NEUTROGENA VISIBLY CLEAR LIGHT THERAPY ACNE MASK

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. ADDITIONAL INFORMATION: H4, H6: 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 JULY 11, 2017. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE FOLLOW-UP #1 MEDWATCH, AN ADDITIONAL FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

Description of Event or Problem

ADDITIONAL INFORMATION WAS RECEIVED ON MARCH 22, 2021 BY THE CONSUMER & APOS'S OPTICIAN. OPTICIAN STATED THE CONSUMER DID NOT PURCHASE MASK FROM THEM AND DID NOT SEE THE PATIENT AFTER HAVING ISSUES WITH MASK. THEY STATED THEY USED TO PROVIDE THE PATIENT WITH CONTACT LENSES. OPTICIAN STATED THEY DON'T SUPPLY COSMETIC PRODUCTS TO THE CONSUMERS. THE CONSUMER WAS DIAGNOSED FOR: DRY EYES. THERE IS NO MENTION OF LASER SURGERY. NO FURTHER DETAILS OR INFORMATION WAS PROVIDED.

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 3574661329499 LTCMA11827EUA LTCMA11827EUA). 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 - 3574661329499, LOT #-1927KS06, EXP DATE ¿ 30-JUN-2020. 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 HAS BEEN REQUESTED. AT THIS TIME, THIS EVENT IS BEING REPORTED WITH AN OVERABUNDANCE OF CAUTION. AT THIS TIME, THIS EVENT IS BEING REPORTED WITH AN OVERABUNDANCE OF CAUTION. THERE IS NO INDICATION THAT NEUTROGENA LIGHT THERAPY MASK CAUSED ¿ISSUES WITH HER EYES¿ WHICH SHE HAD TO HAVE ¿LASER SURGERY¿. ALTHOUGH THE CONSUMER THOUGHT THE ¿EYE ISSUES¿ AND ¿LASER SURGERY¿ MAY HAVE RESULTED FROM USING THE PRODUCT, THE ACTUAL TIME TO ONSET OF THE EVENTS AND PRODUCT USE HAS NOT BEEN PROVIDED, TO ESTABLISH A TEMPORAL RELATIONSHIP BETWEEN THE EVENT AND THE PRODUCT. FURTHERMORE, THERE ARE NO DETAILS ON THE AGE OF THE CONSUMER, MEDICAL HISTORY, ACCOMPANYING SIGNS AND SYMPTOMS, PROGRESSION OF THE CONDITION/ VISION ISSUES AND THE RESULTS OF DIAGNOSTICS DONE AND THE DIAGNOSIS. IN ADDITION, THERE IS NO INFORMATION ON THE INDICATION AND OUTCOME OF THE LASER SURGERY THAT WAS DONE. THERE IS INSUFFICIENT INFORMATION AVAILABLE TO PROVIDE A LINK BETWEEN THE DEVICE AND THE INCIDENTS. EVENT IS BEING REPORTED AS THE CONSUMER RECEIVED MEDICAL INTERVENTION (LASER SURGERY). 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). 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 OF UNSPECIFIED AGE REPORTED SHE HAD EXPERIENCED ¿ISSUES WITH HER EYES¿ WHICH SHE HAD TO HAVE ¿LASER SURGERY¿ AFTER USING NTG VISIBLY CLEAR LIGHT THERAPY MASK FOR AN UNSPECIFIED TIME, FREQUENCY AND DURATION. THERE ARE NO DETAILS ON ACCOMPANYING SIGNS AND SYMPTOMS AND PROGRESSION OF THE DISEASE. THE CONSUMER VISITED AN OPTICIAN BUT THERE IS NO INFORMATION RECEIVED AT THIS TIME, ON THE CONSULTATION DETAILS, ANY EXAMINATIONS CONDUCTED/ THE RESULTS OF WHICH OR THE DIAGNOSIS, TREATMENT AND THE OUTCOME OF THE TREATMENT/ SURGERY. THERE IS ALSO NO INFORMATION ON PRE-EXISTING DISEASES, CONCOMITANT MEDICATIONS BEING TAKEN OR MEDICAL HISTORY.