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 Decreased (4468)
Date of Event	04/10/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A patient who underwent a combination of omni and cataract extraction procedure, was presented with an iop of 10mmhg during week 1 post-op.On day 11 postop, the iop further decreased to 3mmhg.The physician increased the dosage of prednisone from 4x to 6x a day.At a subsequent follow up, it was determined that the patient had a small cleft which could have induced hypotony in the patient's eye.

• Brand Name: OMNI SURGICAL SYSTEM
• Common Device Name: OMNI SURGICAL SYSTEM
• Manufacturer (Section D): SIGHT SCIENCES INC.; 4040 campbell ave; suite 100; menlopark CA 94025
• Manufacturer (Section G): SIGHT SCIENCES INC.; 4040 campbell ave`; suite 100; menlo park CA 94025
• Manufacturer Contact: ranjani madhavan ; 4040 campbell avenue; menlo park, CA 94025
• MDR Report Key: 16899886
• Report Number: 3010363671-2023-00011
• Device Sequence Number: 17533170
• Product Code: MRH
• UDI-Device Identifier: 00858027006525
• UDI-Public: 00858027006525
• Combination Product (Y/N): N
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/09/2023

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: 04/10/2023
• Initial Report FDA Received Date: 05/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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: Required Intervention
• Patient Sex: Unknown