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

Model Number	05600
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Visual Impairment (2138)
Date of Event	10/17/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
All pertinent information available to sight sciences, inc.Has been submitted.The company is submitting this mdr to ensure full compliance with 21 cfr part 803.Mfr reference #: (b)(4).
Event or Problem Description
On (b)(6) 2019, the surgeon performed viscodilation and goniotomy with the omni surgical system as well as cataract surgery.Surgery was uneventful and there were no intraoperative complications.At one week post-surgery, the patient had hypotony without any clinical signs and the visual acuity was unchanged from pre-op (20/50).The patient was prescribed steroids to increase the iop.The patient's pressure continued to be low for the first month post-surgery.At approximately 6 weeks post-surgery ((b)(6) 2019), the iop increased to 10 mmhg but the visual acuity had decreased to 20/400.At approximately 2 months post-surgery ((b)(6) 2019), with the pressure still low and the vision at 20/200, the patient was seen by a neuro-ophthalmologist who diagnosed the patient with papilledema due to an extended period of low perfusion as a result of low iop.The patient is under treatment and observation.The optic nerve swelling has reduced but the vision is still 20/200.The doctor is unable to determine the pathophysiology behind the papilledema.

• Brand Name: OMNI SURGICAL SYSTEM
• Common Device Name: VISCOELASTIC INJECTOR
• Manufacturer (Section D): SIGHT SCIENCES, INC.; 4040 campbell ave., ste. 100; menlo park CA 94025
• MDR Report Key: 9466903
• Report Number: 3010363671-2019-00002
• Device Sequence Number: 16603027
• Product Code: MRH
• UDI-Device Identifier: 00858027006310
• UDI-Public: (01)00858027006310
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K173332
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/13/2019

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 Model Number: 05600
• Device Catalogue Number: 1-100
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/21/2019
• Initial Report FDA Received Date: 12/13/2019
• 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: 62 YR