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

Model Number 5-105

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

Patient Problems Dry Eye(s) (1814); Skin Inflammation/ Irritation (4545)

Event Date 12/04/2020

Event Type  Injury  

Event 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
• Type of Device: POWERED HEATING PAD
• Manufacturer (Section D): SIGHT SCIENCES, INC.; 4040 campbell ave.; suite 100; menlo park CA 94025
• Manufacturer (Section G): SIGHT SCIENCES, INC.; 4040 campbell ave.; suite 100; menlo park CA 94025
• Manufacturer Contact: edward sinclair ; 4040 campbell ave.; suite 100; menlo park, CA 94025 ; 6502189149
• MDR Report Key: 11154722
• MDR Text Key: 226282803
• Report Number: 3010363671-2021-00001
• Device Sequence Number: 1
• Product Code: IRT
• UDI-Device Identifier: 00858027006372
• UDI-Public: 010085802700637217210630101008143
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: 5-105
• Device Catalogue Number: 5-105
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/08/2020
• Initial Date FDA Received: 01/12/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 40 YR