MAUDE Adverse Event Report: SHARKNINJA OPERATING LLC SHARK CRYOGLOW; LIGHT BASED OVER THE COUNTER WRINKLE REDUCTION

Model Number	FW312
Health Effect - Clinical Codes	Conjunctivitis (1784); Corneal Abrasion (1789); Dry Eye(s) (1814); Red Eye(s) (2038); Eye Pain (4467); Hyperresponsive to stimuli (4538); Eye Irritation (4803)
Date of Event	04/16/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Used shark cryoglow led and near infrared treatment mask as directed for 20 sessions in better aging mode and 20 sessions in sustain mode.Eyes became very red, dry, irritated, light sensitive and painful, requiring a visit to urgent care clinic while on vacation.Had stopped using the device a week previously, hoping eye issues would clear spontaneously.Instead, they just got worse.The nurse practitioner prescribed tobrax eyedrops (antibiotic & steroid combo) for conjunctivitis, inflammation and gave me a stat referral to see an ophthalmologist, which i did when i returned to my home, 2 days later, it being a 9-hour drive.I couldn't assist with driving due to the continuing eye issues.The ophthalmologist at (b)(6) hospital in (b)(6) did a thorough exam, including multiple eye tests and dilation of pupils.I was told to discontinue using the mask (which i already had done), continue using antibiotic eye drops and buy lubricating one over-the-counter (otc), return in 2 weeks on may 2.My eyes continue to be very dry, irritated and light sensitive.She said the led light causes heat and my eyes were very dried out.She indicated my left cornea was scratched as well.Medical record available with tests results, if required and requested.

• Brand Name: SHARK CRYOGLOW
• Common Device Name: LIGHT BASED OVER THE COUNTER WRINKLE REDUCTION
• Manufacturer (Section D): SHARKNINJA OPERATING LLC
• MDR Report Key: 21936592
• Report Number: MW5169675
• Device Sequence Number: 12759953
• Product Code: OHS
• Combination Product (Y/N): N
• 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): 04/24/2025

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
• Operator of Device: Lay User/Patient
• Device Model Number: FW312
• Device Catalogue Number: 2335664280
• Device Lot Number: 3643
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/30/2025
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown