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

Catalog Number	1-108
Medical Device Problem Codes	Retraction Problem (1536); Material Twisted/Bent (2981)
Health Effect - Clinical Codes	Hyphema (1911); Intraocular Pressure Increased (1937)
Date of Event	03/13/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The physician using an omni procedure reported that the catheter kinked during the goniotomy procedure and didn't allow for a smooth retraction like it usually does.There was significant heme at the entry point of the cannula that is suspected to be related to the retraction not being smooth.Day 1 post-op iop was 18 with 0.5mm hyphema.At the 1 week follow up, iop was 14 and the hyphema had cleared up.At the 4 week follow up, iop had spiked to 38mmhg.The patient was prescribed prednisone post op in addition to the latanoprost that the patient was on for the past year including through the surgery and post op.At the 4 week follow up, the patient was advised to stop the steroids and add pilocarpine.Patient's last reported iop measurement was 18mmhg.

• Brand Name: OMNI SURGICAL SYSTEM
• Common Device Name: OMNI SURGICAL SYSTEM
• Manufacturer (Section D): SIGHT SCIENCES INC.,; 4040 campbell avenue,; suite 100; menlo park CA 94025
• Manufacturer (Section G): SIGHT SCIENCES INC.,; 4040 campbell avenue; suite 100; menlo park CA 94025
• Manufacturer Contact: ranjani madhavan ; 4040 campbell avenue; suite 100; menlo park, CA 94025
• MDR Report Key: 19084363
• Report Number: 3010363671-2024-00004
• Device Sequence Number: 8283416
• Product Code: MRH
• UDI-Device Identifier: 00858027006525
• UDI-Public: 00858027006525
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/09/2024

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?: Yes
• Device Catalogue Number: 1-108
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2024
• Initial Report FDA Received Date: 04/10/2024
• 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: Other
• Patient Sex: Unknown