NEUTROGENA® LIGHT THERAPY ACNE MASK

Additional Manufacturer Narrative

DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DATE OF BIRTH AND WEIGHT WERE NOT PROVIDED FOR REPORTING. EXACT DATE OF THE EVENT IS UNKNOWN. CONSUMER REPORTED THE EVENT OCCURRED SEVERAL WEEKS PRIOR TO THE J AND J AWARENESS DATE. (B)(4). DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. DEVICE HISTORY RECORDS REVIEW WAS COMPLETED. NO NON CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORDS SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

Description of Event or Problem

ON AN UNSPECIFIED DATE, IN 2017, FEW WEEKS PRIOR TO REPORTING, THE CONSUMER STARTED USING NEUTROGENA LIGHT THERAPY ACNE MASK. AFTER USING IT FOR ABOUT 10 SECONDS HER EYES STARTED BURNING AND HURTING. SHE TRIED IT FOR ANOTHER SHORT WHILE (LESS THAN A MINUTE) WITH A THICK SOCK COVERING EYES BUT IT WAS STILL PAINFUL. AFTERWARDS HER VISION WAS BLURRY, EYES WERE PAINFUL AND EYELIDS WERE HOT AND PUFFY. ON AN UNSPECIFIED DATE, IN 2017, SHE VISITED ER (EMERGENCY ROOM) WHERE SHE WAS DIAGNOSED WITH OPTIC NEURITIS. SHE WAS PRESCRIBED UNSPECIFIED OINTMENT TO PUT IN EYES. WHILE REPORTING THE CONSUMER MENTIONED THAT HER VISION MOSTLY RETURNED TO NORMAL ALTHOUGH THERE STILL WAS SOME EXCESSIVE LIGHT SENSITIVITY.