NEUTROGENA VISIBLY CLEAR LIGHT THERAPY ACNE MASK EU

Additional Manufacturer Narrative

JOHNSON & JOHNSON CONSUMER, INC. IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH JOHNSON & JOHNSON CONSUMER, INC. HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, JOHNSON & JOHNSON CONSUMER, INC. OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, JOHNSON & JOHNSON CONSUMER, INC., OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE FOLLOW-UP 01 MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

Additional Manufacturer Narrative

DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THIS REPORT IS FOR (NEUTROGENA VISIBLY CLEAR LIGHT THERAPY ACNE MASK EU 3574661329499). DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA (NTG LIGHT THERAPY ACNE MASK USA 070501101247 7050110124USA). LOT NUMBER IS NOT AVAILABLE. UDI # (B)(4), UPC = (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. WHILE HEADACHE ASSOCIATED WITH USE OF NEUTROGENA LIGHT THERAPY ACNE MASK MAY POSSIBLY BE CAUSED BY GLARE FROM THE LIGHTS, WHERE UNDERLYING REFRACTIVE OR ACCOMMODATIVE ERRORS MAY INCREASE SENSITIVITY, IT IS LIKELY TO BE MILD AND TRANSIENT. THE SEVERE HEADACHE AND ¿EYE BLURRINESS¿ REQUIRING HOSPITALIZATION WAS ATTRIBUTED TO SWELLING OF THE OPTIC NERVE AND NEUROLOGY DISORDER WHICH MAY PROVIDE ALTERNATE EXPLANATIONS. THERE IS VERY LIMITED INFORMATION TO DETERMINE OR CONCLUDE THAT THE EVENTS MENTIONED IN THE CASE ARE RELATED TO THE DISORDERS OF RETINA (SUCH AS RETINAL DEGENERATION OR OCULAR ALBINISM) IN SUSCEPTIBLE POPULATIONS. (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 MOTHER REPORTED AN EVENT ON BEHALF OF HER DAUGHTER WITH NTG LIGHT THERAPY ACNE MASK. HER DAUGHTER USED NTG LIGHT THERAPY MASK FOR AN UNSPECIFIED TIME, FREQUENCY AND DURATION AND EXPERIENCED SEVERE HEADACHES AND ¿EYE BLURRINESS¿. THE CONSUMER WAS ADMITTED TO HOSPITAL PER REFERRAL OF AN OPHTHALMOLOGIST DUE TO A SEVERE SWELLING OF HER OPTIC NERVE AND NEUROLOGY DISORDER. NO INFORMATION ON CONCOMITANT DISEASES OR MEDICAL HISTORY WERE MENTIONED. THERE ARE NO DETAILS REPORTED ON EXAMINATIONS CONDUCTED OR ANY RESULTS, DIAGNOSIS OR OUTCOME.