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

Model Number	05600
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hyphema (1911); Intraocular Pressure, Delayed, Uncontrolled (1936); Retinal Injury (2048); Optical Tissue, Breakdown Of (2106); Visual Impairment (2138)
Type of Reportable Event	Serious Injury
Event or Problem Description
A male patient (age not reported) having elevated intraocular pressure (iop) of 18mmhg in the left eye and on atropine 1% hypotensive medication was treated with the sight sciences omni surgical system (date not reported).Postop, the patient had a 5% hyphema persisting 1 week and as reported to a sight sciences sales representative presented several months later with decreased vision and retinal folds with a cyclodialysis cleft.The patient was referred to another specialist to surgically repair the cleft that extended from approximately 8:00 to 10:00 position.On (b)(6) 2019 the surgeon repaired the cleft with an endoscopic cyclophotocoagulation laser and multiple iridoplasty.Postprocedure followup occurred on (b)(6) 2020 and the patient had hypotony (iop of 3mmhg) and decreased vision.The cleft was smaller, but reported to be visible at the 10:00 position and the patient was prescribed atropine 1%.The patient's status/prognosis was not reported as of (b)(6) 2020.

• Brand Name: OMNI SURGICAL SYSTEM
• Common Device Name: PUMP, INFUSION, OPHTHALMIC
• Manufacturer (Section D): SIGHT SCIENCES, INC.; 4040 campbell ave.; suite 100; menlo park, ca
• MDR Report Key: 10105287
• Report Number: 3010363671-2020-00001
• Device Sequence Number: 16724110
• Product Code: MRH
• UDI-Device Identifier: 00858027006310
• UDI-Public: (01)00858027006310
• Combination Product (Y/N): N
• 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): 06/01/2020

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 Model Number: 05600
• Device Catalogue Number: 1-100
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2020
• Initial Report FDA Received Date: 06/01/2020
• 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: Required Intervention; Disability
• Patient Age: 50 YR