Description of Event or Problem · 0
ON (B)(6) 2026, AN EMAIL WAS RECEIVED FROM A JOHNSON AND JOHNSON VISION CARE INC. EMPLOYEE WITH NOTIFICATION OF A NATIONAL CENTER FOR MEDICAL DEVICES REPORTING (NCMDR) SUBMISSION FROM THE SAUDI FOOD AND DRUG AUTHORITY (SFDA). THE SFDA NOTIFICATION DATED (B)(6) 2026 WAS ATTACHED ALONG WITH PHOTOS OF THE SUSPECT PRODUCT CARTONS AND BLISTER PACKAGES, A MEDICAL REPORT, AND A PRESCRIPTION. PER THE SFDA NOTIFICATION, A CUSTOMER REPORTED REDNESS, PAIN IN THE EYE, INABILITY TO OPEN THE EYE, AND "DIFFICULTY IN OBTAINING ACCURATE VISION READINGS" WHILE WEARING ACUVUE® OASYS® FOR ASTIGMATISM BRAND CONTACT LENSES (CLS) IN BOTH EYES. A MICROBIOLOGY REPORT WAS ATTACHED "INDICATING THE PRESENCE OF BACTERIA IN THE LENSES, RESULTING IN SEVERE INFLAMMATION AND EYE DAMAGE." NO ADDITIONAL INFORMATION WAS PROVIDED. ON (B)(6) 2026, THE CUSTOMER WAS CALLED AND PROVIDED ADDITIONAL INFORMATION. THE EVENT OCCURRED IN OCTOBER (EXACT DATE UNKNOWN), IN BOTH EYES (OU), AFTER 4-5 HOURS OF CL WEAR. THE CUSTOMER "IMMEDIATELY" VISITED AN OPTOMETRIST, WAS DIAGNOSED WITH "BACTERIAL RETINAL INFECTION ATTRIBUTED TO THE LENS," AND WAS PRESCRIBED ANTIBIOTIC EYE DROPS (NAME AND FREQUENCY OF USE NOT PROVIDED). THE CUSTOMER WAS NOT PROFESSIONALLY FIT AND PRESCRIBED ACUVUE OASYS FOR ASTIGMATISM LENSES AND THIS WAS THE FIRST TIME USING JNJ LENSES AS "THEY WERE SUGGESTED BY THE STORE." THE PRESCRIPTION PROVIDED WAS FOR SPECTACLES. THE CUSTOMER PROVIDED BOTH LENSES TO THE OPTOMETRIST FOR MICROBIOLOGICAL TESTING, BUT IS NOT SURE WHICH EYE WAS RECORDED IN THE REPORT. THE PATIENT DOES NOT SLEEP IN LENSES AND USES EYEWA SOLUTION TO DISINFECT THE LENSES OVERNIGHT. THE CUSTOMER NOTICED NOTHING UNUSUAL WITH THE LENSES UPON OPENING THE BLISTER PACKAGE OR AFTER REMOVAL FROM THE EYES. THE LENSES WERE NOT EXPOSED TO A WATER SOURCE DURING WEAR. NO ADDITIONAL MEDICAL INFORMATION HAS BEEN RECEIVED. NO ADDITIONAL INFORMATION IS EXPECTED. THE DATE OF THE PT¿S EVENT IS BEING REPORTED AS 01OCT2025 AS THE EXACT EVENT DATE IS UNKNOWN. THIS REPORT IS FOR THE PT¿S RIGHT EYE (OD) EVENT. A SEPARATE REPORT WILL BE SUBMITTED FOR THE PT¿S LEFT EYE (OS) EVENT. A COMPREHENSIVE REVIEW OF THE MANUFACTURING RECORDS FOR LOT NUMBER B016SXM 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 SUSPECT OD CL WAS DISCARDED. NO ADDITIONAL EVALUATION CAN BE CONDUCTED. IF ANY FURTHER RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE FILED, AS APPROPRIATE.