Description of Event or Problem · 0
ON (B)(6) 2026, A PATIENT (PT) IN CHINA CALLED TO REPORT PAIN IN THE LEFT EYE (OS) WHILE WEARING AN ACUVUE® OASYS® 1-DAY WITH HYDRALUXE¿ FOR ASTIGMATISM BRAND CONTACT LENS (CL) ON (B)(6) 2026. THE PT REPORTED THE PAIN PERSISTED AFTER REMOVING THE OS SUSPECT CL, SO THE PT PRESENTED TO AN EYE CARE PROFESSIONAL (ECP), (DATE NOT PROVIDED) WHO DIAGNOSED THE PT WITH ¿INFLAMMATION.¿ THE PT WAS PRESCRIBED TOBRAMYCIN AND DEXAMETHASONE OPHTHALMIC OINTMENT 0.1 GRAM (G) AT NIGHT, TOBRAMYCIN AND DEXAMETHASONE OPHTHALMIC SUSPENSION 1 DROP, 4 TIMES DAILY (QID), AND DICLOFENAC SODIUM EYE DROPS ¿1 DAY 1 TIME, 1 DROP EACH TIME.¿ THE PT REPORTED THE OS HAS NOT YET RECOVERED. THE PT WILL SEND THE MEDICAL REPORT FOR REVIEW. ON 27MAR2026, THE PT PROVIDED AN EMAIL WITH 4 PICTURES WHICH WERE SENT FOR TRANSLATION. ON (B)(6) 2026, TRANSLATION WAS PROVIDED FOR EYE DROPS PRESCRIBED. THE PT PROVIDED 4 MEDICAL INVOICES, NO MEDICAL INFORMATION PROVIDED. THE PT ALSO PROVIDED PRESCRIPTIONS, DATED: 15FEB2026; ¿PRESCRIPTION: REGULARY EXAMINATION: TOBRAMYCIN AND DEXAMETHASONE EYE GEL; TOBRAMYCIN AND DEXAMETHASONE EYE DROPS; DICLOFENAC SODIUM EYE DROPS.¿ NO FREQUENCY OF THE MEDICATIONS WAS PROVIDED. ON 29MAR2026, THE PT PROVIDED ADDITIONAL INFORMATION. THE PT SENT AN EMAIL WITH A PICTURE OF ¿MEDICATION GUIDE WITH INDICATION OF DIAGNOSIS: SCLERITIS.¿ WITH THE RECEIPT OF THE ADDITIONAL INFORMATION RECEIVED BY THE PT ON 29MAR2026, THE PT¿S OS SCLERITIS WAS DETERMINED TO BE A SERIOUS ADVERSE EVENT. ON 30MAR2026, MEDICAL TRANSLATION WAS RECEIVED FOR THE PT¿S MEDICAL DOCUMENT. HOSPITAL VISIT DATE: (B)(6) 2026; DIAGNOSIS: SCLERITIS PRESCRIPTION: TOBRAMYCIN AND DEXAMETHASONE EYE GEL 3.5G, APPLY 0.1 G AT NIGHT; TOBRAMYCIN AND DEXAMETHASONE EYE DROPS, 1 DROP, QID; DICLOFENAC SODIUM EYE DROPS, 1 DROP QID. ON 01APR2026, ADDITIONAL INFORMATION WAS PROVIDED REGARDING MEDICAL DOCUMENT TRANSLATION. THE MEDICAL DOCUMENT PROVIDED BY THE PT DID NOT INDICATE WHICH EYE WAS AFFECTED, BUT THE PRESCRIPTIONS INDICATE THAT THE MEDICATIONS WERE TO BE APPLIED TO THE OS. ADDITIONAL MEDICAL INFORMATION WAS REQUESTED FROM THE PT ON 01APR2026. NO ADDITIONAL MEDICAL INFORMATION HAS BEEN RECEIVED. A COMPREHENSIVE REVIEW OF THE MANUFACTURING RECORDS FOR LOT NUMBER L007743 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 OS 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.