MAUDE Adverse Event Report: SIGHT SCIENCES INC. OMNI SURGICAL SYSTEM

Model Number	1-108
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Intraocular Pressure Increased (1937)
Date of Event	04/12/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient with severe glaucoma underwent omni procedure, post-op day 1 iop was 9mmhg and week 1 the iop was 6mmhg.Steroid was stopped after the first week.Upon physician follow-up at 2 weeks post-op, patient presented with high iop that necessitated medical intervention and the patient's iop is being monitored on a weekly bassis.

• Brand Name: OMNI SURGICAL SYSTEM
• Common Device Name: OMNI SURGICAL SYSTEM
• 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: ranjani madhavan ; 4040 campbell ave; suite 100; menlo park, CA 94025
• MDR Report Key: 16911763
• Report Number: 3010363671-2023-00012
• Device Sequence Number: 6170757
• Product Code: MRH
• UDI-Device Identifier: 00858027006525
• UDI-Public: 00858027006525
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K202678
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/10/2023

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 Model Number: 1-108
• Device Catalogue Number: 1-108
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/12/2023
• Initial Report FDA Received Date: 05/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown