OMNI(R) Surgical System (US) FG 06721Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 00858027006372), received between Sep 24, 2020 and Aug 24, 2023 — classified as 15 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (8 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.

Most reported problems

Recent adverse event reports

The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• InjuryAug 24, 2023Material Fragmentation; Material Fragmentation

  THE PHYSICIAN USING AN OMNI DEVICE, REPORTED THAT THE CATHETER BROKE WHILE PERFORMING THE RETRACTING THE DEVICE. THE BROKEN OFF PART OF THE DEVICE WAS REMOVED USING A FORCEPS. THERE WAS HYPHEMA >1MM THAT WAS NOTED.

  Patient problems: Hyphema

  MAUDE report 17620043 ↗
• InjuryJun 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PHYSICIAN WHO PERFORMED AN OMNI PROCEDURE IN COMBINATION WITH CATARACT EXTRACTION REPORTED THAT THE GONIOTOMY PROCEDURE HAD TO BE ABORTED DUE TO IRIDODIALYSIS. POST-OP DAY 1, SHALLOW CHAMBER WAS OBSERVED, CHAMBER WAS STILL SHALLOW AND THERE WAS A 3MM HYPHEMA. THESE CONDITIONS NORMALIZED AND RESOLVED WITHOUT REQUIRING ANY MEDICAL/SURGICAL INTERVENTION BY POST-OP WEEK ONE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Hyphema

  MAUDE report 17231634 ↗
• InjuryMay 25, 2023Material Fragmentation; Material Fragmentation

  THE PHYSICIAN WHO PERFORMED A 360 DEGREE CANALOPLASTY PROCEDURE USING AN OMNI DEVICE, REPORTED THAT THE CATHETER BROKE WHILE ATTEMPTING A 180 DEGREE CANALOPLASTY IN THE SECOND HEMISPHERE. THE BROKEN OFF PART OF THE DEVICE WAS REMOVED USING A MST FORCEPS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17005593 ↗
• MalfunctionMay 19, 2023Material Fragmentation; Material Fragmentation

  THE PHYSICIAN WHO PERFORMED AN OMNI PROCEDURE, REPORTED THAT THERE WAS SOME RESISTANCE FELT WHILE ADVANCING THE DEVICE INTO THE SCHLEMM'S CANAL AND THE CATHETER KINKED AT THE CANNULA. THE BROKEN OFF PART OF THE CATHETER WAS RETRIEVED USING A MICRO FORCEPS FROM THE SCHLEMM'S CANAL. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE WITHOUT FURTHER INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16966274 ↗
• MalfunctionMay 16, 2023Material Fragmentation; Material Fragmentation

  THE PHYSICIAN WHO PERFORMED AN OMNI PROCEDURE, NOTED THAT THE NYLON SUTURE BROKE-OFF FROM THE CANNULA AND THE PROCEDURE WAS COMPLETED WITH A FRESH DEVICE. THERE WAS NO FURTHER INCIDENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16942893 ↗
• MalfunctionMay 2, 2023Material Fragmentation; Material Fragmentation

  PHYSICIAN USING AN OMNI DEVICE REPORTED THAT THE MICROCATHETER PORTION BROKE-OFF WHILE RETRACTING THE DEVICE. THE BROKEN-OFF PART OF THE MICRO-CATHETER WAS RETRIEVED USING A UTRATA FORCEPS WITHOUT FURTHER INCIDENT. SURGEON REPORTED INCREASED CORNEA EDEMA AFTER THE CATHETER REMOVAL WITH UTRATA FORCEPS THAT RESOLVED WITHOUT FURTHER INCIDENT.

  Patient problems: Corneal Edema

  MAUDE report 16856317 ↗
• MalfunctionApr 21, 2023Material Fragmentation; Material Fragmentation

  PHYSICIAN USING AN OMNI DEVICE REPORTED THAT THE MICROCATHETER PORTION BROKE-OFF WHILE RETRACTING THE DEVICE. THE BROKEN-OFF PART OF THE MICRO-CATHETER WAS RETRIEVED USING A MICRO FORCEPS WITHOUT FURTHER INCIDENT. NO FURTHER INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16792014 ↗
• InjuryMar 29, 2023No Apparent Adverse Event; No Apparent Adverse Event

  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.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 16639817 ↗
• InjuryMar 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PHYSICIAN USING AN OMNI DEVICE REPORTED THAT THE MICROCATHETER RELEASED FROM THE HANDPIECE DURING INITIAL DEPLOYMENT. NO INJURY REPORTED AND THE BROKEN PORTION OF THE MICROCATHETER WAS WITHDRAWN USING FORCEPS WITHOUT FURTHER INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16482955 ↗
• InjuryMar 1, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  PHYSICIAN USING AN OMNI DEVICE REPORTED THAT UPON RE-EXTENSION OF THE MICROCATHETER AND PERFORMANCE OF A GONIOTOMY, THE MICROCATHETER KINKED AND BROKE. THE PHYSICIAN BELIEVES THAT THE CATHETER MAY HAVE BEEN KINKED DUE TO PERIPHERAL ANTERIOR SYNECHIA (PAS). THE PHYSICIAN RETRIEVED THE BROKEN PORTION OF THE MICROCATHETER WITH MICROFORCEPS. THE GONIOTOMY WAS REPORTED AS COMPLETED. ON FOLLOW-UP DAY 1 THERE WAS NO OBSERVED HYPHEMA AND THERE WERE NO COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16461274 ↗
• InjuryDec 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PHYSICIAN PERFORMED AN UNEVENTFUL CATARACT PROCEDURE FOLLOWED BY AN UNEVENTFUL VISCODILATION PROCEDURE USING AN OMNI DEVICE. ON DAY 1 POST-OP, HYPHEMA AND HYPOTONY (INTRA OCULAR PRESSURE - 4MMHG) WAS OBSERVED. HYPOTONY PERSISTED FOR 2 WEEKS AND THE PATIENT WAS PRESCRIBED ORAL AND TOPICAL STEROIDS.ON DAY 10 POST-OP, RETINAL DETACHMENT WAS REPORTED, AN INTERVENTIONAL SURGERY WAS PERFORMED TO PREVENT PERMANENT VISION LOSS.

  Patient problems: Intraocular Pressure Decreased; Retinal Detachment

  MAUDE report 15982725 ↗
• MalfunctionDec 8, 2022Material Fragmentation; Improper or Incorrect Procedure or Method; Material Fragmentation; Improper or Incorrect Procedure or Method

  PHYSICIAN USING AN OMNI DEVICE REPORTED THAT THE MICROCATHETER PORTION OF THE DEVICE KINKED AND BROKE DUE TO AN OBSTRUCTION IN THE SCHLEMM'S CANAL. THE BROKEN-OFF PART OF THE MICRO-CATHETER WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH A FRESH OMNI DEVICE. THERE WAS NO OTHER MEDICAL INTERVENTION REQUIRED AS THERE WERE NO FURTHER COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15946820 ↗
• MalfunctionNov 11, 2022Material Fragmentation; Improper or Incorrect Procedure or Method; Material Fragmentation; Improper or Incorrect Procedure or Method

  PHYSICIAN USING AN OMNI DEVICE REPORTED THAT THE MICROCATHETER PORTION OF THE DEVICE KINKED AND BROKE DUE TO AN OBSTRUCTION IN THE SCHLEMM'S CANAL. THE BROKEN-OFF PART OF THE MICRO-CATHETER WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH A FRESH OMNI DEVICE. THERE WAS NO OTHER MEDICAL INTERVENTION REQUIRED AS THERE WERE NO FURTHER COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15781458 ↗
• InjuryJul 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  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.

  Patient problems: Eye Injury

  MAUDE report 15131761 ↗
• InjuryJul 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  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.

  Patient problems: Hyphema; Intraocular Pressure Increased; UGH (Uveitis Glaucoma Hyphema) Syndrome; Uveitis

  MAUDE report 15079469 ↗
• InjuryJun 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PHYSICIAN PERFORMED AN OMNI PROCEDURE AND REPORTED A PATIENT EXPERIENCING TOTAL HYPHEMA AND IOP SPIKE RESULTING IN VISUAL FIELD PROGRESSION.

  Patient problems: Hyphema; Intraocular Pressure Increased; Unspecified Eye / Vision Problem

  MAUDE report 14846674 ↗
• InjuryMay 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT UNDERWENT OMNI PROCEDURE WITH NO SIGNIFICANT FINDINGS POST-OP DAY 1 AND WEEK 1. PATIENT STOPPED STEROID DROPS 3 DAYS PRIOR TO REPORTING EYE PAIN AND HEADACHE. UPON PHYSICIAN FOLLOW-UP, PATIENT PRESENTED WITH HIGH IOP THAT NECESSITATED MEDICAL INTERVENTION AND PHYSICIAN IS CONSIDERING FURTHER SURGICAL INTERVENTION.

  Patient problems: Intraocular Pressure Increased

  MAUDE report 14274465 ↗
• InjuryMar 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REPORTED PERSISTENT ELEVATED IOP AND CONSIDERATION OF SECONDARY INTERVENTION.

  Patient problems: Intraocular Pressure Increased

  MAUDE report 13830913 ↗
• MalfunctionMay 19, 2021Mechanical Problem; Mechanical Problem

  THE PHYSICIAN WAS OPERATING ON THE RIGHT EYE OF A 67 YEAR OLD AFRICAN AMERICAN FEMALE PATIENT USING THE OMNI SURGICAL SYSTEM. HE SUCCESSFULLY COMPLETED THE CANALOPLASTY PORTION IN THE INFERIOR AND SUPERIOR HEMISPHERES OF THE EYE (360 DEGREES TOTAL). THE PHYSICIAN THEN PLACED THE MICROCATHETER OF THE DEVICE INTO THE SCHLEMM'S CANAL TO PERFORM A 180 DEGREE TRABECULOTOMY. WHEN HE FINISHED ABOUT 45 DEGREES OF TRABECULOTOMY, THE "MICROCATHETER DISLODGED AND FELL IN THE ANTERIOR CHAMBER." THE PHYSICIAN USED FORCEPS TO REMOVE THE PORTION OF THE OMNI SURGICAL SYSTEM MICROCATHETER FROM THE PATIENT'S EYE. THE EVENT DID NOT LEAD TO ANY CLINICALLY NOTEWORTHY CONSEQUENCE. THERE WAS NO INJURY TO THE ENDOTHELIUM OR ELSEWHERE IN THE ANTERIOR CHAMBER. ON FOLLOWUP, THE PHYSICIAN REPORTED THAT THE PATIENT IS DOING FINE AND THERE ARE NO ABNORMAL SIGNS OR SYMPTOMS REPORTED AS A RESULT OF THE DISLODGED CATHETER. THE PATIENT IS HEALING FROM THE SURGICAL PROCEDURES AS EXPECTED. THE SLIT LAMP EXAM WAS WITHIN ACCEPTABLE LIMITS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11850140 ↗
• InjuryJan 12, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FEMALE PATIENT HAD A TREATMENT SESSION WITH THE SIGHT SCIENCES TEARCARE SYSTEM ON (B)(6) 2020. THE NEXT DAY, ON (B)(6) 2020 THE PATIENT PRESENTED AT THE TREATING OFFICE WITH SWELLING AND IRRITATION OF HER LEFT AND RIGHT EYELIDS. THE PATIENT WAS PRESCRIBED ADVIL AND TOBRADEX. SHE ALSO PLACED COMPRESSES WITH AN ICE PACK OVER EACH EYE FOR A FEW DAYS FOLLOWING HER OFFICE EXAMINATION. THE PATIENT SENT AN EMAIL TO THE TREATING OFFICE 5 DAYS LATER STATING THAT THE SWELLING AND PAIN HAD REDUCED SIGNIFICANTLY BUT BOTH OF HER EYELIDS STILL HAVE SOME SWELLING, WITH THE LEFT EYELID APPEARING WORSE THAN THE RIGHT. FURTHERMORE, THE PATIENT STATED THAT EVEN THOUGH HER EYES LOOK MOIST, WHEN SHE WAKES UP IN THE MORNING AFTER PUTTING IN THE GEL AT NIGHT LIKE SHE NORMALLY DOES, HER EYES FEEL VERY DRY AND CRUSTY SINCE THE TEARCARE PROCEDURE. SHE IS NOT SURE WHY THIS OCCURS, BUT STATED THAT THE WEATHER HAS BEEN COLDER AND DRIER OUT IN RECENT DAYS.

  Patient problems: Dry Eye(s); Skin Inflammation/ Irritation

  MAUDE report 11154722 ↗
• InjuryDec 12, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2020, THE SURGEON TREATED THE RIGHT EYE OF A (B)(6) YEAR-OLD MALE GLAUCOMA PATIENT WITH THE OMNI SURGICAL SYSTEM (CATALOG NO. 1-102, LOT NO. 1008143). ON (B)(6) 2020 THE SURGEON NOTED A CHOROIDAL DETACHMENT/VITROUS HEMORRHAGE IN THE PATIENT'S TREATED EYE. THE INITIAL SURGERY WITH THE OMNI DEVICE "WENT SMOOTHLY" WITH NO KNOWN ISSUES DURING THE CASE, ACCORDING TO THE SURGEON. THE PATIENT WAS REFERRED TO A RETINA SPECIALIST. IN A FOLLOW-UP DISCUSSION WITH THE SURGEON, THE PATIENT WAS REPORTED TO BE "HAPPY" AND NO FURTHER INTERVENTION WAS REPORTEDLY REQUIRED. THE SURGEON ALSO STATED THAT THE PATIENT'S IOP WAS NOW AT 8MMHG; NO MACULOPATHY; TRACE OF VITREOUS HEMORRHAGE; AND BEST CORRECTED VISUAL ACUITY WAS 20/40. THE PATIENT WAS STILL UNDER "OBSERVATION." THE FOLLOW-UP INFORMATION IS CURRENT AS OF DECEMBER 11, 2020.

  Patient problems: Eye Injury; Vitreous Hemorrhage

  MAUDE report 10996149 ↗
• MalfunctionSep 26, 2020Break; Stretched; Detachment of Device or Device Component; Material Split, Cut or Torn; Break; Stretched; Detachment of Device or Device Component; Material Split, Cut or Torn

  ON (B)(6) 2020, THE SURGEON WAS TREATING THE RIGHT EYE OF A (B)(6) YEAR-OLD FEMALE PATIENT WITH THE OMNI SURGICAL SYSTEM (CATALOG #: 1-102, LOT #: 1008143). UPON COMPLETING A TRABECULOTOMY OF THE SECOND HEMISPHERE OF SCHLEMM'S CANAL, THE MICROCATHETER "DISCONNECTED FROM THE DEVICE" AND WAS FREELY IN THE ANTERIOR CHAMBER OF THE PATIENT'S EYE. THE SURGEON REMOVED THE PIECE OF THE MICROCATHETER WITH FORCEPS. AFTER THE PROCEDURE, THE PATIENT'S CONDITION WAS REPORTED AS "VERY GOOD."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10591094 ↗
• InjurySep 24, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2020, THE SURGEON WAS TREATING THE LEFT EYE OF A FEMALE PATIENT (AGE NOT REPORTED) WITH THE OMNI SURGICAL SYSTEM (CATALOG #1-102, LOT #1008142). UPON REMOVING THE OMNI SURGICAL SYSTEM DEVICE FROM THE PATIENT'S EYE AND IRRIGATING AND ASPIRATING THE TREATED AREA, A LARGE IRIDODIALYSIS WAS OBSERVED THAT REQUIRED REPAIR. THE SURGEON MADE A SCLERAL FLAP AND SUTURED THE IRIS BACK IN PLACE. IT IS NOT KNOWN WHETHER THE OMNI SURGICAL SYSTEM DEVICE CANNULA MADE CONTACT WITH THE IRIS AND CAUSED THE TEAR. MULTIPLE ATTEMPTS HAVE BEEN MADE TO CONTACT THE SURGEON TO COLLECT ADDITIONAL INFORMATION AND PATIENT STATUS WITH NO SUCCESS.

  Patient problems: Eye Injury

  MAUDE report 10584108 ↗