Description of Event or Problem · 1
OUR (B)(4) AFFILIATE REPORTS A PT REPORTED PAIN, FOREIGN BODY SENSATION, REDNESS AND CLOUDY VISION OU WHILE WEARING 1-DAY ACUVUE TRUEYE (NARAFILCON A) TRIAL CONTACT LENSES FOR 10 DAYS, IN LATE 7/2010. NARAFILCON A LENSES ARE NOT MARKETED IN THE U.S. THE PT REPORTED THAT HE/SHE DEVELOPED CORNEAL ULCERS AND CORNEAL ABRASIONS OU. THE PT SAID HE/SHE SOUGHT TREATMENT FROM AN EYE CARE PROFESSIONAL. THE PT INITIALLY WOULD NOT ALLOW OUR AFFILIATE TO CONTACT THE TREATING ECP FOR ADD'L INFO. ON (B)(6)2010, THE PT WAS CONTACTED FOR F/U INFO, AND TOLD US THAT THE CORNEAL EPITHELIUM HAD REGENERATED AND HE/SHE WAS ALLOWED TO RESUME CL WEAR. THE PT ALLOWED US TO CONTACT THE TREATING ECP. THE CLINIC WAS CONTACTED ON (B)(6)2010 AND PROVIDED THE FOLLOWING INFO. THE PT WAS INITIALLY SEEN ON (B)(6)2010 AND WAS DIAGNOSED WITH A CORNEAL ULCER OS. THE CORNEAL ULCER WAS LOCATED IN THE SUPERIOR, TEMPORAL CORNEA AT ONE THIRTY, AND AWAY FROM THE CENTRAL CORNEA. THE SIZE WAS ABOUT 2 MM X 2 MM. THE PT WAS TREATED WITH BESTRON, VIGAMOX, BRONUCK EYE DROPS AND TARIVID OINTMENT AND D/C CL WEAR. THE "SYMPTOM WAS PERSISTENT AND CORNEAL CURETTAGE WAS PERFORMED ON (B)(6)2010." THE PT WAS ALLOWED TO RESUME CL WEAR ON (B)(6)2010. THE ECP DID NOT KNOW IF THIS EVENT WAS RELATED TO CL WEAR. NO ADD'L INFO IS AVAILABLE AT THIS TIME. "CORNEAL ULCER" MAY OR MAY NOT BE A SERIOUS INJURY IN ACCORDANCE WITH THE SERIOUS INJURY DETERMINATION FORM. BASED ON THE LIMITED INFO RECEIVED, THIS INJURY WILL BE REPORTED AS A SERIOUS INJURY AS A WORST CASE. THE PRODUCT IN QUESTION IS NOT AVAILABLE. A LOT HISTORY REVIEW WAS REQUESTED FOR THE LOT IN QUESTION AND WILL BE SENT IN A F/U REPORT. THERE HAVE BEEN NO SIMILAR REPORTS ASSOCIATED WITH THIS LOT NUMBER. AS A CORNEAL ULCER MAY OR MAY NOT BE A SERIOUS INJURY AND DETAILS OF LOCATION, SIZE, VISUAL ACUITY OR CONFIRMATION BY A MEDICAL PROFESSIONAL WERE NOT AVAILABLE, THIS EVENT IS BEING REPORTED AS WORST CASE.