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

Model Number 1-100

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

Patient Problems Hyphema (1911); Intraocular Pressure, Delayed, Uncontrolled (1936)

Event Date 02/24/2020

Event Type  Injury  

Event Description

A female patient, (b)(6) years of age, with intraocular pressure (iop) of 18 mmhg in the left eye (os) and best corrected visual acuity (bcva) of 20/25 and on several medications (dorzolamide, latanoprost, rhopressa, timolol) was scheduled for surgery on (b)(6) 2020.Surgery was performed on (b)(6) 2020 using the sight sciences' omni surgical system (catalog no.1-100) without complications.The physician placed the omni device into the anterior chamber of the left eye, crossed the trabecular meshwork and advanced the microcatheter to treat the superior hemisphere of schlemm's canal by delivering provisc (sodium hyaluronate) viscoelatic fluid.The microcatheter was retracted and the omni device was removed from the anterior chamber and reinserted to access the inferior hemisphere, delivering the same viscoelastic fluid.The omni microcatheter was advanced a second time in the inferior hemisphere of schlemm's canal and a trabeculotomy was performed.There was no report of trabeculotomy of the superior trabecular meshwork.The patient exhibited hyphema post-operatively that resolved quickly and the iop was reported as "excellent." on (b)(6) 2020 the patient presented with iop of 65 mmhg and emergency surgery was performed.An express shunt was placed in the left eye.At last follow-up, the patient's prognosis was excellent with visual acuity of 20/20 and iop of 6 mmhg.The omni surgical system was not returned to sight sciences for investigation.At the time of receiving the customer complaint, the treating physician's written opinion was that the omni device was not suspected as the potential cause or contributing factor of the iop spike.The physician's opinion of the likely cause of the iop spike was documented as the "trabeculotomy." however, the physican filed a medwatch report a(mw5093771) stating "experienced a possible omni surgical device product failure.".

• 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: 10107292
• MDR Text Key: 195109035
• Report Number: 3010363671-2020-00002
• Device Sequence Number: 1
• Product Code: MRH
• 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: 1-100
• Device Catalogue Number: 1-100
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/28/2020
• 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): Hospitalization; Required Intervention
• Patient Age: 73 YR