MAUDE Adverse Event Report: SIGHT SCIENCES INC OMNI SURGICAL SYSTEM

Model Number	1-108
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/02/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The physician who performed an omni procedure reported that the microcatheter broke off during the procedure while the device was in the schlemm's canal.The surgeon used a pair of forceps to retrieve the portion of the microcatheter that broke off.There was no further injury reported.
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 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 cambell ave; suite 100; menlo park, CA 94025
• MDR Report Key: 20562521
• Report Number: 3010363671-2024-00018
• Device Sequence Number: 7873373
• 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: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/10/2026

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 Model Number: 1-108
• Device Lot Number: F24C05-02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/02/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/29/2024
• Supplement Report FDA Received Date: 03/10/2026
• 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