Description of Event or Problem · 0
ON 06AUG2025, A JOHNSON AND JOHNSON EMPLOYEE REPORTED A PATIENT (PT) WEARING AN ACUVUE® ABILITI¿ OVERNIGHT BRAND CONTACT LENS (CL) PRESENTED TO AN EYE CARE PROFESSIONAL (ECP) ON (B)(6) 2025 WITH PAIN AND WATERY EYES. THE ECP DIAGNOSED A SMALL, CENTRAL CORNEAL ULCER. THE PT LAST WORE THE CL ON (B)(6) 2025 AND THE SYMPTOMS STARTED ON (B)(6) 2025. THE PT WAS ADVISED TO DISCONTINUE LENS WEAR AND WAS TREATED WITH VIGAMOX (DOSAGE AND FREQUENCY NOT PROVIDED). ON 19AUG2025, A FAX (WITH SECTIONS NOT LEGIBLE) WAS RECEIVED FROM THE ECP. SYMPTOMS WERE NOTICED ON (B)(6) 2025. THE PT WAS SEEN BY THE ECP ON (B)(6) 2025 AND TREATED WITH VIGAMOX EVERY 2 HOURS (Q2H) FOR AN OD CENTRAL CORNEAL ULCER, INFERIOR. ON 21AUG2025, ADDITIONAL INFORMATION WAS RECEIVED FROM THE JOHNSON AND JOHNSON EMPLOYEE. THE PT HAS A FOLLOW UP APPOINTMENT NEXT WEEK. PER THE ECP, ¿STILL WORKING ON DECREASING THE SCAR.¿ ON 25AUG2025, THE ECP PROVIDED ADDITIONAL INFORMATION BY EMAIL. A PT PRESENTED TO ECP ON (B)(6) 2025 WITH REDNESS, PAIN, BLURRINESS AND WATERY EYES SINCE (B)(6) 2025. THE PT "COULD NOT WEAR LENS." PT WAS DIAGNOSED WITH A SMALL, CENTRAL, INFERIOR OD CORNEAL ULCER AND WAS PRESCRIBED VIGAMOX Q2H. THE EVENT HAS NOT RESOLVED; "STILL WORKING ON DECREASING SCARRING." THE PT CLEANS AND REPLACES LENS DAILY. NO ADDITIONAL MEDICAL INFORMATION HAS BEEN RECEIVED. THE SUSPECT LOT NUMBER WAS REPORTED AS 25131437R1. THE MANUFACTURER REPORTED THERE WERE NO DEVIATIONS FOUND FOR LOT NUMBER 25131437R1. THE SUSPECT CL HAS BEEN REQUESTED FOR RETURN; HOWEVER, HAS NOT BEEN RECEIVED. IF ANY FURTHER RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE FILED, AS APPROPRIATE.