iStent Infinite iS3 (REF iS3-US)Recalls & reported problems

Summary

The FDA's MAUDE database contains 38 adverse event reports that list this exact device (DI 00853704002449), received between Feb 1, 2023 and Aug 28, 2026 — classified as 13 injuries, 25 malfunctions.

The most frequently reported specific device problem is “Break” (16 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 38 reports, in the reporter's own words as published by the FDA.

• InjuryAug 28, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that following a right eye (OD) trabecular microbypass stent system procedure in conjunction with an intracameral implant procedure, the patient experienced persistent postoperative inflammation, and a possible metal allergy. Per report, the devices were explanted approximately two and a half (2.5) months postoperatively with no complications.Additional information has been requested.

  Patient problems: Hypersensitivity/Allergic reaction; Inflammation

  MAUDE report 50508306 ↗
• InjuryMay 6, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOLLOWING THE SUCCESSFUL IMPLANTATION OF AN INTRACAMERAL IMPLANT IN THE PATIENT'S LEFT EYE (OS) WITHOUT ISSUE, DURING A SUBSEQUENT ATTEMPT TO IMPLANT THE FIRST STENT FROM A TRABECULAR MICROBYPASS STENT SYSTEM, THE STENT WAS "FREE FLOATING" IN THE EYE. PER REPORT, THE SURGEON REMOVED THE STENT USING FORCEPS AND USED A BACK-UP DEVICE TO COMPLETE THE PROCEDURE WITH "DIFFICULTY" IMPLANTING TWO (2) STENTS DUE TO "POOR" VISUALIZATION. ADDITIONALLY, PER REPORT, DURING IRRIGATION AND ASPIRATION (I/A), A SMALL QUADRANT OF THE IRIS DETACHED WHICH THE SURGEON HAD TO "CLOSE UP". THE REPORT NOTED THAT THE SURGEON IS UNSURE IF THE IRIS DETACHED DURING THE REMOVAL OF THE FREE-FLOATING STENT OR DURING THE SUBSEQUENT IMPLANTATION OF THE STENTS FROM THE BACK-UP DEVICE. THE REPORT ALSO NOTED THAT INTRAOPERATIVE VISIBILITY WAS COMPROMISED DUE TO BLOOD IN THE OPERATIVE EYE. THIS REPORT REFERENCES THE REPORT OF IRIS DAMAGE ASSOCIATED WITH DEVICE ONE (1) OF TWO (2).

  Patient problems: Eye Injury

  MAUDE report 25096453 ↗
• MalfunctionApr 29, 2026Break

  IT WAS REPORTED THAT FOLLOWING A "DIFFICULT" TRABECULAR MICROBYPASS STENT SYSTEM PROCEDURE, THE PATIENT PRESENTED DURING A ONE (1) WEEK POSTOPERATIVE VISIT WITH WHAT WAS DESCRIBED AS A "LONG METALLIC FOREIGN OBJECT" EMBEDDED WHERE THE SECOND STENT WAS IMPLANTED. PER REPORT, THE SURGEON BELIEVES THAT THE TROCAR BROKE OFF, AND A FRAGMENT WAS LEFT EMBEDDED IN THE TRABECULAR MESHWORK (TM). REPORTEDLY, THE SURGEON PLANS TO REMOVE THE FRAGMENT AND ATTEMPT TO RE-IMPLANT THE STENTS. THE REPORT NOTED THAT PATIENT MOVEMENT AND COMPROMISED VISIBILITY CONTRIBUTED TO THE EVENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25037189 ↗
• MalfunctionMar 24, 2026Break

  IT WAS REPORTED THAT DURING ATTEMPT TO IMPLANT THE THIRD STENT FROM A TRABECULAR MICROBYPASS STENT SYSTEM, "A LITTLE PIECE OF METAL" DESCRIBED AS "A LOT LONGER THAN A USUAL STENT" DEPLOYED FROM THE INJECTOR INSTEAD OF A STENT. THE SURGEON REMOVED THE FRAGMENT INTRAOPERATIVELY FROM THE PATIENT'S EYE WITH NO REPORT OF PATIENT INJURY. THE REPORT NOTED THAT THE SECOND STENT WAS ALSO REMOVED INTRAOPERATIVELY, AND THE PATIENT HAS ONE (1) STENT IMPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24677684 ↗
• MalfunctionFeb 9, 2026Break

  IT WAS REPORTED THAT DURING ATTEMPT TO IMPLANT THE STENTS FROM A TRABECULAR MICROBYPASS STENT SYSTEM, THE TROCAR TIP WITH A STENT ON IT BROKE OFF. PER REPORT, THE TROCAR TIP WITH THE STENT WAS REMOVED INTRAOPERATIVELY FROM THE PATIENT'S EYE, AND A BACK-UP DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE WITH NO REPORT OF ADVERSE PATIENT IMPACT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24298822 ↗
• MalfunctionJan 21, 2026Break

  IT WAS REPORTED THAT DURING THE DEPLOYMENT OF THE FIRST STENT FROM A TRABECULAR MICROBYPASS STENT SYSTEM, "A ROD WITH THREE (3) STENTS ATTACHED" BECAME SEPARATED FROM THE INJECTOR. PER REPORT, A BACK-UP DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH NO REPORT OF PATIENT INJURY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24135252 ↗
• InjuryDec 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOLLOWING A LEFT EYE (OS) TRABECULAR MICROBYPASS STENT SYSTEM IN CONJUNCTION WITH AN INTRACAMERAL IMPLANT PROCEDURE, THE PATIENT PRESENTED APPROXIMATELY THREE (3) WEEKS POSTOPERATIVELY WITH A POSSIBLE ALLERGIC REACTION. THROUGH FOLLOW-UP, THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED. THE SURGEON REPORTED AN UNEVENTFUL CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANTATION, AND AN INTRACAMERAL IMPLANT PROCEDURE IN CONJUNCTION WITH A TRABECULAR MICROBYPASS STENT SYSTEM PROCEDURE. PER REPORT, THE PATIENT PRESENTED POSTOPERATIVELY WITH AN ALLERGIC REACTION, LIGHT SENSITIVITY, REDNESS, ASYMPTOMATIC ANTERIOR CHAMBER CELL, AND CONJUNCTIVAL HYPEREMIA, WHICH WAS TREATED WITH A STEROID MEDICATION TAPER. ADDITIONALLY PER REPORT, THE INTRACAMERAL IMPLANT WAS EXPLANTED, AND THE REDNESS, LIGHT SENSITIVITY, AND CONJUNCTIVAL HYPEREMIA RESOLVED WITH THE ANTERIOR CHAMBER CELL "RESOLVING". THE PATIENT'S CURRENT STATUS WAS NOTED AS "DOING WELL" AND "VERY HAPPY" WITH A GOOD PROGNOSIS.

  Patient problems: Hypersensitivity/Allergic reaction; Inflammation; Visual Impairment

  MAUDE report 23784908 ↗
• MalfunctionOct 24, 2025Break; Break

  IT WAS REPORTED THAT FOLLOWING THE SUCCESSFUL IMPLANTATION OF THE FIRST STENT (OF THREE STENTS) FROM A TRABECULAR MICROBYPASS STENT SYSTEM IN THE PATIENT'S RIGHT EYE (OD), THE TROCAR BROKE DURING ATTEMPT TO IMPLANT THE SECOND STENT. PER REPORT, THE FRAGMENTS WERE REMOVED INTRAOPERATIVELY, AND A BACK-UP DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH NO REPORT OF PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23386138 ↗
• MalfunctionAug 21, 2025Break; Break

  IT WAS REPORTED THAT THE TROCAR BROKE DURING A TRABECULAR MICROBYPASS STENT SYSTEM PROCEDURE. PER REPORT, A BACK-UP DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF PATIENT INJURY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22865472 ↗
• MalfunctionAug 6, 2025Break; Break

  IT WAS REPORTED THAT DURING THE IMPLANTATION OF THE FIRST STENT FROM A TRABECULAR MICROBYPASS STENT SYSTEM, WHAT WAS DESCRIBED AS "A METALLIC PIECE" APPEARED TO BREAK OFF OF THE TIP OF THE STENT. PER REPORT, THE SURGEON USED FORCEPS TO REMOVE THE LARGE "FREE FLOATING" STENT FRAGMENT, HOWEVER THE SMALLER FRAGMENT WAS EMBEDDED IN THE IRIS AND WAS UNABLE TO BE RETRIEVED. THE REPORT NOTED THAT THE SURGEON IS UNCLEAR WHETHER IT WAS THE STENT OR THE TROCAR. THERE WAS NO REPORT OF PATIENT INJURY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22729521 ↗
• MalfunctionJul 2, 2025Break; Break

  IT WAS REPORTED THAT THE TROCAR BROKE DURING ATTEMPT TO IMPLANT THE STENTS FROM A TRABECULAR MICROBYPASS STENT SYSTEM. PER REPORT, THE TROCAR FRAGMENTS WERE REMOVED INTRAOPERATIVELY FROM THE PATIENT'S OPERATIVE EYE USING FORCEPS, AND A BACK-UP DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH NO REPORT OF PATIENT INJURY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22384435 ↗
• MalfunctionJul 2, 2025Break; Break

  IT WAS REPORTED THAT THE TROCAR BROKE DURING ATTEMPT TO IMPLANT THE STENTS FROM A TRABECULAR MICROBYPASS STENT SYSTEM. PER REPORT, THE TROCAR FRAGMENTS WERE REMOVED INTRAOPERATIVELY FROM THE PATIENT'S OPERATIVE EYE USING FORCEPS, AND A BACK-UP DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH NO REPORT OF PATIENT INJURY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22384422 ↗
• MalfunctionJan 24, 2025Contamination; Contamination

  IT WAS REPORTED THAT DURING A TRABECULAR MICROBYPASS STENT SYSTEM PROCEDURE, THE SURGEON OBSERVED "BLACK SPOTS" WITHIN THE STERILE PACKAGING OF TWO (2) UNOPENED DEVICES. REPORTEDLY, AN ADDITIONAL DEVICE WAS USED TO COMPLETE THE PROCEDURE. PER REPORT, THE DEVICES WERE UNOPENED/UNUSED, AND THERE WAS NO PATIENT CONTACT. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THIS REPORT REFERENCES THE REPORT OF PARTICULATE/FOREIGN MATTER ASSOCIATED WITH DEVICE TWO (2) OF TWO (2).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21232465 ↗
• MalfunctionJan 24, 2025Contamination; Contamination

  IT WAS REPORTED THAT DURING A TRABECULAR MICROBYPASS STENT SYSTEM PROCEDURE, THE SURGEON OBSERVED "BLACK SPOTS" WITHIN THE STERILE PACKAGING OF TWO (2) UNOPENED DEVICES. REPORTEDLY, AN ADDITIONAL DEVICE WAS USED TO COMPLETE THE PROCEDURE. PER REPORT, THE DEVICES WERE UNOPENED/UNUSED, AND THERE WAS NO PATIENT CONTACT. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THIS REPORT REFERENCES THE REPORT OF PARTICULATE/FOREIGN MATTER ASSOCIATED WITH DEVICE ONE (1) OF TWO (2).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21232448 ↗
• InjuryNov 19, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THROUGH FOLLOW-UP, THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED. PER REPORT, INTRAOPERATIVE COMPLICATIONS WERE DESCRIBED AS "HYPHEMA" AND "POOR VIEW". REPORTEDLY, THERE WAS NO ADVERSE PATIENT IMPACT, AND THE EVENT HAS RESOLVED WITH THE PATIENT "DOING WELL". THE REPORT ALSO NOTED THAT THE PATIENT IS ON BLOOD THINNERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20727624 ↗
• MalfunctionNov 13, 2024Malposition of Device; Malposition of Device

  IT WAS REPORTED THAT DURING A RIGHT EYE (OD) TRABECULAR MICROBYPASS STENT SYSTEM PROCEDURE, THE SURGEON WAS UNABLE TO IMPLANT THE SECOND STENT INTO THE TRABECULAR MESHWORK (TM). PER REPORT, THE SURGEON ATTEMPTED TO REMOVE THE STENT INTRAOPERATIVELY ONTO THE SURGICAL FIELD, HOWEVER THE STENT WAS UNABLE TO BE LOCATED. THERE WAS NO REPORT OF PATIENT INJURY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 20677231 ↗
• MalfunctionSep 27, 2024Break; Break

  IT WAS REPORTED THAT THE TROCAR BROKE DURING ATTEMPT TO IMPLANT THE STENTS FROM A TRABECULAR MICROBYPASS STENT SYSTEM. PER REPORT, NO STENTS WERE IMPLANTED AND "NOTHING WAS LEFT IN THE EYE." ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20326697 ↗
• MalfunctionSep 10, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT FOLLOWING A CATARACT PLUS TRABECULAR MICROBYPASS STENT SYSTEM PROCEDURE, THE PATIENT PRESENTED POSTOP WITH A "FREE FLOATING" STENT. THE SURGEON WAS OFFERED A MEDICAL EXPERT CONSULTATION BUT DID NOT RESPOND. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20185756 ↗
• MalfunctionAug 27, 2024Break; Break

  IT WAS REPORTED THAT FOLLOWING A CATARACT SURGERY, THE SURGEON NOTICED THAT THE TROCAR TIP WAS MISSING DURING ATTEMPT TO IMPLANT THE STENTS FROM A TRABECULAR MICROBYPASS STENT SYSTEM. PER REPORT, A BACK-UP DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF PATIENT INJURY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20077796 ↗
• MalfunctionJul 25, 2024Malposition of Device; Malposition of Device

  IT WAS REPORTED THAT FOLLOWING A LEFT EYE (OS) CATARACT SURGERY, THE FIRST STENT (OF THREE (3) STENTS) FROM A TRABECULAR MICROBYPASS STENT SYSTEM FELL BELOW THE IRIS AND BEHIND THE PSEUDOPHACIC LENS DURING ATTEMPT TO IMPLANT THE STENT. PER REPORT, THE OTHER TWO (2) STENTS WERE SUCCESSFULLY IMPLANTED IN THE TRABECULAR MESHWORK (TM), HOWEVER THE SURGEON WAS UNABLE TO INTRAOPERATIVELY RETRIEVE THE MISPOSITIONED STENT. REPORTEDLY, THE PATIENT IS BEING MONITORED AND IS DOING WELL WITH THE INTRAOCULAR PRESSURE DOWN EIGHT (8) POINTS AS OF POSTOP DAY ONE (1), AND THE MISPOSITIONED STENT ON THE POSTERIOR PART OF THE INTRAOCULAR LENS HAPTIC. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 19829348 ↗
• MalfunctionJul 16, 2024Malposition of Device; Malposition of Device

  IT WAS REPORTED THAT FOLLOWING A CATARACT SURGERY, DURING ATTEMPT TO IMPLANT THE STENTS FROM A TRABECULAR MICROBYPASS STENT SYSTEM, THE SURGEON INADVERTENTLY "LOST TWO (2) STENTS IN THE CHAMBER". A BACK-UP DEVICE WAS USED TO IMPLANT ADDITIONAL STENTS. THE REPORT NOTED THAT PATIENT MOVEMENT CONTRIBUTED TO THE MISPOSITIONED STENTS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 19754907 ↗
• MalfunctionMay 23, 2024Break; Break

  IT WAS REPORTED THAT DURING A TRABECULAR MICROBYPASS STENT SYSTEM PROCEDURE, THE PHYSICIAN OBSERVED THAT THE DEVICE DID NOT HAVE A NEEDLE. THE REPORT NOTED THAT THERE WAS NO PATIENT INJURY AND THAT THE DEVICE WAS DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19385863 ↗
• InjuryMay 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOLLOWING A CATARACT SURGERY, THE SURGEON INADVERTENTLY CREATED A SMALL DESCEMET'S TEAR IN THE ANTERIOR ANGLE DURING THE IMPLANTATION OF A STENT FROM A TRABECULAR MICRO BYPASS STENT SYSTEM IN THE PATIENT'S RIGHT EYE (OD). THE REPORT NOTED THAT COMPROMISED INTRAOPERATIVE VISUALIZATION DUE TO "A LOT OF HEME", PATIENT MOVEMENT, AND PATIENT ANATOMY PRECLUDED IMPLANTATION CONTRIBUTED TO THE REPORTED EVENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Eye Injury

  MAUDE report 19312383 ↗
• InjuryApr 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOLLOWING A RIGHT EYE (OD) CATARACT PLUS TRABECULAR MICROBYPASS STENT SYSTEM PROCEDURE, THE PATIENT PRESENTED ON POSTOP DAY ONE (1) WITH A HYPHEMA ASSOCIATED WITH ELEVATED INTRAOCULAR PRESSURE (IOP). PER REPORT, THE PATIENT WAS BEING MONITORED WITH NO INTERVENTION REQUIRED. THE REPORT ALSO NOTED THAT THE PATIENT WAS ON ANTICOAGULANT THERAPY AND WAS REFERRED TO AN OPHTHALMOLOGIST. THROUGH FOLLOW-UP, THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED. REPORTEDLY, THE PATIENT''S PRESSURE IS "BACK TO NORMAL", AND THE BLEEDING IN THE OPERATIVE EYE HAS RESOLVED.

  Patient problems: Hyphema; Intraocular Pressure Increased

  MAUDE report 19093114 ↗
• MalfunctionJan 31, 2024Malposition of Device; Malposition of Device

  IT WAS REPORTED THAT FOLLOWING A LEFT EYE (OS) CATARACT SURGERY, DURING AN ATTEMPT TO IMPLANT A STENT FROM A TRABECULAR MICROBYPASS STENT SYSTEM, THE STENT WAS OBSERVED "FREE FLOATING" IN THE VITREOUS. REPORTEDLY, THE PROCEDURE WAS COMPLETED USING A BACK-UP DEVICE TO IMPLANT ALL STENTS "PROPERLY AND IN PLACE." PER REPORT, THE SURGEON INITIALLY REQUESTED A MEDICAL CONSULTATION TO DISCUSS TREATMENT OPTIONS FOR THE MISPOSITIONED STENT BUT SUBSEQUENTLY DECLINED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 18616709 ↗