NEUTROGENA VISIBLY CLEAR LIGHT THERAPY ACNE MASK EU

Additional Manufacturer Narrative

DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. PATIENT AGE AT TIME OF EVENT, WEIGHT AND ETHNICITY AND RACE WERE NOT PROVIDED FOR REPORTING. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA (NTG LIGHT THERAPY ACNE MASK USA). THIS REPORT IS FOR (NEUTROGENA VISIBLY CLEAR LIGHT THERAPY ACNE MASK EU). 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). EXPIRATION DATE= (17) 04/30/2020. LOT NUMBER = (10) 1287KS06. THE DEVICE WAS RECEIVED AND THE PRODUCT EVALUATION IS IN PROGRESS. NO CONCLUSION CAN BE DRAWN. A VISUAL INSPECTION OF THE DEVICE DOES NOT SHOW ANY ANOMALIES AND THE REPORTED LOT NUMBER IS THE SAME AS ON THE PRODUCT RECEIVED. WHEN THE CABLE WAS PLUGGED INTO THE ACTIVATOR IT SHOWED 29 SESSIONS REMAINING. A 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. 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 SHE TRIED THE NEUTROGENA VISIBLY CLEAR LIGHT THERAPY ACNE MASK FOR ACNE TREATMENT ON (B)(6) 2018 AND IT DISTURBED HER EYES. SHE USED THE PRODUCT ONCE BUT HAD 4 OCCASIONS WHEN SHE LOST HER VISION FOR APPROXIMATELY 5 MINUTES. CONSUMER HAS REPORTED THAT SHE HAD EYE SURGERY PRIOR TO USING THE MASK ON (B)(6) 2016. THIS WAS A LASER SURGERY TO CORRECT DEFECTIVE VISION. SHE SAID THAT AFTER THAT SURGERY, SHE ALREADY HAD GENERAL LIGHT SENSITIVITY AND A FEW OCCASIONS, WHERE SHE "UNREGULARLY" LOST VISIONS FOR SHORT TIMES (E.G. ALSO IN BRIGHT SUN LIGHT). THE NEUTROGENA VISIBLY CLEAR LIGHT THERAPY ACNE MASK WAS USED ONLY ONCE ON (B)(6) 2018 WITH CLOSED EYES. AFTERWARDS SHE HAD AGAIN LOSS OF VISION, UNREGULARLY FOR IN TOTAL 4 TIMES (EXACT DURATION IS UNKNOWN, INITIAL REPORT INDICATES 5 MINUTES) AND MORE INTENSE/LONGER IN DURATION AS BEFORE USING THE MASK. OVERTIME IT GOT LESS INTENSE AND DURATION SHORTENED. THE CONSUMER STILL HAS A SIMILAR LIGHT SENSITIVITY AS AFTER THE SURGERY AND IN GENERAL AVOIDS DIRECT LIGHT EXPOSURE. THE CONSUMER SOUGHT MEDICAL TREATMENT.

Description of Event or Problem

A FEMALE CONSUMER REPORTED SHE TRIED THE NEUTROGENA VISIBLY CLEAR LIGHT THERAPY ACNE MASK FOR ACNE TREATMENT ON (B)(6) 2018 AND IT DISTURBED HER EYES. SHE USED THE PRODUCT ONCE BUT HAD 4 OCCASIONS WHEN SHE LOST HER VISION FOR APPROXIMATELY 5 MINUTES. CONSUMER HAS REPORTED THAT SHE HAD EYE SURGERY PRIOR TO USING THE MASK ON (B)(6) 2016. THIS WAS A LASER SURGERY TO CORRECT DEFECTIVE VISION. SHE SAID THAT AFTER THAT SURGERY, SHE ALREADY HAD GENERAL LIGHT SENSITIVITY AND A FEW OCCASIONS, WHERE SHE UNREGULARLY LOST VISIONS FOR SHORT TIMES (E.G. ALSO IN BRIGHT SUN LIGHT). THE NEUTROGENA VISIBLY CLEAR LIGHT THERAPY ACNE MASK WAS USED ONLY ONCE ON (B)(6) 2018 WITH CLOSED EYES. AFTERWARDS SHE HAD AGAIN LOSS OF VISION, UNREGULARLY FOR IN TOTAL 4 TIMES (EXACT DURATION IS UNKNOWN, INITIAL REPORT INDICATES 5 MINUTES) AND MORE INTENSE/LONGER IN DURATION AS BEFORE USING THE MASK. OVERTIME IT GOT LESS INTENSE AND DURATION SHORTENED. THE CONSUMER STILL HAS A SIMILAR LIGHT SENSITIVITY AS AFTER THE SURGERY AND IN GENERAL AVOIDS DIRECT LIGHT EXPOSURE. AT THIS TIME, THE CONSUMER HAS NOT SOUGHT MEDICAL ATTENTION.

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. CORRECTION TO B5: UPON CLARIFICATION, AT THIS TIME THE CONSUMER HAS NOT SOUGHT MEDICAL ATTENTION. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

Additional Manufacturer Narrative

DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA (B)(4). A MANUFACTURING INVESTIGATION WAS PERFORMED FOR THE SUBJECT DEVICE. THE DEVICE WAS INSPECTED AND TESTED AND NO DEFECTS WERE NOTED. THE DEVICE FUNCTIONED AS INTENDED, THEREFORE THE COMPLAINT OR PROBLEM CANNOT BE CONFIRMED. AT THIS TIME, NO CONCLUSION IS ABLE TO BE DRAWN. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THIS FOLLOW-UP MEDWATCH, AN ADDITIONAL FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.