MAUDE Adverse Event Report: SIGHT SCIENCES INC OMNI SURGICAL SYSTEM

Catalog Number	1-108
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/28/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The physician who performed an omni procedure reported that after successful completion of the canaloplasty procedure, the device was met with resistance when the catheter was re-advanced into the schlemm' for the trabeculotomy procedure.The physician unparked the cannula tip and pulled into the middle of the anterior chamber to begin retracting the catheter.It was noted that the device wheel was hard to retract and after 2-3 click backs, the catheter broke off from the cannula.The physician used mst micro forceps to remove the catheter and complete trabeculotomy.

• Brand Name: OMNI SURGICAL SYSTEM
• Common Device Name: OMNI SURGICAL SYSTEM
• Manufacturer (Section D): SIGHT SCIENCES INC; 4040 campbell ave; suite 100; manlo park CA
• 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: 21911326
• Report Number: 3010363671-2025-00005
• Device Sequence Number: 20642466
• Product Code: MRH
• UDI-Device Identifier: 00858027006525
• UDI-Public: (01)00858027006525(17)270911(10)F24J11-02
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 04/25/2025

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: 1-108
• Device Lot Number: F24J11-02
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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