Description of Event or Problem · 0
ON 02MAR2026, AN EMAIL WAS RECEIVED FROM A JOHNSON AND JOHNSON VISION CARE INC. EMPLOYEE WHERE A PATIENT (PT) IN THE UNITED KINGDOM REPORTED OF A "SERIOUS I INFECTION AFTER WEARING MY LENSES AND WAS TOLD THAT I HAVE PERIPHERAL CONTACT LENS ULCER." THE PT REPORTED WEARING ACUVUE® OASYS® BRAND CONTACT LENSES (CLS). THE AFFECTED EYE IS UNKNOWN. ON (B)(6) 2026, THE PT SENT AN EMAIL WITH NOTIFICATION OF LOCATION AS SOUTH AFRICA. ON (B)(6) 2026, A DISTRIBUTOR REPORTED FOLLOW-UP INFORMATION OBTAINED FROM THE PATIENT (PT). THE EVENT OCCURRED IN SOUTH AFRICA. THE PATIENT EXPERIENCED OCULAR SCRATCHINESS FOLLOWING "MULTIPLE DAYS" OF CONTACT LENS (CL) WEAR. AFTER ONE TO TWO DAYS, THE PATIENT CONSULTED AN OPTOMETRIST (EXACT DATE UNKNOWN) AND WAS DIAGNOSED WITH A LEFT EYE (OS) PERIPHERAL CORNEAL ULCER WITH A "SLIGHT INFECTION." THE PATIENT WAS PRESCRIBED VIDAMOGS AND TORAN EYE DROPS TO BE ADMINISTERED HOURLY FOR ONE WEEK. DUE TO INABILITY TO ATTEND A FOLLOW-UP VISIT, THE PATIENT WAS ADVISED TO CONTINUE THE PRESCRIBED TREATMENT AND DISCONTINUE CL WEAR. A MEDICAL REPORT IS UNAVAILABLE. THE PT REPORTED "TODAY IT IS GETTING BETTER." THE PATIENT¿S LAST ANNUAL EYE EXAMINATION OCCURRED IN (B)(6) OR (B)(6) 2025, AT WHICH TIME SLIT LAMP EVALUATION SHOWED NO SIGNS OF INFECTION OR CORNEAL ULCERATION. THE PATIENT WAS PROFESSIONALLY FIT WITH ACUVUE OASYS CONTACT LENSES AND DENIED OVERNIGHT LENS WEAR. ON (B)(6) 2026, ADDITIONAL INFORMATION WAS RECEIVED FROM THE DISTRIBUTOR. THE PT REPORTED NO ISSUES WITH THE ACUVUE® OASYS® BRAND CLS FROM LOT NUMBERS L006R8L AND L006NT6, WHICH WERE PROVIDED BY THE OPTOMETRIST DURING CONSULTATION RELATED TO THE REPORTED EVENT. THE PT DID NOT EXPRESS ANY COMPLAINTS REGARDING THESE LENSES, WHICH WERE ASSOCIATED WITH A NEWLY ISSUED PRESCRIPTION, NOR DID THE PT ATTRIBUTE ANY HARM TO THEIR USE. ALL SUSPECT PRODUCT PACKAGING AND LENSES WERE DISCARDED, AND THE PT HAS BEEN WEARING SPECTACLES AS ADVISED BY THE OPTOMETRIST. THE PRESENCE OF ANY ONGOING OR ADDITIONAL SYMPTOMS REMAINS UNKNOWN. NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. NO ADDITIONAL INFORMATION IS EXPECTED. THIS "EYE INFECTION" IS BEING REPORTED AS THE PT¿S DIAGNOSIS AND TREATMENT COULD NOT BE VERIFIED WITH THE TREATING ECP AND IS UNCONFIRMED. THE DATE OF THE PT¿S EVENT IS BEING REPORTED AS (B)(6) 2026 AS THE EXACT EVENT DATE IS UNKNOWN. THE PT REPORTED LOT NUMBERS FROM 2 CARTONS (L006R8L AND L006NT6). IT IS UNKNOWN WHICH IS THE SUSPECT LOT NUMBER; THEREFORE, THE LOT NUMBER IS BEING SUBMITTED AS UNKNOWN. A COMPREHENSIVE REVIEW OF THE MANUFACTURING RECORDS FOR LOT NUMBERS L006R8L AND L006NT6 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. AVAILABILITY OF THE SUSPECT CLS IS UNKNOWN. NO ADDITIONAL EVALUATION CAN BE PERFORMED. IF ANY FURTHER RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE FILED, AS APPROPRIATE.