ACUVUE® OASYS® FOR ASTIGMATISM

Description of Event or Problem

ON (B)(6) 2026, MEDWATCH REPORT MW5188977 WAS RECEIVED FROM THE UNITED STATES FOOD AND DRUG ADMINISTRATION (FDA) IN WHICH A PATIENT (PT) IN ISRAEL REPORTED INSERTING A NEW PAIR OF ACUVUE® OASYS® FOR ASTIGMATISM BRAND CONTACT LENSES (CLS) ON SUNDAY (DATE REDACTED). THE PT REPORTED DISCOMFORT IN THE LEFT EYE (OS) ON MONDAY AND IMMEDIATELY REMOVED THE LENSES. ON TUESDAY, THE CONDITION OF THE EYE WAS ¿WORSE SO I SAW AN OPHTHALMOLOGIST WHO SAID I HAD A SERIOUS INFECTION AND SENT ME TO THE EYECARE EMERGENCY ROOM, WHERE I WAS DIAGNOSED WITH HAVING A CORNEAL INFECTION (ULCER/ABSCESS). I WAS IMMEDIATELY PUT ON ANTIBIOTIC DROPS TAKEN EVERY HOUR AROUND THE CLOCK. CULTURES WERE TAKEN WHICH IDENTIFIED THE PATHOGEN AS PSEUDONYMOUS. THIS IDENTIFICATION WAS CONFIRMED BY A LABORATORY ANALYSIS OF THE CONTACT LENSES THAT I HAD BEEN WEARING. I HAVE SINCE BEEN UNDER TREATMENT WITH MULTIPLE TRIPS TO THE EMERGENCY ROOM, ONE OF WHICH RESULTED IN A 3-DAY STAY IN THE HOSPITAL.¿ THE PT REPORTED ¿THE SITUATION NOW SEEMS TO BE UNDER CONTROL, BUT I AM LEFT WITH A PERMANENT SCAR IN MY CORNEA WHICH IMPACTS MY VISION.¿ NO ADDITIONAL DETAILS WERE PROVIDED. ON (B)(6) 2026, EMAILS WERE SENT TO THE PT REQUESTING ADDITIONAL DETAILS AND A PHONE NUMBER FOR FOLLOW-UP. THERE HAS BEEN NO RESPONSE FROM THE PT. NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. NO ADDITIONAL INFORMATION IS EXPECTED. THE LOT NUMBER OF THE SUSPECT PRODUCT IS UNKNOWN AND THE OS SUSPECT CLS WERE DISCARDED. NO ADDITIONAL EVALUATION CAN BE PERFORMED. IF ANY FURTHER RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE FILED, AS APPROPRIATE.