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

Model Number	06721
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Eye Injury (1845)
Date of Event	07/05/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Physician performed cataract surgery combined with canaloplasty(omni device) and istent implantation.Uneventful canaloplasty procedure was performed using omni.When re-entering the eye to place the istent, the physician noted a sub-incisional iris root tear abandoned the istent procedure.At post- operative day 1, iop was mildly elevated, no hyphema, and the iris tear was visible.In a follow up visit after a week, the iris was partially in the optical axis and flare was observed in anterior chamber.A repair procedure was performed.At post- operative day 1 after the iris repair, iop was in control.

• Brand Name: OMNI SURGICAL SYETEM
• Common Device Name: OMNI SURGICAL SYETEM
• Manufacturer (Section D): SIGHT SCIENCES,INC.; 4040, campbell ave; suite 100; menlo park CA 94025
• Manufacturer (Section G): SIGHT SCIENCES,INC.; 4040 cambell ave; suite 100; menlo park CA 94025
• Manufacturer Contact: ranjani madhavan ; 4040 campbell ave; suite 100; menlo park, CA 94025
• MDR Report Key: 15131761
• Report Number: 3010363671-2022-00007
• Device Sequence Number: 20275301
• Product Code: MRH
• UDI-Device Identifier: 00858027006372
• UDI-Public: 00858027006372
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K202678
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/29/2022

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
• Device Model Number: 06721
• Device Catalogue Number: 1-102
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/06/2022
• Initial Report FDA Received Date: 07/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR
• Patient Sex: Male