OMNI Surgical System FG 07441Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 00858027006525), received between May 9, 2023 and Sep 17, 2026 — classified as 21 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (18 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 25 reports, in the reporter's own words as published by the FDA.

• InjurySep 17, 2026Mechanical Problem; Use of Device Problem

  A physician who performed an OMNI procedure reported that the device wheel became stuck and would not advance. A second device was opened, and the same issue was encountered. On postoperative Day 1, the patient's intraocular pressure (IOP) was reported to be 2 mmHg. The physician discontinued all IOP-lowering medications and suspected that a cyclodialysis cleft may have occurred as a result of the device becoming jammed and potentially springing out. The patient is scheduled for follow-up evaluation, including gonioscopy.

  Patient problems: Intraocular Pressure Decreased; Unspecified Eye / Vision Problem

  MAUDE report 50797216 ↗
• InjuryJul 30, 2025Material Fragmentation; Material Fragmentation

  THE PHYSICIAN WHO PERFORMED AN OMNI PROCEDURE REPORTED THAT THE CATHETER SEVERED WHILE PERFORMING THE 180-DEGREE GONIOTOMY PROCEDURE. THE SEVERED PORTION OF THE CATHETER WAS REMOVED USING FORCEPS. A PARTIAL GONIOTOMY OCCURRED WHILE REMOVING THE SEVERED PORTION OF THE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22668258 ↗
• InjuryJul 10, 2025Material Fragmentation; Material Fragmentation

  THE PHYSICIAN WHO PERFORMED AN OMNI SURGERY REPORTED THAT THE CATHETER BROKE OFF DURING THE EXCISION OF THE TRABECULAR MESHWORK. THE CATHETER WAS REMOVED FROM THE EYE AND THE PROCEDURE WAS COMPLETED USING A NEW DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22472412 ↗
• InjuryMay 22, 2025Material Fragmentation; Material Fragmentation

  THE PHYSICIAN WHO PERFORMED AN OMNI SURGERY REPORTED THAT THE CATHETER BROKE-OFF WHILE RETRACTING THE DEVICE DURING THE TRABECULOTOMY PROCEDURE . THE BROKEN PART OF THE CATHETER WAS REMOVED FROM THE EYE. THERE WAS NO FURTHER INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22074065 ↗
• InjuryApr 25, 2025Material Fragmentation; Material Fragmentation

  THE PHYSICIAN WHO PERFORMED AN OMNI PROCEDURE REPORTED THAT AFTER SUCCESSFUL COMPLETION OF THE CANALOPLASTY PROCEDURE, THE DEVICE WAS MET WITH RESISTANCE WHEN THE CATHETER WAS RE-ADVANCED INTO THE SCHLEMM' FOR THE TRABECULOTOMY PROCEDURE. THE PHYSICIAN UNPARKED THE CANNULA TIP AND PULLED INTO THE MIDDLE OF THE ANTERIOR CHAMBER TO BEGIN RETRACTING THE CATHETER. IT WAS NOTED THAT THE DEVICE WHEEL WAS HARD TO RETRACT AND AFTER 2-3 CLICK BACKS, THE CATHETER BROKE OFF FROM THE CANNULA. THE PHYSICIAN USED MST MICRO FORCEPS TO REMOVE THE CATHETER AND COMPLETE TRABECULOTOMY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21911326 ↗
• InjuryJan 22, 2025Material Fragmentation; Material Fragmentation

  THE PHYSICIAN WHO PERFORMED AN OMNI PROCEDURE REPORTED THAT THE MICROCATHETER KINKED AND BROKE OFF FROM THE DEVICE WHILE ADVANCING IT IN THE SCHLEMM'S CANAL. THE BROKEN PART WAS RETRIEVED USING FORCEPS. THERE WAS NO FURTHER INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21208181 ↗
• InjuryJan 3, 2025Material Fragmentation; Material Fragmentation

  THE PHYSICIAN WHO PERFORMED AN OMNI PROCEDURE REPORTED THAT A KINK IN THE MICROCATHETER WAS NOTED WHILE ADVANCING IN TO THE SCHEMM'S CANAL. WHILE RETRACTING IT BACK TO RELEASE THE KINK, THE MICROCATHETER BROKE OFF. THE BROKEN PART WAS RETRIEVED USING A MST FORCEPS AND THE PROCEDURE WAS COMPLETED USING A FRESH DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21068603 ↗
• InjuryOct 29, 2024Material Fragmentation; Material Fragmentation

  THE PHYSICIAN WHO PERFORMED AN OMNI PROCEDURE REPORTED THAT THE MICROCATHETER BROKE OFF DURING THE PROCEDURE WHILE THE DEVICE WAS IN THE SCHLEMM'S CANAL. THE SURGEON USED A PAIR OF FORCEPS TO RETRIEVE THE PORTION OF THE MICROCATHETER THAT BROKE OFF. THERE WAS NO FURTHER INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20562521 ↗
• MalfunctionOct 28, 2024Unintended Ejection; Unintended Ejection

  DURING AN OMNI PROCEDURE, THE PHYSICIAN PERFORMED A 180-DEGREE CANALOPLASTY IN THE SUPERIOR HEMISPHERE AND UPON RETRACTION, THE MICROCATHETER AUTOMATICALLY ADVANCED FORWARD IN A SPRING LIKE MANNER ABOUT 2MM IN LENGTH. THE ACTION OCCURRED WHILE THE DEVICE WAS STILL IN THE SCHLEMM'S CANAL. THERE WAS NO INJURY REPORTED. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20547012 ↗
• InjurySep 13, 2024Material Fragmentation; Material Fragmentation

  THE SURGEON WHO PERFORMED AN OMNI PROCEDURE REPORTED THAT DURING THE CANALOPLASTY PROCEDURE IN THE INFERIOR HEMISPHERE, THE CATHETER GOT STUCK WHILE ADVANCING AND BROKE OFF IN THE EYE. THE BROKEN PART THAT WAS LODGED IN THE TRABECULAR MESHWORK WAS RETRIEVED USING MICRO FORCEPS. THE PATIENT HAD NARROW ANGLES, SCARRED TM AND SOME IRIS SYNECHIAE PRIOR TO THE OMNI PROCEDURE. OMNI IS CONTRAINDICATED FOR PATIENTS WITH NARROW ANGLE GLAUCOMA. THERE WAS NO FURTHER INJURY ASSOCIATED WITH THE OMNI PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20211254 ↗
• MalfunctionAug 22, 2024Unintended Ejection; Unintended Ejection

  DURING AN OMNI PROCEDURE IT WAS REPORTED THAT THE MICROCATHETER ADVANCED/SHOT FORWARD ON ITS OWN. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY THAT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20027473 ↗
• MalfunctionAug 9, 2024Unintended Ejection; Unintended Ejection

  THE SURGEON WHO PERFORMED AN OMNI PROCEDURE REPORTED THAT THE MICROCATHETER KEPT SPRINGING BACK IN THE CANAL WHILE TRYING TO RETRACT THE DEVICE AFTER COMPLETING THE CANALOPLASTY IN THE FIRST HEMISPHERE. BOTH INDEX FINGERS HAD TO BE USED TO RETRACT AND HOLD THE MICRO CATHETER IN PLACE SO THE DEVICE COULD BE REMOVED WITHOUT INADVERTENTLY TEARING THE TRABECULAR MESHWORK. A NEW DEVICE WAS USED TO COMPLETE THE CANALOPLASTY AND GONIOTOMY PROCEDURE IN THE SECOND HEMISPHERE. THERE WAS NO PATIENT INJURY THAT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19955502 ↗
• MalfunctionJun 14, 2024Material Fragmentation; Material Fragmentation

  THE PHYSICIAN WHO PERFORMED OMNI SURGERY REPORTED THAT THE CATHETER KINKED UPON FEELING RESISTANCE AT ABOUT 90-100 DEGREES DURING THE PROCEDURE. THE CATHETER WAS STUCK WHEN TRYING TO PULL BACK TO REENGAGE. THE CATHETER WAS STUCK AND COULD NOT BE PULLED BACK SO IT WAS PULLED OUT BY DOING A GONIOTOMY. THE DEVICE WAS PULLED OUT OF THE EYE WHILE TRYING TO MOVE THE WHEEL FORWARD OR BACKWARDS AND THE CATHETER BROKE OFF (OUTSIDE THE EYE). THERE WAS NO INTERVENTION REQUIRED AS THE CATHETER BROKE OUTSIDE THE EYE. THE PROCEDURE WAS COMPLETED USING A FRESH DEVICE. AN EVALUATION OF THE RETURNED DEVICE AND A REVIEW OF THE LOT HISTORY AND RELEVANT COMPONENTS OF THE RETURNED DEVICE DETERMINED THAT THERE IS NO EVIDENCE THAT THE DEVICE DESIGN OR MANUFACTURING PROCESS WAS THE CAUSE OF THE INCIDENT. A VIDEO OF THE ACTUAL PROCEDURE WAS NOT AVAILABLE AND THEREFORE A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED; RETURNED DEVICE FOUND TO MEET SPECIFICATION, AND USER HISTORY OF THIS PHYSICIAN AS WELL AS REVIEW OF PAST SIMILAR COMPLAINTS REPORTED BY OTHER PHYSICIANS, WHERE VIDEOS OF THE PROCEDURE WAS PROVIDED THE PROBABLE ROOT CAUSE FOR THIS INCIDENT IS LIKELY DUE TO A SURGICAL TECHNIQUE OR USE ERROR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19542548 ↗
• InjuryApr 29, 2024Material Fragmentation; Material Fragmentation

  THE PHYSICIAN USING AN OMNI DEVICE REPORTED THAT THE CATHETER KINKED ON ADVANCEMENT AND BROKE-OFF IN THE SCHLEMM'S CANAL. THE SEVERED PORTION OF THE MICROCATHETER WAS REMOVED USING FORCEPS. THERE WERE NO FURTHER INJURIES REPORTED. THE PROCEDURE WAS COMPLETED USING A FRESH DEVICE. AN EVALUATION OF THE RETURNED DEVICE AND A REVIEW OF THE LOT HISTORY AND RELEVANT COMPONENTS OF THE RETURNED DEVICE DETERMINED THAT THERE IS NO EVIDENCE THAT THE DEVICE DESIGN OR MANUFACTURING PROCESS WAS THE CAUSE OF THE INCIDENT. A VIDEO OF THE ACTUAL PROCEDURE WAS NOT AVAILABLE AND THEREFORE A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED; HOWEVER, BASED ON: 1) RETURNED DEVICE FOUND TO MEET SPECIFICATION, AND 2) USER HISTORY OF THIS PHYSICIAN AS WELL AS REVIEW OF PAST SIMILAR COMPLAINTS REPORTED BY OTHER PHYSICIANS, WHERE VIDEOS OF THE PROCEDURE WAS PROVIDED THE PROBABLE ROOT CAUSE FOR THIS INCIDENT IS LIKELY DUE TO A SURGICAL TECHNIQUE OR USE ERROR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19209735 ↗
• InjuryApr 10, 2024Retraction Problem; Material Twisted/Bent; Retraction Problem; Material Twisted/Bent

  THE PHYSICIAN USING AN OMNI PROCEDURE REPORTED THAT THE CATHETER KINKED DURING THE GONIOTOMY PROCEDURE AND DIDN'T ALLOW FOR A SMOOTH RETRACTION LIKE IT USUALLY DOES. THERE WAS SIGNIFICANT HEME AT THE ENTRY POINT OF THE CANNULA THAT IS SUSPECTED TO BE RELATED TO THE RETRACTION NOT BEING SMOOTH. DAY 1 POST-OP IOP WAS 18 WITH 0.5MM HYPHEMA. AT THE 1 WEEK FOLLOW UP, IOP WAS 14 AND THE HYPHEMA HAD CLEARED UP. AT THE 4 WEEK FOLLOW UP, IOP HAD SPIKED TO 38MMHG. THE PATIENT WAS PRESCRIBED PREDNISONE POST OP IN ADDITION TO THE LATANOPROST THAT THE PATIENT WAS ON FOR THE PAST YEAR INCLUDING THROUGH THE SURGERY AND POST OP. AT THE 4 WEEK FOLLOW UP, THE PATIENT WAS ADVISED TO STOP THE STEROIDS AND ADD PILOCARPINE. PATIENT'S LAST REPORTED IOP MEASUREMENT WAS 18MMHG.

  Patient problems: Hyphema; Intraocular Pressure Increased

  MAUDE report 19084363 ↗
• InjuryFeb 27, 2024Material Fragmentation; Material Fragmentation

  THE PHYSICIAN USING AN OMNI DEVICE REPORTED THAT THE CATHETER GOT STUCK AND DETACHED WHILE RETRACTING TO PERFORM THE SECOND HALF OF THE 360 DEGREE CANALOPLASTY PROCEDURE. THE DETACHED MICROCATHETER WAS REMOVED USING FORCEPS. THERE WAS NO FURTHER INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18789340 ↗
• InjuryFeb 22, 2024Material Fragmentation; Material Fragmentation

  PHYSICIAN REPORTED CATHETER BREAKING OFF IN THE SCHLEMM'S CANAL DURING TRABECULOTOMY, REQUIRING REMOVAL WITH MICRO FORCEPS. THERE WAS NO FURTHER REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18763322 ↗
• InjuryJan 10, 2024Material Fragmentation; Material Fragmentation

  PHYSICIAN SUCCESSFULLY PERFORMED 180 DEGREE CANALPLASTY UTILIZING AN OMNI DEVICE. UPON SECOND ADVANCEMENT, THE PHYSICIAN REPORTER THE MICROCATHETER BUCKLED AND SNAPPED. THE BROKEN PART OF THE MICROCATHETER WAS REMOVED FROM THE CANAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18490139 ↗
• InjuryNov 27, 2023Material Fragmentation; Material Fragmentation

  THE PHYSICIAN USING AN OMNI DEVICE, REPORTED THAT THE CATHETER SEVERED IN THE EYE DURING PROCEDURE. THE BROKEN PART OF THE MICROCATHETER WAS REMOVED FROM THE CANAL USING A MICRO FORCEPS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18213694 ↗
• InjuryNov 27, 2023Material Fragmentation; Material Fragmentation

  THE PHYSICIAN USING AN OMNI DEVICE, REPORTED THAT THE CATHETER SNAPPED IN THE EYE UNDER NO PRESSURE WHILE PERFORMING THE PROCEDURE .THE SEVERED PART OF THE MICROCATHETER WAS RETRIEVED USING A MICROFORCEPS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18213693 ↗
• InjuryJul 26, 2023Material Fragmentation; Material Fragmentation

  THE PHYSICIAN USING AN OMNI DEVICE, REPORTED THAT THE CATHETER BROKE WHILE PERFORMING THE GONIOTOMY PROCEDURE. THE BROKEN OFF PART OF THE DEVICE WAS REMOVED USING A FORCEPS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17401642 ↗
• InjuryJun 30, 2023Material Fragmentation; Material Fragmentation

  THE PHYSICIAN USING AN OMNI DEVICE, REPORTED THAT THE CATHETER KINKED AND BROKE-OFF WHILE TURNING AND ADVANCING FOR 180 DEGREE GONIOTOMY. THE BROKEN OFF PART OF THE CATHETER WAS RETRIEVED USING A RETINA GRASPING FORCEPS AND THE PROCEDURE WAS COMPLETED WITHOUT FURTHER INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17243356 ↗
• InjuryMay 25, 2023Material Fragmentation; Material Fragmentation

  THE PHYSICIAN USING AN OMNI DEVICE, REPORTED THAT THE CATHETER BROKE-OFF IN THE SCHLEMM'S CANAL WHILE TRYING TO PULL THE DEVICE THROUGH THE TRABECULAR MESHWORK FOR THE GONIOTOMY PROCEDURE. THE BROKEN OFF PART OF THE CATHETER WAS RETRIEVED USING A MST FORCEPS FROM THE SCHLEMM'S CANAL AND THE PROCEDURE WAS COMPLETED WITHOUT FURTHER INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17004870 ↗
• InjuryMay 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WITH SEVERE GLAUCOMA UNDERWENT OMNI PROCEDURE, POST-OP DAY 1 IOP WAS 9MMHG AND WEEK 1 THE IOP WAS 6MMHG. STEROID WAS STOPPED AFTER THE FIRST WEEK. UPON PHYSICIAN FOLLOW-UP AT 2 WEEKS POST-OP, PATIENT PRESENTED WITH HIGH IOP THAT NECESSITATED MEDICAL INTERVENTION AND THE PATIENT'S IOP IS BEING MONITORED ON A WEEKLY BASSIS.

  Patient problems: Intraocular Pressure Increased

  MAUDE report 16911763 ↗
• InjuryMay 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT WHO UNDERWENT A COMBINATION OF OMNI AND CATARACT EXTRACTION PROCEDURE, WAS PRESENTED WITH AN IOP OF 10MMHG DURING WEEK 1 POST-OP. ON DAY 11 POSTOP, THE IOP FURTHER DECREASED TO 3MMHG. THE PHYSICIAN INCREASED THE DOSAGE OF PREDNISONE FROM 4X TO 6X A DAY. AT A SUBSEQUENT FOLLOW UP, IT WAS DETERMINED THAT THE PATIENT HAD A SMALL CLEFT WHICH COULD HAVE INDUCED HYPOTONY IN THE PATIENT'S EYE.

  Patient problems: Intraocular Pressure Decreased

  MAUDE report 16899886 ↗