MAUDE Adverse Event Report: SIGHT SCIENCES, INC. TEARCARE SYSTEM; POWERED HEATING PAD

Model Number	5-105
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Dry Eye(s) (1814); Skin Inflammation/ Irritation (4545)
Date of Event	12/04/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
A female patient had a treatment session with the sight sciences tearcare system on (b)(6) 2020.The next day, on (b)(6) 2020 the patient presented at the treating office with swelling and irritation of her left and right eyelids.The patient was prescribed advil and tobradex.She also placed compresses with an ice pack over each eye for a few days following her office examination.The patient sent an email to the treating office 5 days later stating that the swelling and pain had reduced significantly but both of her eyelids still have some swelling, with the left eyelid appearing worse than the right.Furthermore, the patient stated that even though her eyes look moist, when she wakes up in the morning after putting in the gel at night like she normally does, her eyes feel very dry and crusty since the tearcare procedure.She is not sure why this occurs, but stated that the weather has been colder and drier out in recent days.

• Brand Name: TEARCARE SYSTEM
• Common Device Name: POWERED HEATING PAD
• Manufacturer (Section D): SIGHT SCIENCES, INC.; 4040 campbell ave.; suite 100; menlo park CA 94025
• MDR Report Key: 11154722
• Report Number: 3010363671-2021-00001
• Device Sequence Number: 4069317
• Product Code: IRT
• UDI-Device Identifier: 00858027006372
• UDI-Public: 010085802700637217210630101008143
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/12/2021

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: Health Professional
• Device Model Number: 5-105
• Device Catalogue Number: 5-105
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/08/2020
• Initial Report FDA Received Date: 01/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 40 YR