NEUTROGENA VISIBLY CLEAR LIGHT THERAPY ACNE MASK

Additional Manufacturer Narrative

DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. PATIENT IDENTIFIER, WEIGHT AND ETHNICITY AND RACE WERE NOT PROVIDED FOR REPORTING. THIS REPORT IS FOR (NEUTROGENA VISIBLY CLEAR LIGHT THERAPY ACNE MASK EU 3574661359182 LTCMA91806EUA LTCMA91806EUA). DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA (NTG LIGHT THERAPY ACNE MASK KIT USA 70501101247 7050110124USA 7050110124USA). (B)(4). 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 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 AND PRODUCT WAS MANUFACTURED PER SPECIFICATION. THE PRODUCT WAS MANUFACTURED ON DECEMBER 7, 2017. AT THIS TIME, WITH LIMITED INFORMATION PROVIDED, THIS EVENT IS BEING REPORTED WITH AN OVERABUNDANCE OF CAUTION. (B)(4). THE NEUTROGENA LIGHT THERAPY ACNE MASK AND ACTIVATOR WERE VOLUNTARILY WITHDRAWN FROM THE MARKET AT THE DISTRIBUTOR AND RETAIL LEVEL (REFERENCE MARKET WITHDRAWAL: NEUTROGENA LIGHT THERAPY ACNE MASK, REPORT NUMBER: (B)(4).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

THIS CASE WAS RECEIVED FROM A (B)(6) YEAR OLD MALE CONSUMER WHO USED THE NTG LIGHT THERAPY MASK FOR MODERATE ACNE AND RESIDUAL MARKS ONCE A DAY AS INDICATED IN THE INSTRUCTIONS (STARTING ON AN UNSPECIFIED DATE IN 2017 UNTIL (B)(6) 2020). THE CONSUMER REPORTED THAT HE DEVELOPED SYMPTOMS INCLUDING ¿BLACK SPECKS FLOATING IN THE EYE,¿ WHILE WEARING THE MASK AND AT THE END OF EACH SESSION, HE SAW ALL BLUISH PURPLE. THE CONSUMER ALSO MENTIONED EXPERIENCING DISCOMFORT IN THE EYES, DIZZINESS, ITCHING, HEADACHE AND DRYNESS OF HIS EYES, EYELID AND SKIN. ON AN UNSPECIFIED TIME AND DATE, HE WAS INFORMED BY AN OPHTHALMOLOGIST THAT HIS EYESIGHT WAS GETTING WORSE. HE VISITED AN OCULIST ON AN UNSPECIFIED TIME AND TEST AND UNDERWENT SEVERAL TESTS WHICH SHOWED THAT THERE HAS BEEN A ¿HOLE IN THE RETINA IN THE LEFT EYE¿, ASTIGMATISM, ¿SIGNIFICANT¿ INCREASE IN MYOPIA. HE WAS TREATED WITH UNSPECIFIED LASER TREATMENT FOR THE HOLE IN THE RETINA, UNSPECIFIED DROPS FOR DRYNESS AND DISCOMFORT AND ADVISED REST FOR THE EYES. THERE WAS NO INFORMATION OF PAST MEDICAL/ OCULAR HISTORY. THERE ARE NO DETAILS ON THE DIAGNOSIS OF THE ¿HOLE IN THE RETINA¿ AND THE OUTCOME OF THE LASER TREATMENT. THERE IS NO AVAILABLE INFORMATION ON THE ASTIGMATISM AND MYOPIA INCLUDING THE TREATMENT AND OUTCOME.