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

Model Number FG 06721

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

Patient Problems Retinal Detachment (2047); Intraocular Pressure Decreased (4468)

Event Date 10/12/2022

Event Type  Injury  

Event Description

Physician performed an uneventful cataract procedure followed by an uneventful viscodilation procedure using an omni device.On day 1 post-op, hyphema and hypotony (intra ocular pressure - 4mmhg) was observed.Hypotony persisted for 2 weeks and the patient was prescribed oral and topical steroids.On day 10 post-op, retinal detachment was reported, an interventional surgery was performed to prevent permanent vision loss.

• Brand Name: OMNI SURGICAL SYSTEM
• Type of Device: OMNI SURGICAL SYSTEM
• Manufacturer (Section D): SIGHT SCIENCES,INC.; 4040, campbell ave; suite 100; menlo park CA 94025
• Manufacturer (Section G): SIGHT SCIENCES,INC.; sight sciences,inc.; 4040 campbell ave, suite 100; menlopark CA 94025
• Manufacturer Contact: ranjani ` madhavan ; 4040 campbell ave; suite 100; menlo park, CA 94025
• MDR Report Key: 15982725
• MDR Text Key: 305492431
• Report Number: 3010363671-2022-00010
• Device Sequence Number: 1
• Product Code: MRH
• UDI-Device Identifier: 00858027006372
• UDI-Public: 00858027006372
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K202678
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: FG 06721
• Device Catalogue Number: 1-102
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/15/2022
• 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