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

Catalog Number	1-112
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/26/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The physician who performed an omni procedure reported that the catheter kindled and broke off while performing goniotomy procedure.The severed portion of the catheter was removed using forceps.
Additional Manufacturer Narrative
The returned device was carefully evaluated and was determined that there is no evidence that the device design or manufacturing process was the cause of the incident.A review of device lot history and analysis of the most suspected components (i.E., cannula and catheter) concluded that there were no production non-conformances or any other anomalies that would have contributed to this event.Engineering had previously recreated the severing of catheter failure which did not point to a design or manufacturing issue as the cause of the failure.The mode of failure does suggest it's associated with a use error.The ifu provides cautionary statements related to possible kinking or damaging (e.G., severing) of microcatheter should the steps not be correctly performed.Therefore, it is concluded that the probable root cause for this event is likely due to a surgical technique or use error.

• Brand Name: OMNI EDGE SURGICAL SYSTEM
• Common Device Name: OMNI EDGE 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 ave; suite 100; menlo park CA 94025
• Manufacturer Contact: ranjani madhavan ; 4040 campbell ave; suite 100; menlo park, CA 94025
• MDR Report Key: 23882134
• Report Number: 3010363671-2025-00018
• Device Sequence Number: 9650409
• Product Code: MRH
• UDI-Device Identifier: 00858027006594
• UDI-Public: (01)00858027006594(17)270530(10)F25E30-01
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K232214
• 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,Followup,Followup,Followup
• Report Date (Section B): 01/16/2025

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: 1-112
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/26/2025
• Supplement Date Received by Manufacturer: Not provided; Not provided; Not provided
• Initial Report FDA Received Date: 12/23/2025
• Supplement Report FDA Received Date: 01/20/2026; 05/05/2026; 05/05/2026
• Was Device Evaluated by Manufacturer? (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