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	04/22/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The physician who performed an omni surgery reported that the catheter broke-off while retracting the device during the trabeculotomy procedure.The broken part of the catheter was removed from the eye.There was no further injury reported.

• 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 ; suite 100; menlo park, CA 94025
• MDR Report Key: 22074065
• Report Number: 3010363671-2025-00006
• Device Sequence Number: 9362936
• Product Code: MRH
• UDI-Device Identifier: 00858027006525
• UDI-Public: (01)00858027006525(17)270822(10)F24H22-02
• 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): 05/22/2025

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: F24H22-02
• 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: 05/22/2025
• 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