NTG LIGHT THERAPY ACNE MASK

Additional Manufacturer Narrative

DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. PATIENT WEIGHT, ETHNICITY AND RACE WAS NOT PROVIDED FOR REPORTING. BRAND NAME: THIS REPORT IS FOR ONE (1) NTG LIGHT THERAPY ACNE MASK USA 70501101247 7050110124USB 7050110124USB. UPC #: 70501101247 EXP DATE: 20-SEP-2018 LOT #: 2656KS05 UDI #: (B)(4). DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. 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 SEPTEMBER 21, 2016. (B)(4). AT THIS TIME, WITH LIMITED INFORMATION PROVIDED FROM THE CONSUMER, THIS EVENT IS BEING REPORTED WITH AN OVERABUNDANCE OF CAUTION. MACULAR HOLE IS BREAK OR OPENING IN THE MACULA, LOCATED IN THE CENTER OF THE RETINA. THIS COMMONLY AFFECTS PEOPLE OVER THE AGE OF 55 AND MOST OFTEN OCCURS IN WOMEN. IN MOST INSTANCES, THIS DEVELOPS SPONTANEOUSLY WITHOUT AN OBVIOUS CAUSE. SEVERAL CONDITIONS CAN INCREASE THE RISK OF MACULAR HOLE FORMATION. ALTHOUGH THERE IS LIMITED INFORMATION IN THIS CASE, MACULAR HOLE MAY REQUIRE TREATMENT INCLUDING INJECTION OF DRUG INTO THE EYE OR SURGERY TO HELP IMPROVE VISION IF THIS IS DECREASED. DIRECT EXPOSURE OF THE MACULA IS NOT EXPECTED TO HAPPEN WITH USE OF THE NTG LIGHT THERAPY MASK. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE PROVIDED UPON COMPLETION. 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 (B)(6)-YEAR OLD FEMALE CONSUMER REPORTED AN EVENT WITH THE NTG LIGHT THERAPY ACNE MASK. THE CONSUMER HAS USED THE NTG LIGHT THERAPY MASK FOR ACNE ONCE FOR 10 MINUTES IN (B)(6) 2018. THE CONSUMER SOUGHT MEDICAL ATTENTION AND CLAIMED TO HAVE BEEN DIAGNOSED WITH A MACULAR HOLE IN THE LEFT EYE AT AN UNSPECIFIED TIME. THE CONSUMER ALLEGEDLY HAD TO SEE SEVERAL EYE SPECIALISTS BUT DETAILS ON THE DIAGNOSTICS, DIAGNOSIS, TREATMENT AND OUTCOME WERE NOT AVAILABLE.