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

Model Number	1-102
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Eye Injury (1845)
Date of Event	08/27/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2020, the surgeon was treating the left eye of a female patient (age not reported) with the omni surgical system (catalog #1-102, lot #1008142).Upon removing the omni surgical system device from the patient's eye and irrigating and aspirating the treated area, a large iridodialysis was observed that required repair.The surgeon made a scleral flap and sutured the iris back in place.It is not known whether the omni surgical system device cannula made contact with the iris and caused the tear.Multiple attempts have been made to contact the surgeon to collect additional information and patient status with no success.

• Brand Name: OMNI SURGICAL SYSTEM
• Common Device Name: OPHTHALMIC INFUSION PUMP
• Manufacturer (Section D): SIGHT SCIENCES, INC.; 4040 campbell ave.; suite 100; menlo park CA 94025
• MDR Report Key: 10584108
• Report Number: 3010363671-2020-00004
• Device Sequence Number: 14147991
• Product Code: MRH
• UDI-Device Identifier: 00858027006372
• UDI-Public: 010085802700637217210630101008142
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K173332
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/24/2020

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 Expiration Date: 06/30/2021
• Device Model Number: 1-102
• Device Catalogue Number: 1-102
• Device Lot Number: 1008142
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2020
• Initial Report FDA Received Date: 09/24/2020
• 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
• Patient Age: 60 YR