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	08/15/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The surgeon who performed an omni procedure reported that during the canaloplasty procedure in the inferior hemisphere, the catheter got stuck while advancing and broke off in the eye.The broken part that was lodged in the trabecular meshwork was retrieved using micro forceps.The patient had narrow angles, scarred tm and some iris synechiae prior to the omni procedure.Omni is contraindicated for patients with narrow angle glaucoma.There was no further injury associated with the omni procedure.

• 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 ave; suite 100; menlo park, CA 94025
• MDR Report Key: 20211254
• Report Number: 3010363671-2024-00013
• Device Sequence Number: 7745565
• 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): 09/13/2024

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?: No
• Device Catalogue Number: 1-108
• Device Lot Number: F23G24-03
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/16/2024
• Initial Report FDA Received Date: 09/13/2024
• 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