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

Model Number 06721

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

Patient Problems Hyphema (1911); Intraocular Pressure Increased (1937); Uveitis (2122); UGH (Uveitis Glaucoma Hyphema) Syndrome (4470)

Event Type  Injury  

Event Description

Physician performed an uneventful omni procedure in conjunction with cataract surgery.6 months after the original procedure, patient was diagnosed with uveitis by another physician while patient was out of town.Patient was prescribed steroid at that visit for uveitis.The patient was seen by the operating physician one week later.The operating physician placed patient on combigan temporarily while patient completed a steroid taper.The patient returned to the operating physician a month after the diagnosis of uveitis.The patient was no longer on combigan at the visit.~1 mm hyphema with temporal clot was noted.

• Brand Name: OMNI SURGICAL SYSTEN
• Type of Device: OMNI SURGICAL SYSTEN
• Manufacturer (Section D): SIGHT SCIENCES, INC.; 4040 campbell ave; suite 100; menlo park CA 94025
• Manufacturer (Section G): SIGHT SCIENCES,INC.; 4400 campbell ave, suite 100; menlo park CA 94025
• Manufacturer Contact: ranjani madhavan ; sight sciences, inc.; 4040 campbell ave, suite 100; menlo park, CA 94025 ; 7372470998
• MDR Report Key: 15079469
• MDR Text Key: 296346964
• Report Number: 3010363671-2022-00006
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 07/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 06721
• Device Catalogue Number: 1-102
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 79 YR
• Patient Sex: Female