VISCO(TM)360 Viscosurgical System FG 03916Recalls & reported problems
Sight Sciences, Inc. · US version of the Visco360 · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Sight Sciences Visco360 system is a microcatheter device used to deliver viscous fluid inside the eye during glaucoma surgery. There are 23 reports naming its identifier, and most describe the microcatheter kinking or being severed during the procedure, in one case leaving a piece that had to be retrieved from inside the eye. The reports mention no deaths and 1 injury. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 23
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 00858027006013), received between Feb 20, 2017 and Oct 25, 2017 — classified as 1 injury, 22 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (13 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
Device problems
- Detachment of Device or Device Component13
- Detachment Of Device Component8
- Adverse Event Without Identified Device or Use Problem2
- Use of Device Problem2
- Improper or Incorrect Procedure or Method1
- Material Fragmentation1
Patient problems
- No Known Impact Or Consequence To Patient18
- No Consequences Or Impact To Patient2
- Device Embedded In Tissue or Plaque1
- Eye Injury1
- Hyphema1
- Hypopyon1
- Inflammation1
- Visual Impairment1
Recent adverse event reports
The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 25, 2017Detachment Of Device Component; Detachment Of Device Component
THE SURGEON REPORTED THAT THE MICROCATHETER WAS SEVERED DURING THE PROCEDURE. THE SITE DID NOT REPORT ANY ADVERSE IMPACT TO THE PATIENT ASSOCIATED WITH THIS EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6978150 ↗MalfunctionOct 25, 2017Detachment Of Device Component; Detachment Of Device Component
THE SURGEON REPORTED THAT THE MICROCATHETER WAS SEVERED DURING THE PROCEDURE. THE SITE DID NOT REPORT ANY ADVERSE IMPACT TO THE PATIENT ASSOCIATED WITH THIS EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6978143 ↗MalfunctionJun 29, 2017Detachment Of Device Component; Detachment Of Device Component
DURING SURGERY ON (B)(6)2017, THE MICROCATHETER WAS SEVERED. THE SEVERED PORTION OF THE MICROCATHETER HAD TO BE MANUALLY RETRIEVED FROM SCHLEMM'S CANAL, DURING WHICH A SMALL IRIS DEFECT (APPROXIMATELY 1 CLOCK HOUR) WAS CREATED. ON A POST-OPERATIVE VISIT ON(B)(6)2017, HYPHEMA WAS OBSERVED. ON (B)(6)2017, HYPHEMA WAS STILL PRESENT, BUT MOSTLY CLEARED. DUE TO THE HYPHEMA, THE SURGEON COULD NOT DETERMINE WHETHER THERE WERE ANY ADVERSE SEQUELAE ASSOCIATED WITH THE IRIS DEFECT.
Patient problems: Eye Injury; Hyphema
MAUDE report 6679764 ↗MalfunctionJun 28, 2017Detachment Of Device Component; Detachment Of Device Component
THE SURGEON REPORTED THAT THE MICROCATHETER WAS SEVERED DURING THE PROCEDURE. THE SITE DID NOT REPORT ANY ADVERSE IMPACT TO THE PATIENT ASSOCIATED WITH THIS EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6676047 ↗MalfunctionJun 28, 2017Detachment Of Device Component; Detachment Of Device Component
THE SURGEON REPORTED THAT THE MICROCATHETER WAS SEVERED DURING THE PROCEDURE. THE SITE DID NOT REPORT ANY ADVERSE IMPACT TO THE PATIENT ASSOCIATED WITH THIS EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6675705 ↗MalfunctionJun 28, 2017Detachment Of Device Component; Detachment Of Device Component
THE SURGEON REPORTED THAT THE MICROCATHETER WAS SEVERED DURING THE PROCEDURE. THE SITE DID NOT REPORT ANY ADVERSE IMPACT TO THE PATIENT ASSOCIATED WITH THIS EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6675603 ↗MalfunctionJun 28, 2017Detachment Of Device Component; Detachment Of Device Component
THE SURGEON REPORTED THAT THE MICROCATHETER WAS SEVERED DURING THE PROCEDURE. THE SITE DID NOT REPORT ANY ADVERSE IMPACT TO THE PATIENT ASSOCIATED WITH THIS EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6675470 ↗MalfunctionMay 23, 2017Detachment of Device or Device Component; Detachment of Device or Device Component
THE SURGEON REPORTED KINKING AND SEVERING OF THE MICROCATHETER WHILE PERFORMING VISCODILATION. THE ENTIRE DEVICE WAS REMOVED FROM THE EYE. AT THIS TIME, THERE IS NO KNOWN ADVERSE IMPACT TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6585995 ↗MalfunctionMay 3, 2017Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem
THE SITE REPORTED THAT THE MICROCATHETER WAS SEVERED WHILE PERFORMING VISCODILATION. THE ENTIRE DEVICE WAS REMOVED FROM THE EYE. THERE IS NO KNOWN ADVERSE IMPACT TO THE PATIENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6540083 ↗MalfunctionMay 3, 2017Detachment of Device or Device Component; Detachment of Device or Device Component
THE SITE REPORTED THAT THE MICROCATHETER WAS SEVERED WHILE PERFORMING VISCODILATION. THE ENTIRE DEVICE WAS REMOVED FROM THE EYE. THERE IS NO KNOWN ADVERSE IMPACT TO THE PATIENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6540080 ↗MalfunctionApr 4, 2017Detachment Of Device Component; Detachment Of Device Component
THE SITE REPORTED THAT THE MICROCATHETER WAS SEVERED WHILE PERFORMING VISCO-DILATION. THE ENTIRE DEVICE WAS REMOVED FROM THE EYE. AT THIS TIME THERE IS NO KNOWN ADVERSE IMPACT TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6456556 ↗MalfunctionMar 28, 2017Improper or Incorrect Procedure or Method; Detachment of Device or Device Component; Improper or Incorrect Procedure or Method; Detachment of Device or Device Component
AFTER UNEVENTFUL CANNULATION OF SCHLEMM'S CANAL, DURING RETRACTION OF THE MICROCATHETER THE SURGEON INADVERTENTLY ROTATED THE CANNULA AROUND THE LONGITUDINAL AXIS OF THE MICROCATHETER, THEREBY CAUSING THE CATHETER TO INTERACT WITH THE SHARPENED TIP OF THE CANNULA. AS A RESULT, THE CATHETER WAS SEVERED. THE ENTIRE DEVICE WAS SUCCESSFULLY REMOVED FROM THE EYE THROUGH THE ORIGINAL INCISION. AT THIS TIME THERE IS NO KNOWN ADVERSE IMPACT TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6440653 ↗MalfunctionMar 28, 2017Detachment of Device or Device Component; Detachment of Device or Device Component
THE SURGEON REPORTS KINKING AND SEVERING THE MICROCATHETER WHILE PERFORMING VASODILATION. THE ENTIRE DEVICE WAS REMOVED FROM THE EYE. AT THIS TIME, THERE IS NO KNOWN ADVERSE IMPACT TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6440027 ↗MalfunctionMar 28, 2017Detachment of Device or Device Component; Detachment of Device or Device Component
THE SURGEON REPORTED THAT THE TIP OF THE MICROCATHETER WAS SEVERED WHILE PERFORMING VISCO-DILATION. THE MICROCATHETER SEPARATED FROM THE DEVICE WHEN RETRACTING IT FROM SCHLEMM'S CANAL. THE ENTIRE DEVICE WAS REMOVED SUCCESSFULLY FROM THE EYE. A NEW DEVICE WAS SUCCESSFULLY USED TO COMPLETE THE CASE. THE EVENT DID NOT RESULT IN ANY ADVERSE IMPACT TO THE PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6439938 ↗MalfunctionMar 28, 2017Use of Device Problem; Detachment of Device or Device Component; Use of Device Problem; Detachment of Device or Device Component
THE SURGEON REPORTED THAT THE TIP OF THE MICROCATHETER WAS SEVERED WHILE PERFORMING VISCODILATION OF THE RIGHT EYE. THE MICROCATHETER SEPARATED FROM THE DEVICE WHEN RETRACTING IT FROM SCHLEMM'S CANAL. THE ENTIRE DEVICE WAS REMOVED SUCCESSFULLY FROM THE EYE. A NEW DEVICE WAS SUCCESSFULLY USED TO COMPLETE THE CASE. THE EVENT DID NOT RESULT IN ANY ADVERSE IMPACT TO THE PATIENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6439673 ↗MalfunctionMar 28, 2017Detachment of Device or Device Component; Detachment of Device or Device Component
THE SURGEON REPORTED THAT THE TIP OF THE MICROCATHETER WAS SEVERED DURING USE. THE SEVERED PORTION OF THE DEVICE WAS REMOVED FROM THE EYE WITHOUT INCIDENT. A NEW DEVICE WAS USED TO COMPLETE THE CASE. THE SURGEON REPORTED THERE WERE NO INTRA-OPERATIVE OR POST-OPERATIVE ADVERSE EVENTS ASSOCIATED WITH THIS DEVICE ISSUE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6439506 ↗MalfunctionMar 28, 2017Detachment of Device or Device Component; Detachment of Device or Device Component
THE SURGEON REPORTS SEVERING THE MICROCATHETER WHILE PERFORMING VISCODILATION. THE MICROCATHETER SEPARATED FROM THE DEVICE WHEN RETRACTING IT FROM SCHLEMM'S CANAL. THE ENTIRE DEVICE WAS REMOVED SUCCESSFULLY FROM THE EYE. AT THIS TIME THERE IS NO KNOWN ADVERSE IMPACT TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6438996 ↗MalfunctionMar 28, 2017Detachment of Device or Device Component; Detachment of Device or Device Component
THE SURGEON REPORTS SEVERING THE MICROCATHETER WHILE PERFORMING VISCODILATION OF THE RIGHT EYE. THE MICROCATHETER SEPARATED FROM THE DEVICE WHEN RETRACTING IT FROM SCHLEMM'S CANAL. THE ENTIRE DEVICE WAS REMOVED SUCCESSFULLY FROM THE EYE USING THE ORIGINAL INCISION. THE SITE REPORTED THE PATIENT WAS UNHARMED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6438878 ↗MalfunctionMar 27, 2017Detachment of Device or Device Component; Detachment of Device or Device Component
THE SURGEON REPORTS SEVERING THE MICROCATHETER WHILE PERFORMING VISCODILATION. THE MICROCATHETER SEPARATED FROM THE DEVICE WHEN RETRACTING IT FROM SCHLEMM'S CANAL. THE ENTIRE DEVICE WAS REMOVED SUCCESSFULLY FROM THE EYE USING THE ORIGINAL INCISION. AT THIS TIME THERE IS NO KNOWN ADVERSE IMPACT TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6437905 ↗MalfunctionMar 27, 2017Use of Device Problem; Detachment of Device or Device Component; Use of Device Problem; Detachment of Device or Device Component
THE SURGEON REPORTS KINKING AND THEN SEVERING THE MICROCATHETER WHILE PERFORMING VISCODILATION USING THE VISCO360 DEVICE. THE MICROCATHETER SEPARATED FROM THE DEVICE WHEN RETRACTING IT FROM SCHLEMM'S CANAL. THE ENTIRE DEVICE WAS REMOVED SUCCESSFULLY FROM THE EYE USING THE ORIGINAL INCISION. AT THIS TIME THERE IS NO KNOWN ADVERSE IMPACT TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6437695 ↗MalfunctionMar 27, 2017Detachment of Device or Device Component; Detachment of Device or Device Component
THE SURGEON REPORTS SEVERING THE MICROCATHETER WHILE PERFORMING VISCODILATION. IT WAS REPORTED THAT THE MICROCATHETER SEPARATED FROM THE DEVICE DURING ADVANCEMENT AFTER THE SURGEON MET AN OBSTRUCTION IN SCHLEMM'S CANAL. THE ENTIRE DEVICE WAS REMOVED SUCCESSFULLY FROM THE EYE USING THE ORIGINAL INCISION. AT THIS TIME, THERE IS NO KNOWN ADVERSE IMPACT TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6437220 ↗MalfunctionMar 24, 2017Material Fragmentation; Material Fragmentation
THE VISCO360 DEVICE WAS USED ON (B)(6) 2017 TO PERFORM VISCODILATION OF SCHLEMM'S CANAL ON THE RIGHT EYE. AFTER FULLY RETRACTING THE CATHETER FROM THE FIRST 180 DEGREES OF DILATION OF SCHLEMM'S CANAL, THE SURGEON NOTICED A VERY SMALL BLUE FRAGMENT ENTANGLED IN THE IRIS (PRESUMABLY FROM THE MICROCATHETER). THE SURGEON WAS ABLE TO COMPLETE THE PROCEDURE AND VISCODILATE THE REMAINING 180 DEGREES OF THE CANAL, BUT ELECTED TO LEAVE THE FRAGMENT IN THE IRIS DUE TO CONCERNS ABOUT POTENTIAL COMPLICATIONS INVOLVED IN ITS REMOVAL. ON (B)(6) 2017 SURGEON REPORTED THE PATIENT'S POST-OPERATIVE IOP WAS 8 MMHG WITH SOME HYPHEMA. ON (B)(6) 2017, THE SURGEON REPORTED THAT THE PATIENT WAS HEALING WELL WITH AN IOP OF 11 MMHG (UNMEDICATED). HE WAS ABLE TO VIEW THE FRAGMENT UNDER HIGH MAGNIFICATION AND ESTIMATED IT WAS 10-20 MICRONS. THE FRAGMENT WAS OBSERVED IN THE SAME AREA WHERE THE TRABECULAR MESHWORK WAS ACCESSED TO PERFORM VISCODILATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 6431427 ↗InjuryFeb 20, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ON (B)(6) 2017, THE PATIENT HAD UNEVENTFUL CATARACT SURGERY FOLLOWED BY VASODILATION OF SCHLEMM'S CANAL IN THE LEFT EYE. TWO DAYS POSTOPERATIVELY THE PATIENT WAS DIAGNOSED WITH TASS WITH ASSOCIATED ANTERIOR CHAMBER INFLAMMATION, HYPOPYON, INCREASED WHITE BLOOD CELLS IN THE ANTERIOR CHAMBER, AND DECREASED VISUAL ACUITY. PREOPERATIVELY, THE PATIENT'S BEST CORRECTED VISUAL ACUITY (BCVA) WAS 20/40; AT ONSET, BCVA DECREASED TO 20/100 AND IOP WAS MEASURED AT 14 MMHG. THE PATIENT WAS TREATED WITH TOPICAL STEROIDS, TOPICAL ANTIBIOTICS, AND AN INTRAVITREAL INJECTION. THE EYE WAS CULTURED AND RESULTS WERE NEGATIVE FOR BACTERIA AND FUNGUS. ON FEBRUARY 16, 2017, THE DOCTOR REPORTED THAT THE PATIENT WAS FULLY RECOVERED WITH AN UNCORRECTED VISUAL ACUITY OF 20/50 AND A PINHOLE ACUITY OF 20/30. THERE HAVE BEEN NO OTHER REPORTS OF TASS AT THIS SURGICAL FACILITY AND THE ASSOCIATION BETWEEN THE EVENT AND THE DEVICE IS UNKNOWN.
Patient problems: Hypopyon; Inflammation; Visual Impairment
MAUDE report 6343187 ↗
Other Pump, Infusion, Ophthalmic devices
- OMNI Surgical System FG 07441Sight Sciences, Inc. · Pump, Infusion, Ophthalmic25 reports
- VIA360 Surgical SystemNew World Medical, Incorporated · Pump, infusion, ophthalmic3 reports
- OMNI Edge Surgical System 1-112Sight Sciences, Inc. · Pump, Infusion, Ophthalmic2 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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