MAUDE Adverse Event Report: SIGHT SCIENCES INC OMNI SURGICAL SYSTEM

Catalog Number	1-102
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Hyphema (1911)
Date of Event	07/12/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The physician using an omni device, reported that the catheter broke while performing the retracting the device.The broken off part of the device was removed using a forceps.There was hyphema >1mm that was noted.

• 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 ave; suite 100; menlo park CA 94025
• Manufacturer Contact: ranjani madhavan ; 4040 campbell ave; suite 100; menlo park, CA 94025
• MDR Report Key: 17620043
• Report Number: 3010363671-2023-00021
• Device Sequence Number: 7545480
• Product Code: MRH
• UDI-Device Identifier: 00858027006372
• UDI-Public: 00858027006372
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 08/24/2023

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?: Yes
• Device Catalogue Number: 1-102
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/24/2023
• 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: Other
• Patient Sex: Unknown