA, AROUND 10 O'CLOCK. THE ULCER WAS DESCRIED AS A WHITE DOT, 0.3MM IN DIAMETER WITH A SURROUNDING INFILTRATE "IN ONE-FOURTH OF THE SUPERFICIAL LAYER." THE ECP NOTED VERY TINY CORNEAL KERATIC PRECIPITATES (KPS), BUT NO CELLS WERE FOUND IN THE ANTERIOR CHAMBER. THE PT HAD "SEVERE CILIARY INJECTION" AND CORNEAL INFILTRATE. THE PT'S VA WAS 1.5 (20/13, WHICH WAS NOT AFFECTED. THE PT WAS TREATED WITH VIGAMOX, BESTRON, SANTEMYCIN AND HYALEIN EYE DROPS; TARIVID EYE OINTMENT; LOXONIN AND SELBEX TABLETS FOR 4 DAYS. ON (B)(6)2010, THE PT RETURNED TO THE EYE CLINIC AND THE ECP NOTED THAT THE PAIN RESOLVED, THE REDNESS IMPROVED AND KPS WERE OBSERVED. ON (B)(6)2010, THE PT RETURNED TO THE EYE CLINIC AND THE ECP NOTED THE REDNESS RESOLVED AND NO KPS WERE OBSERVED. THE PT'S CORNEA HAS VERY LITTLE FLUORESCEIN STAINING. ON (B)(6)2010, THE PT RETURNED TO THE EYE CLINIC AND THE ECP NOTED THAT THE ULCER RESOLVED. ON (B)(6)2010, THE PT RETURNED TO EYE CLINIC AND THE ECP NOTED THAT THE PT RECOVERED FROM ULCER. THE PT WAS ALLOWED TO RESUME CL WEAR. THE PARAMETERS OF 10 LENSES WERE MEASURED AND A VISUAL INSPECTION WAS PERFORMED. THE LENSES MET COMPANY STANDARDS FOR BASE CURVE, CENTER THICKNESS, AND DIAMETER. NO VISUAL ATTRIBUTES WERE OBSERVED. THE SOLUTION WAS ALSO TESTED. THE PH AND CONDUCTIVITY WERE IN SPECIFICATION. A REVIEW OF THE LOT HISTORY REVIEW WILL BE SUBMITTED IN A F/U REPORT. THIS IS BEING REPORTED AS A WORSE CASE DUE TO THE OBSERVATION OF KPS AND FREQUENCY OF F/U VISITS. IF ADD'L INFO IS RECEIVED, WILL REPORT WITHIN 30 DAYS OF RECEIPT. MDR REPORTABLE EVENT TRENDS ARE REVIEWED QUARTERLY IN EXECUTIVE MANAGEMENT REVIEW MEETINGS.