iStent InfiniteRecalls & reported problems across all models

We found 2 models of iStent Infinite by Glaukos Corporation in the FDA's device registry (GUDID). Together they are named in 59 adverse event reports in the FDA's MAUDE database, received between Sep 28, 2022 and Sep 28, 2026 — classified as 24 injuries, 35 malfunctions.

The most frequently reported specific device problem is “Break” (22 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported iStent Infinite problems

iStent Infinite models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• iStent Infinite iS3

  Implant, Eye Valve
  38 reports
• iStent infinite iS3

  Implant, Eye Valve
  21 reports

Recent iStent Infinite adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50923440 ↗
• MalfunctionSep 23, 2026Break

  Through follow-up, the following additional information was received. Per report, the surgeon confirmed that the trocar was initially observed to be bent while inside the anterior chamber, and was subsequently removed from the eye without being activated. Reportedly, the surgeon touched the bent trocar with forceps outside of the eye, and the trocar then broke with no possibility of any fragment remaining in the eye.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50870021 ↗
• 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 ↗
• MalfunctionMay 11, 2026Malposition of Device

  INITIALLY IT WAS REPORTED THAT DURING ATTEMPT TO IMPLANT THE FIRST STENT FROM A TRABECULAR MICROBYPASS STENT SYSTEM, TWO (2) STENTS (OF THREE (3) STENTS) DEPLOYED SIMULTANEOUSLY. THE REPORT NOTED THAT THE THIRD STENT WAS NOT IMPLANTED. THROUGH FOLLOW-UP, THE FOLLOWING INFORMATION WAS RECEIVED. PER REPORT, THE FIRST STENT WAS IMPLANTED SUCCESSFULLY IN THE PATIENT'S RIGHT EYE (OD), HOWEVER THE SECOND STENT REMAINED IN THE ANTERIOR CHAMBER (AC). REPORTEDLY, THE SURGEON ATTEMPTED TO REMOVE THE SECOND STENT FROM THE (AC), BUT WAS UNSUCCESSFUL. THE REPORT NOTED THAT A BACK-UP DEVICE WAS NOT USED TO IMPLANT ADDITIONAL STENTS, AND THE PATIENT HAS ONE (1) STENT IMPLANTED WITH THE SECOND STENT REMAINING IN THE (AC). THE REPORT ALSO NOTED THAT SURGICAL TECHNIQUE CONTRIBUTED TO THE EVENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 25145008 ↗
• 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 30, 2026Detachment of Device or Device Component

  IT WAS INITIALLY REPORTED THAT DURING ATTEMPT TO IMPLANT THE FIRST STENT FROM A TRABECULAR MICROBYPASS STENT SYSTEM, THE SURGEON NOTICED THAT THE TROCAR APPEARED "BENT", AND THE STENT REMAINED ON THE TROCAR. PER REPORT, THE SURGEON BELIEVED THE TROCAR WAS "DAMAGED" AND USED A SECOND DEVICE TO COMPLETE THE PROCEDURE WITH NO REPORT OF PATIENT INJURY. THROUGH FOLLOW-UP, THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED. PER REPORT, THE SURGEON REPORTED AN UNEVENTFUL PROCEDURE AND REITERATED THAT A NEW DEVICE USED TO COMPLETE THE PROCEDURE. REPORTEDLY, THE SURGEON DOES NOT BELIEVE THERE WERE ANY PREOPERATIVE OR POSTOPERATIVE FACTORS DURING DEVICE HANDLING THAT CONTRIBUTED TO THE EVENT. THE REPORT NOTED THAT THERE WAS NO ADVERSE PATIENT IMPACT OR INTERVENTION REQUIRED AND THE EVENT IS RESOLVED. THE PATIENT STATUS WAS DESCRIBED AS "FINE" AFTER THE NEW DEVICE WAS USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25046387 ↗
• 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 ↗
• InjuryApr 23, 2026Adverse Event Without Identified Device or Use Problem

  INITIALLY IT WAS REPORTED THAT DURING A RIGHT EYE (OD) TRABECULAR MICROBYPASS STENT SYSTEM PROCEDURE, THE SURGEON NOTICED THAT THE TROCAR WAS "BENT" BUT WAS ABLE TO SUCCESSFULLY IMPLANT THREE (3) STENTS. PER REPORT APPROXIMATELY FIVE (5) WEEKS POSTOP, THE PATIENT "DID NOT HAVE A GOOD RECOVERY IN THE CORNEA" AND THE SURGEON REQUESTED A DEVICE EVALUATION. THROUGH FOLLOW-UP, THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED. REPORTEDLY DURING STENT IMPLANTATION, THE GUIDE WIRE BECAME EMBEDDED WITHIN THE CORNEAL STROMA AND BENT AT AN ANGLE, WHICH REQUIRED WITHDRAWING THE INJECTOR AND ATTEMPTING TO "STRAIGHTEN IT" TO ALLOW IMPLANTATION OF THE REMAINING STENTS. PER REPORT, THE EVENT RESULTED IN DECREASED VISION AS COMPARED TO PREOPERATIVE STATE DUE TO EPITHELIAL EDEMA AND "SIGNIFICANT" DECREASE IN ENDOTHELIAL CELL COUNT. THE REPORT NOTED THAT A "NARROW CORNEAL INCISION" CONTRIBUTED TO THE EVENT. PER REPORT, THE PATIENT IS CURRENTLY STABLE WITH IMPROVEMENT IN THE CORNEAL CONDITION, AND THE EVENT RESOLVED WITH SEQUALAE.

  Patient problems: Corneal Edema; Corneal Endothelial Cell Loss; Visual Disturbances

  MAUDE report 24974330 ↗
• 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; Adverse Event Without Identified Device or Use Problem

  THROUGH FOLLOW-UP, THE SURGEON REPORTED THE FOLLOWING ADDITIONAL INFORMATION. PER REPORT, THE DEVICE TIP BROKE DURING THE IMPLANTATION OF THE STENTS IN THE PATIENT'S RIGHT EYE (OD), AND THE STENT WAS NOT ABLE TO BE RELOADED. THE TROCAR FRAGMENT WAS RETRIEVED INTRAOPERATIVELY FROM THE PATIENT'S EYE WITH NO INTERVENTION REQUIRED OR POSTOPERATIVE COMPLICATIONS. THE PATIENT'S CURRENT STATUS WAS DESCRIBED AS "DISCHARGED AND RECOVERED" WITH THE EVENT RESOLVED. THE REPORT NOTED THAT THE PATIENT'S SUDDEN HEAD MOVEMENT DURING IMPLANTATION CONTRIBUTED TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24298843 ↗
• 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 ↗
• MalfunctionJan 12, 2026Break

  THROUGH FOLLOW-UP, THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED FROM THE SURGEON. PER REPORT, DURING THE PATIENT'S LEFT EYE (OS) PROCEDURE "EVERYTHING WAS LOOKING GOOD", BUT "THEN WENT TO PRESS" AND THE TIP BROKE. THE PATIENT'S CURRENT STATUS WAS REPORTED AS INTRAOCULAR PRESSURE (IOP) IS "ON TARGET" AND "GOOD" WITH ONE (1) MEDICATION, AND THE PATIENT STILL BEING MONITORED. THE REPORT NOTED THAT THERE WAS NO ADVERSE PATIENT IMPACT OR INTERVENTION NEEDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24048404 ↗
• 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 ↗

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