MAUDE Adverse Event Report: THE LIGHT SALON BOOST LIMITED BOOST ADVANCED LED LIGHT THERAPY FACE MASK; LIGHT BASED OVER THE COUNTER WRINKLE

Lot Number	10 1019KY
Health Effect - Clinical Codes	Blurred Vision (2137); Loss of Vision (2139)
Date of Event	01/08/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
On 5th use of boost face mask (manufactured by the light salon) suffered transient vision loss / blurred vision of 2 mins in duration with flash burns to eyes.Mask did not come with eye goggles; i had placed a blanket over my eyes (to cover them during mask use) for the cycle.Subsequent f/u with ophthalmologist confirmed flash burns to eyes.Placed on antibiotics.To date, no permanent vision loss appears to have occurred.

• Brand Name: BOOST ADVANCED LED LIGHT THERAPY FACE MASK
• Common Device Name: LIGHT BASED OVER THE COUNTER WRINKLE
• Manufacturer (Section D): THE LIGHT SALON BOOST LIMITED
• MDR Report Key: 9793147
• Report Number: MW5093530
• Device Sequence Number: 15947335
• Product Code: OHS
• Combination Product (Y/N): Y
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 03/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: No Information
• Device Lot Number: 10 1019KY
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/04/2020
• Patient Sequence Number: 1
• Patient Age: 37 YR