NEUTROGENA VISIBLY CLEAR LIGHT THERAPY ACNE MASK

Additional Manufacturer Narrative

PATIENT AGE AT TIME OF EVENT, WEIGHT, AND ETHNICITY AND RACE WERE NOT PROVIDED FOR REPORTING. THIS REPORT IS FOR (NEUTROGENA VISIBLY CLEAR LIGHT THERAPY ACNE MASK EU 3574661330617 LTCMA11836EUA LTCMA11836EUA). DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA (NTG LIGHT THERAPY ACNE MASK USA 70501101247 7050110124USB 7050110124USB). (B)(4), EXPIRATION DATE= NI, LOT NUMBER = NI. DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA (NTG LIGHT THERAPY ACNE MASK USA). DEVICE EVALUATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN AS PRODUCT WAS NOT RETURNED TO MANUFACTURER. DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED WITHOUT LOT NUMBER. AT THIS TIME, WITH LIMITED INFORMATION PROVIDED, THIS EVENT IS BEING REPORTED WITH AN OVERABUNDANCE OF CAUTION. THE NEUTROGENA LIGHT THERAPY ACNE MASK AND ACTIVATOR WERE VOLUNTARILY WITHDRAWN FROM THE MARKET AT THE DISTRIBUTOR AND RETAIL LEVEL (REFERENCE MARKET WITHDRAWAL: NEUTROGENA LIGHT THERAPY ACNE MASK, REPORT NUMBER: 2214133-04/24/2019-001-R RES# 83291). (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

Description of Event or Problem

A FEMALE CONSUMER REPORTED AN EVENT WITH THE NEUTROGENA VISIBLY CLEAR LIGHT THERAPY ACNE MASK. AT THE BEGINNING / MIDDLE OF 2018 (EXACT DATE UNKNOWN), THE CONSUMER PURCHASED THE NEUTROGENA ANTI ACNE MASK AND USED IT IRREGULARLY THROUGHOUT THE YEAR UNTIL TWO WEEKS AGO. OVER TIME, AN ULCER DEVELOPED IN THE EYE (¿HOLE IN THE CORNEA¿) (EXACT DATE OF ONSET UNKNOWN), WHICH THE CONSUMER DID NOT INITIALLY RELATE TO THE USE OF THE MASK. THE SYMPTOMS WERE EYE PAIN, NERVE PAIN, REDNESS, SWELLING, INTENSE SENSITIVITY TO LIGHT, WHICH MADE DRIVING IMPOSSIBLE. EVEN THE DOCTORS WHOM SHE WAS TREATED BY, COULD NOT RELATE THIS TO THE USAGE OF THE MASK, SINCE SHE DID NOT TELL THEM ABOUT IT. AFTER SOME TIME AND VARIOUS TREATMENT ATTEMPTS IN AN OPHTHALMOLOGIST'S PRACTICE IN (B)(6), THE CONSUMER HAD TO BE OPERATED ON IN THE EYE CLINIC IN KARLSRUHE (EXACT DATES AND TIMES ARE UNKNOWN). THE ULCER / HOLE IN THE CORNEA WAS CLOSED/RESOLVED DURING THIS OPERATION. THE USE OF THE MASK WAS THEN PAUSED AND THE CONSUMER NO LONGER HAD ANY COMPLAINTS. AROUND (B)(6) 2019, THE CONSUMER REUSED THE MASK AND THEN DEVELOPED PAIN IN THE OPERATED EYE AND INCREASED SENSITIVITY TO LIGHT. THE USE OF THE MASK WAS STOPPED IMMEDIATELY AND THE PATIENT APPLIED A PROTECTIVE LENS, THAT SHE HAD RECEIVED FOR EMERGENCIES AFTER THE OPERATION. THE SYMPTOMS SUBSIDED AFTER TWO DAYS AND THE PATIENT IS CURRENTLY SYMPTOM-FREE.