NEUTROGENA VISIBLY CLEAR LIGHT THERAPY ACNE MASK

Additional Manufacturer Narrative

DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. PATIENT IDENTIFIER, AGE AT TIME OF EVENT, GENDER, 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). UDI #: (B)(4), UPC: (B)(4), LOT NUMBER: NI, EXPIRATION DATE: 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/INVESTIGATION 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, THIS EVENT IS BEING REPORTED WITH AN OVERABUNDANCE OF CAUTION. THERE IS NO INDICATION THAT NEUTROGENA LIGHT THERAPY MASK MAY INDUCE REFRACTIVE ERRORS NEITHER CORNEAL CURVATURE CHANGES. THE NEUTROGENA LIGHT THERAPY ACNE MASK AND ACTIVATOR WERE VOLUNTARILY WITHDRAWN FROM THE MARKET AT THE DISTRIBUTOR AND RETAIL LEVEL (REFERENCE MARKET WITHDRAWAL: NEUTROGENA LIGHT THERAPY ACNE MASK, REPORT NUMBER: 2214133-04/24/2019-001-R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# (B)(4)). (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 CONSUMER REPORTED AN ADVERSE EVENT WITH THE NTG LIGHT THERAPY MASK. A CONSUMER OF UNSPECIFIED AGE AND GENDER WHO USED THE NTG LIGHT THERAPY MASK INITIALLY TWICE A WEEK FOR 2 WEEKS FOLLOWED BY EVERY DAY USAGE AFTER THAT. RIGHT AFTER THE FIRST TREATMENT, THE CONSUMER NOTICED THAT HIS/HER EYESIGHT WAS CHANGING (REFERRED AS SPONGY VISION AFTER USING THE MASK) AND AFTER 1 MONTH COULD NO LONGER SEE WELL. THE LIGHT MASK USAGE WAS INTERRUPTED. THE CONSUMER FURTHER EXPLAINED THAT HIS/HER VISION OF -4.5 ENDED UP AT -5.00 AND THAT AN OPTICIAN DIAGNOSED A CORNEAL CURVATURE IN HER LEFT EYE NOT FURTHER SPECIFIED. THERE ARE NO DETAILS ON THE MEDICAL HISTORY, USE OF ANY CONCOMITANT MEDICATIONS, ACCOMPANYING SIGN AND SYMPTOMS AND FINAL DIAGNOSIS. OUTCOME AND TREATMENT WERE NOT REPORTED.