ACUVUE® OASYS®

Description of Event or Problem

On (b)(6) 2026, a family member called to report a patient (Pt) in Japan experienced ocular discomfort in the left eye (OS) in (b)(6) 2026 (exact event date not provided), while wearing an Acuvue® Oasys® Brand Contact Lens (CL). The Pt ¿continued to wear the lens for one week¿ and developed hyperemia after removing the CL. The Pt sought medical attention at an Eye Clinic and was diagnosed with ¿Inflammation on the back of the eyeball¿. The Pt was prescribed ¿Fluorometron¿ four times a day (QID) and ¿Gatiflo¿ QID for unknown duration. The Pt was instructed to discontinue CL wear for one week and revisit the Eye Clinic in (b)(6) 2026. During the Eye Clinic visit in (b)(6) 2026, the Pt was referred to a hospital for a physical examination because of the ¿inflammation on the back of the eyeball¿. The Pt visited the hospital in (b)(6) 2026 (exact date not provided), a blood test showed ¿some kidney-related findings¿ and the Pt was not instructed to revisit the hospital.On (b)(6) 2026, additional information was received from the Eye Clinic. The Pt was diagnosed with Uveitis in both eyes (OU) with no effect on visual acuity and prescribed Fluorometholone Ophthalmic Suspension and Gatifloxacin Ophthalmic Solution ¿for treatment of the inside of the eye¿( frequency and duration were not provided). No causal relationship with CL was identified. Follow up observation was requested at the hospital since the condition involved ¿the inside of both eyes¿. On (b)(6) 2026, a family member reported the Pt has not visited an ophthalmologist but planned to visit ¿within the next week,¿ there were ¿no eye drops left¿ and the Pt had no underlying disease.The date of the Pt¿s event is being reported as (b)(6) 2026 as the exact event date is unknown. This event was determined to be serious adverse event on (b)(6) 2026 upon receipt of the Pt¿s diagnosis of "OU uveitis."This report is for the Pt's right eye (OD) event. A separate report will be filed for the Pt's left eye (OS) event.The suspect OD Lot number is unknown. The OD suspect CL was discarded. No additional evaluation can be performed. If any further relevant information is received, a supplemental report will be filed, as appropriate.

Additional Manufacturer Narrative

On (b)(6) 2026, the patient's (Pt's) family member provided additional information. The Pt initially visited a clinic in (b)(6) 2026 and was advised to return for a follow-up visit in (b)(6) 2026. The Pt has no current symptoms and no plans to revisit the clinic. No additional information has been received. No additional information is expected. If any further relevant information is received, a supplemental report will be filed, as appropriate.