OMNI Edge Surgical System 1-112Recalls & reported problems
Sight Sciences, Inc. · OMNI Edge Surgical System · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00858027006594), received between Dec 23, 2025 and Mar 24, 2026 — classified as 2 injuries.
The most frequently reported specific device problem is “Material Fragmentation” (2 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Material Fragmentation2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMar 24, 2026Material Fragmentation
THE PHYSICIAN WHO PERFORMED AN OMNI SURGERY REPORTED THAT THE CATHETER DETACHED FROM THE CANNULA ENTIRELY. THE CATHETER WAS REMOVED FROM THE EYE USING FORCEPS AND THE PROCEDURE WAS COMPLETED. NO PATIENT INJURY HAD BEEN REPORTED AND NO OTHER DEVICE WAS USED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24677794 ↗InjuryDec 23, 2025Material Fragmentation; Material Fragmentation
THE PHYSICIAN WHO PERFORMED AN OMNI PROCEDURE REPORTED THAT THE CATHETER KINDLED AND BROKE OFF WHILE PERFORMING GONIOTOMY PROCEDURE. THE SEVERED PORTION OF THE CATHETER WAS REMOVED USING FORCEPS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23882134 ↗
Other Pump, Infusion, Ophthalmic devices
- OMNI Surgical System FG 07441Sight Sciences, Inc. · Pump, Infusion, Ophthalmic25 reports
- VISCO(TM)360 Viscosurgical System FG 03916Sight Sciences, Inc. · Pump, Infusion, Ophthalmic23 reports
- VIA360 Surgical SystemNew World Medical, Incorporated · Pump, infusion, ophthalmic3 reports
- Streamline Surgical System 10-0066New World Medical, Incorporated · Pump, infusion, ophthalmic1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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