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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Blurred Vision (2137); Loss of Vision (2139)

Event Date 01/08/2020

Event Type  Injury  

Event 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
• Type of Device: LIGHT BASED OVER THE COUNTER WRINKLE
• Manufacturer (Section D): THE LIGHT SALON BOOST LIMITED
• MDR Report Key: 9793147
• MDR Text Key: 182515502
• Report Number: MW5093530
• Device Sequence Number: 1
• Product Code: OHS
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 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
• Device Operator: No Information
• Device Lot Number: 10 1019KY
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/04/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 37 YR