iStent inject W Trabecular Micro-Bypass System with Infinite Injector Technology iS2Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00853704002487), received between May 8, 2025 and Apr 27, 2026 — classified as 5 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 16, 2026.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 27, 2026Break

  IT WAS REPORTED THAT THE TROCAR BROKE DURING THE DEPLOYMENT OF THE FIRST STENT (OF TWO STENTS) FROM A TRABECULAR MICROBYPASS STENT SYSTEM. PER REPORT, THE FRAGMENT WAS REMOVED INTRAOPERATIVELY, AND A BACK-UP DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH NO ADVERSE PATIENT IMPACT. THE REPORT NOTED THAT EYE MOVEMENT AND TROCAR BIAS CONTRIBUTED TO THE EVENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25010499 ↗
• MalfunctionApr 23, 2026Break

  IT WAS REPORTED THAT FOLLOWING THE SUCCESSFUL IMPLANTATION OF THE FIRST STENT AND SUBSEQUENT DEPLOYMENT OF THE SECOND STENT FROM A TRABECULAR MICROBYPASS STENT SYSTEM, "A STENT AND A METAL FRAGMENT" WERE OBSERVED INSIDE THE PATIENT'S RIGHT EYE (OD). PER REPORT, THE SECOND STENT AND THE FRAGMENT WERE REMOVED INTRAOPERATIVELY WITH NO REPORT OF INJURY, AND A BACK-UP DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE REPORT NOTED THAT AFTER THE FIRST STENT WAS IMPLANTED, A STENT WAS PLACED AT THE TIP OF THE "FRACTURED TROCAR" WHICH BECAME LODGED BETWEEN THE TUBE AND THE TROCAR, AND THE SURGEON BELIEVES THE TROCAR BROKE DUE TO PRESSURE APPLIED DURING DEPLOYMENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24973584 ↗
• MalfunctionMar 16, 2026Break

  THROUGH FOLLOW-UP, THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED. PER REPORT, THE SURGEON BELIEVES THAT THE INSERTION TUBE FIRMLY PRESSED AGAINST THE TRABECULAR MESHWORK (TM) RESULTED IN A BENT TROCAR WHILE THE DELIVERY BUTTON WAS PRESSED, AND CONTRIBUTED TO THE EVENT. THERE WAS NO ADVERSE PATIENT IMPACT, NO POSTOPERATIVE INTERVENTION REQUIRED, AND THE PATIENT IS REPORTEDLY STABLE AND DOING WELL WITH THE EVENT RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24612329 ↗
• MalfunctionNov 14, 2025Break; Break

  THROUGH FOLLOW-UP, THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED. PER REPORT, THE SURGEON BELIEVES THAT STRESS ON THE TROCAR DURING THE PROCEDURE CONTRIBUTED TO THE EVENT. REPORTEDLY, THERE WAS NO ADVERSE PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23562790 ↗
• MalfunctionOct 24, 2025Break; Break

  IT WAS REPORTED THAT DURING ATTEMPT TO IMPLANT THE FIRST STENT OF TWO (2) STENTS FROM A TRABECULAR MICROBYPASS STENT SYSTEM, THE TROCAR "CAME OUT FROM THE INSERTION TUBE". PER REPORT, THE SURGEON INITIALLY THOUGHT THAT THE STENT WAS SUCCESSFULLY IMPLANTED WITH THE FIRST DEPLOYMENT, HOWEVER WHEN THE INJECTOR WAS REMOVED FROM THE TRABECULAR MESHWORK (TM), BOTH THE TROCAR AND INSERTION TUBE REMAINED IN THE (TM). PER REPORT, THE SURGEON WAS ABLE TO INTRAOPERATIVELY REMOVE THE TROCAR AND THE TWO (2) STENTS IN THE TROCAR TIP, WITH NO ADVERSE PATIENT IMPACT AND MINIMAL BLEEDING. THE REPORT NOTED THAT THE PROCEDURE WAS COMPLETED USING A BACK-UP DEVICE, WITH TWO STENTS SUCCESSFULLY IMPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23385281 ↗
• InjurySep 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOLLOWING AN UNEVENTFUL RIGHT EYE (OD) CATARACT PLUS TRABECULAR MICROBYPASS STENT SYSTEM PROCEDURE, THE PATIENT PRESENTED ON POSTOPERATIVE DAY ONE (1) WITH FIBRIN FORMATION AND PAIN. PER REPORT, AN ANTERIOR CHAMBER WASHOUT WAS PERFORMED THE SAME DAY, AND THE ANTERIOR CHAMBER APPEARED CLEAR THAT EVENING. REPORTEDLY, THE FOLLOWING MORNING FIBRIN WAS AGAIN OBSERVED, WHICH WAS TREATED WITH MEDICATION AND RESOLVED THE SAME DAY. THROUGH FOLLOW-UP, THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED. PER REPORT, A CULTURE TEST WAS PERFORMED WHICH WAS NEGATIVE FOR BACTERIAL GROWTH, AND A POSTOPERATIVE FUNDUS EXAMINATION INDICATED A PRIOR HISTORY OF SARCOIDOSIS AND A POSSIBLE EXCESSIVE IMMUNE RESPONSE. REPORTEDLY, THE FIBRINOUS REACTION RESULTED IN DECREASED VISUAL ACUITY LIKELY DUE TO PIGMENT ADHERENCE TO THE INTRAOCULAR LENS FROM RECENT INFLAMMATION, AND FIBRIN ADHESION ON THE TORIC LENS CAUSING DISPLACEMENT FROM ITS PROPER POSITION. THE REPORT NOTED THAT THE PATIENT'S INTRAOCULAR PRESSURE IS STABLE WITH NO FURTHER INTERVENTION.

  Patient problems: Eye Pain; Fibrosis; Visual Impairment

  MAUDE report 23065849 ↗
• InjurySep 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOLLOWING UNEVENTFUL BILATERAL CATARACT PLUS TRABECULAR MICROBYPASS STENT SYSTEM PROCEDURES PERFORMED ONE (1) WEEK APART, THE PATIENT PRESENTED POSTOPERATIVELY WITH FIBRIN OBSERVED IN BOTH EYES (OU). PER REPORT, THE PATIENT UNDERWENT AN ANTERIOR CHAMBER WASHOUT AND WAS TREATED WITH MEDICATION, WHICH STABILIZED THE PATIENT'S CONDITION. THROUGH FOLLOW-UP, THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED. PER REPORT, THERE WAS NO FURTHER INTERVENTION REQUIRED, AND IT IS UNKNOWN WHAT CONTRIBUTED TO THE FIBRINOUS REACTION. THE PATIENT STATUS WAS DESCRIBED AS INTRAOCULAR PRESSURE IS STABLE AND FAVORABLE WITH THE EVENT RESOLVED. THIS REPORT REFERENCES THE CASE OF FIBRIN ASSOCIATED WITH THE LEFT EYE (OS).

  Patient problems: Fibrosis; Inflammation

  MAUDE report 23059009 ↗
• InjurySep 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOLLOWING UNEVENTFUL BILATERAL CATARACT PLUS TRABECULAR MICROBYPASS STENT SYSTEM PROCEDURES PERFORMED ONE (1) WEEK APART, THE PATIENT PRESENTED POSTOPERATIVELY WITH FIBRIN OBSERVED IN BOTH EYES (OU). PER REPORT, THE PATIENT UNDERWENT AN ANTERIOR CHAMBER WASHOUT AND WAS TREATED WITH MEDICATION, WHICH STABILIZED THE PATIENT'S CONDITION. THROUGH FOLLOW-UP, THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED. PER REPORT, THERE WAS NO FURTHER INTERVENTION REQUIRED, AND IT IS UNKNOWN WHAT CONTRIBUTED TO THE FIBRINOUS REACTION. THE PATIENT STATUS WAS DESCRIBED AS INTRAOCULAR PRESSURE IS STABLE AND FAVORABLE WITH THE EVENT RESOLVED. THIS REPORT REFERENCES THE CASE OF FIBRIN ASSOCIATED WITH THE RIGHT EYE (OD).

  Patient problems: Fibrosis; Inflammation

  MAUDE report 23059007 ↗
• InjuryAug 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THROUGH FOLLOW-UP, THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED. PER REPORT, THE EVENT OCCURRED DUE TO STENT IMPLANTATION PRIOR TO CATARACT SURGERY, WHICH RESULTED IN EXCESSIVE BLEEDING. REPORTEDLY, THE SURGEON BELIEVES THAT PERFORMING IRRIGATION AND ASPIRATION (I/A) FOR AN EXTENDED PERIOD WILL STOP THE BLEEDING, AND IS SATISFIED THAT SURGICAL TECHNIQUE WILL RESOLVE THE ISSUE. THE REPORT NOTED THAT THE EVENT HAS RESOLVED, AND THE PATIENT'S CONDITION HAS STABILIZED WITH MEDICATION.

  Patient problems: Fibrosis; Inflammation

  MAUDE report 22865353 ↗
• InjuryAug 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THROUGH FOLLOW-UP, THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED. PER REPORT, THE EVENT OCCURRED DUE TO STENT IMPLANTATION PRIOR TO CATARACT SURGERY, WHICH RESULTED IN EXCESSIVE BLEEDING. REPORTEDLY, THE SURGEON BELIEVES THAT PERFORMING IRRIGATION AND ASPIRATION (I/A) FOR AN EXTENDED PERIOD WILL STOP THE BLEEDING, AND IS SATISFIED THAT SURGICAL TECHNIQUE WILL RESOLVE THE ISSUE. THE REPORT NOTED THAT THE EVENT HAS RESOLVED, AND THE PATIENT'S CONDITION HAS STABILIZED WITH MEDICATION.

  Patient problems: Fibrosis; Inflammation

  MAUDE report 22865318 ↗
• MalfunctionJun 10, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  THROUGH FOLLOW-UP, THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED. REPORTEDLY, THERE WAS NO ADVERSE PATIENT IMPACT OR INTERVENTION REQUIRED IN THE LEFT EYE (OS). THE REPORT ALSO NOTED "A NORMAL STENT PROCEDURE" AND "THERE WAS NOTHING PARTICULARLY NOTABLE" ABOUT THE PATIENT'S CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22178688 ↗
• MalfunctionMay 8, 2025Contamination; Contamination

  THROUGH FOLLOW-UP, THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED. PER REPORT, THE ORIGIN OF THE FIBROUS MATERIAL IS UNKNOWN, HOWEVER SINCE IT WAS OBSERVED DURING THE FIRST STENT DEPLOYMENT, THE SURGEON BELIEVES IT ORIGINATED FROM THE INTERNAL PART OF THE DEVICE. REPORTEDLY, THERE WAS NO ADVERSE PATIENT IMPACT OR ADDITIONAL TREATMENT REQUIRED. THE REPORT NOTED THE PATIENT STATUS AS "GOOD PROGRESS" WITH THE EVENT "RESOLVED".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21986131 ↗