MAUDE Adverse Event Report: SIGHT SCIENCES, INC. OMNI SURGICAL SYSTEM; OPHTHALMIC INFUSION PUMP

Model Number	1-102
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Eye Injury (1845); Vitreous Hemorrhage (2143)
Date of Event	10/29/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2020, the surgeon treated the right eye of a (b)(6) year-old male glaucoma patient with the omni surgical system (catalog no.1-102, lot no.1008143).On (b)(6) 2020 the surgeon noted a choroidal detachment/vitrous hemorrhage in the patient's treated eye.The initial surgery with the omni device "went smoothly" with no known issues during the case, according to the surgeon.The patient was referred to a retina specialist.In a follow-up discussion with the surgeon, the patient was reported to be "happy" and no further intervention was reportedly required.The surgeon also stated that the patient's iop was now at 8mmhg; no maculopathy; trace of vitreous hemorrhage; and best corrected visual acuity was 20/40.The patient was still under "observation." the follow-up information is current as of december 11, 2020.

• Brand Name: OMNI SURGICAL SYSTEM
• Common Device Name: OPHTHALMIC INFUSION PUMP
• Manufacturer (Section D): SIGHT SCIENCES, INC.; 4040 campbell ave.; suite 100; menlo park CA 94025
• MDR Report Key: 10996149
• Report Number: 3010363671-2020-00006
• Device Sequence Number: 14576980
• Product Code: MRH
• UDI-Device Identifier: 00858027006372
• UDI-Public: 010085802700637217210630101008143
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K173332
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/11/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2021
• Device Model Number: 1-102
• Device Catalogue Number: 1-102
• Device Lot Number: 1008143
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/11/2020
• Initial Report FDA Received Date: 12/12/2020
• 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 Age: 71 YR