ACUVUE® OASYS®

Description of Event or Problem

ON (B)(6) 2026, A PATIENT (PT) IN ARGENTINA CALLED TO REPORT AN ACUVUE® OASYS® BRAND CONTACT LENS (CL) CAUSED DRY EYES AND AN ULCER IN THE LEFT EYE (OS) AFTER 1 WEEK AND 1 DAY OF CL USE. THE PT REPORTED A SENSATION THAT THE LENSES ¿SQUEEZE THE EYE.¿ THE PT REPORTED USING THE ACUVUE LENS IN COMBINATION WITH A HARD CONTACT LENS AS A PIGGYBACK LENS. THE PT USES ¿COOLTERS EYE DROPS¿ AND XALACON EYE DROPS EVERY NIGHT FOR ¿ARTERIAL PRESSURE.¿ THE PT VISITED AN EYE CARE PROFESSIONAL (ECP) DUE TO THIS ISSUE AND WAS ADVISED TO ¿REST THE EYES AND USE EYE DROPS.¿ ON (B)(6) 2026, THE PT PROVIDED ADDITIONAL INFORMATION. THE PT REPORTED DRYNESS AND DISCOMFORT ON (B)(6) 2026 AFTER WEARING A CL IN THE OS FOR A WEEK. THE PT DISCARDED THE OS SUSPECT CL AND TRIED A NEW CL, BUT SYMPTOMS PERSISTED. THE PATIENT VISITED THE OPTICAL STORE/CONTACTOLOGIST, WHERE AN ¿ULCER¿ WAS REPORTEDLY MENTIONED; HOWEVER, THE PATIENT COULD NOT CONFIRM WHETHER AN ULCER WAS DIAGNOSED OR IF THE DRYNESS AND DISCOMFORT COULD CAUSE AN ULCER. THE PATIENT WAS ADVISED TO REST THE EYES, USE COOL TEARS LUBRICATING DROPS AS NEEDED, AND CONTINUE XALACON EYE DROPS NIGHTLY FOR HIGH OCULAR PRESSURE. THE PT REPORTED REMOVING LENSES NIGHTLY, WEARING LENSES FOR 15¿18 DAYS, SEASON DEPENDENT, AND CLEANING THE CLS DAILY WITH OPTI-FREE SOLUTION. THE PT ALSO REPORTED BATHING WHILE WEARING CLS. THE PATIENT DECLINED TO PROVIDE THE OPTICAL STORE¿S CONTACT INFORMATION UNTIL SPEAKING DIRECTLY WITH THE OPTICAL STORE. FOLLOW-UP ATTEMPTS TO THE PT ON (B)(6) 2026, AND (B)(6) 2023 WERE UNSUCCESSFUL, AND NO ADDITIONAL INFORMATION WAS RECEIVED. THE OS CORNEAL ULCER EVENT AND ASSOCIATED TREATMENT COULD NOT BE VERIFIED WITH THE ECP; THEREFORE, THE EVENT WILL BE SUBMITTED AS UNCONFIRMED. A COMPREHENSIVE REVIEW OF THE MANUFACTURING RECORDS FOR LOT NUMBER B016BHK WAS CONDUCTED, INCLUDING ALL RELEVANT ASPECTS SUCH AS PARAMETERS RESULTS, PACKAGING AUDITS, PACKAGE INTEGRITY ASSESSMENTS, IDENTIFICATION OF NONCONFORMITIES, RECORDED DEVIATIONS, AND STERILIZATION PROCESSES. THIS ASSESSMENT CONFIRMS THAT ALL UNITS COMPLIED WITH THE SPECIFIED CRITERIA AND WERE RELEASED IN ACCORDANCE WITH ESTABLISHED PRODUCT SPECIFICATIONS. IT IS UNKNOWN WHETHER THE SUSPECT OS LENS WILL BE RETURNED FOR EVALUATION. IF ANY FURTHER RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE FILED, AS APPROPRIATE.