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

Model Number	FG 06721
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	02/27/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Physician reported descemet's membrane detachment (meddra code- 10012532) following omni procedure.At one week post-op follow-up with the patient, the physician reported the detachment had spontaneously reattached.The physician reported that the patient suffers from plateau iris syndrome.The event resolved with no impairment and no medical or surgical intervention.

• 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: 16639817
• Report Number: 3010363671-2023-00008
• Device Sequence Number: 6097581
• Product Code: MRH
• UDI-Device Identifier: 00858027006372
• UDI-Public: 00858027006372
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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
• Type of Report: Initial
• Report Date (Section B): 03/29/2023

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: FG 06721
• Device Catalogue Number: 1-102
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2023
• Initial Report FDA Received Date: 03/29/2023
• 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: Other
• Patient Sex: Unknown