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

Model Number 05600

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hyphema (1911); Intraocular Pressure, Delayed, Uncontrolled (1936); Retinal Injury (2048); Optical Tissue, Breakdown Of (2106); Visual Impairment (2138)

Event Type  Injury  

Event 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
• Type of Device: PUMP, INFUSION, OPHTHALMIC
• Manufacturer (Section D): SIGHT SCIENCES, INC.; 4040 campbell ave.; suite 100; menlo park, ca
• Manufacturer (Section G): SIGHT SCIENCES, INC.; 4040 campbell ave.; suite 100; menlo park, ca
• Manufacturer Contact: edward sinclair ; 4040 campbell ave.; suite 100; menlo park, ca ; 2189149
• MDR Report Key: 10105287
• MDR Text Key: 193287991
• Report Number: 3010363671-2020-00001
• Device Sequence Number: 1
• Product Code: MRH
• UDI-Device Identifier: 00858027006310
• UDI-Public: (01)00858027006310
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K173332
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 05600
• Device Catalogue Number: 1-100
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/27/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Disability
• Patient Age: 50 YR