Description of Event or Problem · 1
A PATIENT WHO WAS WEARING ACUVUE2 CONTACT LENSES WAS SWITCHED TO ACUVUE ADVANCE CONTACT LENSES. THE PT WORE THE LENSES ON A 30 DAY, DAILY WEAR SCHEDULE. THE EYE CARE PROFESSIONAL (ECP) REPORTED THAT ON THE 15TH DAY OF USE, THE PATIENT REPORTED DISCOMFORT AND REMOVED AND CLEANED THE LENS WITH "SALT SOLUTION" AND WOR THE LENSES FOR 5 MORE DAYS. AT THE 20TH DAY OF WEAR, THE LENSES WERE IRRITATING AND THE PATIENT REPORTEDLY REMOVED THAT PAIR AND INSERTED A NEW PAIR OF LENSES. THE PT SAW THE ECP IN 2006 AND WAS DIAGNOSED WITH A CENTRAL CORNEAL ULCER. THE PATIENT WASW TREATED WITH ZYMAR DROPS. TWO DAYS LATER, THE PT RETURNED TO THE DOCTOR'S OFFICE AND WAS REPORTED TO BE BETTER WITH NO VISUAL IMPAIRMENT. THE PATIENT RETURNED TO THE ECP'S OFFICE SIX DAYS LATER, AND THE PATIENT STOPPED MEDICATIONS AT THAT TIME. THERE WAS NO LOSS OF VISUAL ACUITY. THE DOCTOR INDICATED THAT CORNEAL ULCER WAS NOT DUE TO THE SPECIFIC CONTACT LENS, BUT DUE TO THE CONTACT LENS WEARING HABITS OF THE PATIENT AND THE PATIENT DID NOT FOLLOW THE CORRECT LENS REPLACEMENT SCHEDULE. NIE DAYS LATER, RECEIVED INFORMATION FROM OUR AFFILIATE. THE ECP SAID THIS WAS A SERIOUS CORNEAL ULCER AND THE PT WAS STILL RECEIVING MEDICAL TREATMENT. THE PATIENT WAS CONTACTED AND WE LEARNED THAT THE PT STOPPED TAKING THE PRESCRIBED MEDICATION AND THE PATIENT HAD RESUMED WEARING ACUVUE 2 CONTACT LENSES. THE PATIENT WAS ADVISED TO NOT WEAR CONTACT LENSES WITHOUT THE ECP'S APPROVAL. THE PATIENT WAS ALSO CAUTIONED TO FOLLOW THE PRESCRIBED WEAR SCHEDULE AND CONTACT LENS MAINTENANCE INSTRUCTIONS. THE LENSES IN QUESTION WERE REQUESTED FOR EVALUATION BUT HAVE NOT BEEN RECEIVED. LOT HISTORY REVIEW: THE BATCH RECORD DID NOT SHOW ANY ABNORMALITIES IN MONOMER AND SOLUTION TESTING. ALL PARAMETERS TESTED WERE WITHIN SPECIFICATION. ALL STERILIZATION REQUIREMENTS WERE SUCCESSFULLY COMPLETED.