MAUDE Adverse Event Report: DRY EYE MASK/WIZARD RESEARCH WIZARD EYE COMPRESS; PAD, HEATING, POWERED

Health Effect - Clinical Codes	Eye Burn (2523); Superficial (First Degree) Burn (2685)
Date of Event	05/08/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Used the wizard eye thermal mask, read the instructions, it gives no temperature guidance at all, set it to 10 on the controller, put on my eyes, after 90 seconds my eye lids were burning.I then checked it with my thermographic camera; it was 145 degrees fahrenheit.That is much too hot for skin or eyes, it actually burned my skin.I then looked up the company and it does not appear to be fda registered, but it is selling a medical device.The company markets this for dry eye and other issues, this product is not safe.Https://www.Wizardresearch.Com/products/heated-eyemask variant=30337129021493&country=us¤cy=usd&utm_medium=product_sync&utm_source=google&utm_content=sag_organic&utm_campaign=sag_organic&gad_source=1&gad_campaignid=20531069984&gclid=cj0kc qjwlyhbbhd9arisalru09qi0g8v2l9s6cy4b4h6hjaxqz6tuhyksn4c-npzjh3xxacjv5avmsqaalavealw_wcb.

• Brand Name: WIZARD EYE COMPRESS
• Common Device Name: PAD, HEATING, POWERED
• Manufacturer (Section D): DRY EYE MASK/WIZARD RESEARCH; 900 wilshire blvd; los angeles CA 90017
• MDR Report Key: 22038653
• Report Number: MW5170499
• Device Sequence Number: 15127111
• Product Code: IRT
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 05/11/2025

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?: Yes
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/16/2025
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 55 YR
• Patient Sex: Male
• Patient Weight: 84 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White