ACUVUE® OASYS MAX 1-DAY MULTIFOCAL FOR ASTIGMATISM

Description of Event or Problem

ON 11JUN2026, A JOHNSON AND JOHNSON ACCOUNT MANAGER REPORTED A PRODUCT COMPLAINT WAS RECEIVED FROM AN OPTICAL STORE IN SPAIN REGARDING THE ACUVUE® OASYS MAX 1-DAY MULTIFOCAL FOR ASTIGMATISM BRAND CONTACT LENS (CL). NO ADDITIONAL DETAILS WERE PROVIDED. ON 15JUN2026, THE JOHNSON AND JOHNSON ACCOUNT MANAGER PROVIDED ADDITIONAL INFORMATION. THE REPRESENTATIVE PROVIDED THE ACCOUNT INFORMATION TO CONTACT FOR ADDITIONAL DETAILS. THE EVENT OCCURRED IN THE FIRST WEEK OF (B)(6) 2026. NO ADDITIONAL DETAILS ARE KNOWN. ON (B)(6) 2026, AN EYE CARE PROFESSIONAL (ECP) AT AN OPTICAL STORE IN SPAIN REPORTED THAT A PATIENT (PT) EXPERIENCED DISCOMFORT IN THE RIGHT EYE (OD) AND ¿DEVELOPED A CORNEAL ULCER ON OD¿ WHILE WEARING ACUVUE® OASYS MAX 1-DAY MULTIFOCAL FOR ASTIGMATISM BRAND CL. THE ECP REPORTED THAT THE ¿PT IS A DOCTOR AND PT WAS DIAGNOSED WITH KERATITIS BY ONE OF PT¿S COLLEAGUES.¿ THE PT REPORTEDLY SWITCHED TO THE CL BRAND AND SUBSEQUENTLY EXPERIENCED DISCOMFORT OD, WITH THE EVENT OCCURRING ¿BETWEEN THE END OF MAY AND BEGINNING OF JUNE.¿ NO MEDICAL REPORT WAS AVAILABLE, AND NO FURTHER CLINICAL INFORMATION WAS PROVIDED. THE PT'S OD CORNEAL ULCER EVENT WAS DETERMINED TO BE A SERIOUS ADVERSE EVENT ON (B)(6) 2026 AS WE WERE UNABLE TO VERIFY THE PT'S DIAGNOSIS AND TREATMENT WITH THE TREATING ECP. ON (B)(6) 2026, ADDITIONAL INFORMATION WAS RECEIVED FROM THE REPORTING ECP. THE ECP DOES NOT THINK A MEDICAL REPORT IS AVAILABLE AS THE PT IS A DOCTOR AND WAS DIAGNOSED BY A COLLEAGUE. THE ECP REPORTED THE PT ¿DIDN¿T FOLLOW ANY TREATMENT, THE PT JUST USED SOME EYE DROPS FOR A FEW DAYS UNTIL THE EYE IMPROVED.¿ THE CORNEAL ULCER WAS ¿LOCATED ON THE UPPER SIDE OF THE CORNEA.¿ THE ECP REFUSED TO CONTACT THE PT AGAIN REGARDING THIS EVENT AS THE OD IS ¿FINE NOW¿ AND THERE IS NO SCAR OR VISION LOSS. NO ADDITIONAL MEDICAL INFORMATION WAS PROVIDED. NO ADDITIONAL INFORMATION IS EXPECTED. THE DATE OF EVENT WILL BE REPORTED AS 01MAY2026 AS THE EXACT DATE OF EVENT IS UNKNOWN. A COMPREHENSIVE REVIEW OF THE MANUFACTURING RECORDS FOR LOT NUMBER B0194RH 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. THE OD SUSPECT CL IS NOT AVAILABLE FOR RETURN FOR EVALUATION. NO ADDITIONAL EVALUATION CAN BE CONDUCTED. IF ANY FURTHER RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE FILED, AS APPROPRIATE.