OMNI Surgical System (US) FG 05600Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00858027006310), received between Jan 16, 2019 and Jun 1, 2020 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJun 1, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A MALE PATIENT (AGE NOT REPORTED) HAVING ELEVATED INTRAOCULAR PRESSURE (IOP) OF 18MMHG IN THE LEFT EYE AND ON ATROPINE 1% HYPOTENSIVE MEDICATION WAS TREATED WITH THE SIGHT SCIENCES OMNI SURGICAL SYSTEM (DATE NOT REPORTED). POSTOP, THE PATIENT HAD A 5% HYPHEMA PERSISTING 1 WEEK AND AS REPORTED TO A SIGHT SCIENCES SALES REPRESENTATIVE PRESENTED SEVERAL MONTHS LATER WITH DECREASED VISION AND RETINAL FOLDS WITH A CYCLODIALYSIS CLEFT . THE PATIENT WAS REFERRED TO ANOTHER SPECIALIST TO SURGICALLY REPAIR THE CLEFT THAT EXTENDED FROM APPROXIMATELY 8:00 TO 10:00 POSITION. ON (B)(6) 2019 THE SURGEON REPAIRED THE CLEFT WITH AN ENDOSCOPIC CYCLOPHOTOCOAGULATION LASER AND MULTIPLE IRIDOPLASTY. POSTPROCEDURE FOLLOWUP OCCURRED ON (B)(6) 2020 AND THE PATIENT HAD HYPOTONY (IOP OF 3MMHG) AND DECREASED VISION. THE CLEFT WAS SMALLER, BUT REPORTED TO BE VISIBLE AT THE 10:00 POSITION AND THE PATIENT WAS PRESCRIBED ATROPINE 1%. THE PATIENT'S STATUS/PROGNOSIS WAS NOT REPORTED AS OF (B)(6) 2020.

  Patient problems: Hyphema; Intraocular Pressure, Delayed, Uncontrolled; Optical Tissue, Breakdown Of; Retinal Injury; Visual Impairment

  MAUDE report 10105287 ↗
• InjuryDec 13, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2019, THE SURGEON PERFORMED VISCODILATION AND GONIOTOMY WITH THE OMNI SURGICAL SYSTEM AS WELL AS CATARACT SURGERY. SURGERY WAS UNEVENTFUL AND THERE WERE NO INTRAOPERATIVE COMPLICATIONS. AT ONE WEEK POST-SURGERY, THE PATIENT HAD HYPOTONY WITHOUT ANY CLINICAL SIGNS AND THE VISUAL ACUITY WAS UNCHANGED FROM PRE-OP (20/50). THE PATIENT WAS PRESCRIBED STEROIDS TO INCREASE THE IOP. THE PATIENT'S PRESSURE CONTINUED TO BE LOW FOR THE FIRST MONTH POST-SURGERY. AT APPROXIMATELY 6 WEEKS POST-SURGERY ((B)(6) 2019), THE IOP INCREASED TO 10 MMHG BUT THE VISUAL ACUITY HAD DECREASED TO 20/400. AT APPROXIMATELY 2 MONTHS POST-SURGERY ((B)(6) 2019), WITH THE PRESSURE STILL LOW AND THE VISION AT 20/200, THE PATIENT WAS SEEN BY A NEURO-OPHTHALMOLOGIST WHO DIAGNOSED THE PATIENT WITH PAPILLEDEMA DUE TO AN EXTENDED PERIOD OF LOW PERFUSION AS A RESULT OF LOW IOP. THE PATIENT IS UNDER TREATMENT AND OBSERVATION. THE OPTIC NERVE SWELLING HAS REDUCED BUT THE VISION IS STILL 20/200. THE DOCTOR IS UNABLE TO DETERMINE THE PATHOPHYSIOLOGY BEHIND THE PAPILLEDEMA.

  Patient problems: Visual Impairment

  MAUDE report 9466903 ↗
• MalfunctionJan 16, 2019Improper or Incorrect Procedure or Method; Detachment of Device or Device Component; No Apparent Adverse Event; Improper or Incorrect Procedure or Method; Detachment of Device or Device Component; No Apparent Adverse Event

  ON (B)(6) 2018, THE SURGEON ADVANCED THE MICROCATHETER OF THE OMNI SURGICAL SYSTEM INTO SCHLEMM'S CANAL. AS HE BEGAN TO RETRACT THE MICROCATHETER, HE OBSERVED THAT IS WAS DETACHED FROM CANNULA AND REMAINED IN THE CANAL. HE GRASPED THE DETACHED PORTION WITH FORCEPS AND COMPLETED THE GONIOTOMY SUPERIORLY. HE THEN USED THE FORCEPS TO THREAD THE MICROCATHETER INTO THE OTHER DIRECTION OF SCHLEMM'S CANAL AND CREATED A GONIOTOMY INFERIORLY. HE THEN REMOVED THE MICROCATHETER FROM THE EYE WITH THE FORCEPS. THERE WERE NO INTRAOPERATIVE OR POST-OPERATIVE COMPLICATIONS ASSOCIATED WITH THIS PRODUCT ISSUE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8254038 ↗