MAUDE Adverse Event Report: Sight Sciences Inc; OMNI Surgical Sysstem

Catalog Number	1-108
Medical Device Problem Codes	Mechanical Problem (1384); Use of Device Problem (1670)
Health Effect - Clinical Codes	Intraocular Pressure Decreased (4468); Unspecified Eye / Vision Problem (4471)
Date of Event	08/17/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
A physician who performed an omni procedure reported that the device wheel became stuck and would not advance.A second device was opened, and the same issue was encountered.On postoperative day 1, the patient's intraocular pressure (iop) was reported to be 2 mmhg.The physician discontinued all iop-lowering medications and suspected that a cyclodialysis cleft may have occurred as a result of the device becoming jammed and potentially springing out.The patient is scheduled for follow-up evaluation, including gonioscopy.

• Common Device Name: OMNI Surgical Sysstem
• Manufacturer (Section D): Sight Sciences Inc; 4040 campbell avenue; suite 100; menlo park CA 94025
• Manufacturer (Section G): Sight Sciences Inc; 4040 campbell ave; suite 100; menlo park CA 94025
• Manufacturer Contact: ranjani madhavan ; 4040 campbell ave; suite 100; menlo park, CA 94025
• MDR Report Key: 50797216
• Report Number: 3010363671-2026-00015
• Device Sequence Number: 9570771
• Product Code: MRH
• UDI-Device Identifier: 00858027006525
• UDI-Public: (01)00858027006525(17)290428(10)F26D28-02
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K202678
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Type of Report: Initial
• Report Date (Section B): 09/16/2026

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 Catalogue Number: 1-108
• Device Lot Number: F26D28-02
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/08/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/17/2026
• Initial Report FDA Received Date: 09/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown