MAUDE Adverse Event Report: SIGHT SCIENCES,INC. OMNI SURGICAL SYSTEM

Model Number	FG 06721
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Retinal Detachment (2047); Intraocular Pressure Decreased (4468)
Date of Event	10/12/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Physician performed an uneventful cataract procedure followed by an uneventful viscodilation procedure using an omni device.On day 1 post-op, hyphema and hypotony (intra ocular pressure - 4mmhg) was observed.Hypotony persisted for 2 weeks and the patient was prescribed oral and topical steroids.On day 10 post-op, retinal detachment was reported, an interventional surgery was performed to prevent permanent vision loss.

• 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.; sight sciences,inc.; 4040 campbell ave, suite 100; menlopark CA 94025
• Manufacturer Contact: ranjani ` madhavan ; 4040 campbell ave; suite 100; menlo park, CA 94025
• MDR Report Key: 15982725
• Report Number: 3010363671-2022-00010
• Device Sequence Number: 5896379
• Product Code: MRH
• UDI-Device Identifier: 00858027006372
• UDI-Public: 00858027006372
• 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): 12/14/2022

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: FG 06721
• Device Catalogue Number: 1-102
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/15/2022
• Initial Report FDA Received Date: 12/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown