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

Model Number 05600

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

Patient Problem Visual Impairment (2138)

Event Date 10/17/2019

Event Type  Injury  

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 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
• Type of Device: VISCOELASTIC INJECTOR
• Manufacturer (Section D): SIGHT SCIENCES, INC.; 4040 campbell ave., ste. 100; menlo park CA 94025
• Manufacturer (Section G): SIGHT SCIENCES, INC.; 4040 campbell ave., ste. 100; menlo park CA 94025
• Manufacturer Contact: anne-marie ripley ; 4040 campbell ave., ste. 100; menlo park, CA 94025 ; 6616458546
• MDR Report Key: 9466903
• MDR Text Key: 176370992
• Report Number: 3010363671-2019-00002
• 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: 12/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2019
• 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: 11/21/2019
• 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): Other
• Patient Age: 62 YR