iStent infinite iS3 (UDI 00853704002470)Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00853704002470), received between Sep 28, 2022 and Sep 28, 2026 — classified as 11 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 21 most recent of 21 reports, 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• MalfunctionAug 26, 2025Break; Break

  IT WAS REPORTED THAT THE TIP OF THE TROCAR BROKE OFF DURING THE IMPLANTATION OF THE THIRD STENT (OF THREE STENTS) FROM A TRABECULAR MICRO BYPASS STENT SYSTEM. PER REPORT, THE SURGEON INTRAOPERATIVELY REMOVED THE TROCAR FRAGMENT AND OBSERVED THAT ALL THREE (STENTS) WERE PROPERLY IMPLANTED. THERE WAS NO REPORT OF PATIENT INJURY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22899467 ↗
• MalfunctionAug 21, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THROUGH FOLLOW-UP, THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED. PER REPORT, POSTOPERATIVE VISUALIZATION OF THE STENT WAS DESCRIBED AS "A LOOSE STENT IN THE ANTERIOR CHAMBER (AC)" WHICH WAS REMOVED ON POSTOPERATIVE DAY ONE (1). REPORTEDLY, THE SURGEON BELIEVES "THE STENT MAY NOT HAVE BEEN PROPERLY POSITIONED DURING THE PROCEDURE", WHICH MAY HAVE CONTRIBUTED TO THE DISLODGED STENT. THE REPORT NOTED THAT THE STENT'S POSITIONING DID NOT RESULT IN ANY ADVERSE PATIENT IMPACT OR FURTHER INTERVENTION, AND THE EVENT HAS RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22865394 ↗
• InjuryMay 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOLLOWING A SUCCESSFUL TRABECULAR MICROBYPASS STENT SYSTEM PROCEDURE WITH THE IMPLANTATION OF THREE (3) WELL PLACED STENTS, A PATIENT WHO IS ON ANTIPLATELET MEDICATION PRESENTED ON POSTOPERATIVE DAY ONE (1) WITH WHAT WAS DESCRIBED AS A "LARGE" HYPHEMA" ASSOCIATED WITH ELEVATED INTRAOCULAR PRESSURE AND "HAND MOTION" VISION. REPORTEDLY, THE PATIENT WAS REFERRED TO A TERTIARY HOSPITAL FOR AN ANTERIOR CHAMBER (AC) WASHOUT TO TREAT THE HYPHEMA. THE REPORT NOTED THAT THE HYPHEMA IS BELIEVED TO BE DUE TO THE PATIENT'S ANTIPLATELET MEDICATION AND THE SURGEON IS SEEKING COUNSEL. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Hyphema; Intraocular Pressure Increased; Visual Impairment

  MAUDE report 22019080 ↗
• MalfunctionOct 9, 2024Break; Break

  IT WAS REPORTED THAT THE TROCAR BROKE DURING ATTEMPT TO IMPLANT THE FIRST STENT FROM A TRABECULAR MICROBYPASS STENT SYSTEM IN THE PATIENT'S RIGHT EYE (OD). PER REPORT, THE TROCAR FRAGMENT WAS REMOVED FROM THE EYE INTRAOPERATIVELY, AND A BACK-UP DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE REPORT NOTED THE EVENT AS "RESOLVED" WITH NO PATIENT INJURY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20409225 ↗
• InjuryOct 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED THROUGH FOLLOW-UP. PER REPORT, THE PUPIL OF THE RIGHT EYE (OD) WAS "PEAKED" ON POSTOPERATIVE DAY ONE (1), AND RESOLVED THREE (3) WEEKS LATER WITHOUT TREATMENT. REPORTEDLY, THE PUPIL HAS NORMALIZED AND THE PATIENT IS ASYMPTOMATIC. THE REPORT NOTED THAT THE SURGEON BELIEVES IT WAS A STEROID RESPONSE WITH NO FURTHER ISSUES ANTICIPATED.

  Patient problems: Eye Injury; Intraocular Pressure Increased

  MAUDE report 20364201 ↗
• InjuryJun 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED. PER REPORT, THE PATIENT PRESENTED SIX (6) MONTHS POSTOP WITH VISUAL FIELD LOSS "GREATER THAN 2.5 DB" IN THE LEFT EYE (OS), WHICH WAS DESCRIBED AS "MILD" AND "NON-SERIOUS" AND DID NOT REQUIRE INTERVENTION. THE REPORT NOTED THE EVENT RESOLVED APPROXIMATELY ONE (1) MONTH LATER.

  Patient problems: Visual Impairment

  MAUDE report 19609423 ↗
• InjuryNov 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOLLOWING A RIGHT EYE (OD) TRABECULAR MICROBYPASS STENT SYSTEM PROCEDURE, THE PATIENT PRESENTED APPROXIMATELY ONE (1) YEAR POSTOP WITH PROGRESSIVE SUPERIOR VISUAL FIELD LOSS, DESCRIBED AS "MILD AND NON-SERIOUS". PER REPORT, THE PATIENT RESUMED MEDICATION, AND IS BEING MONITORED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Seizures, Grand-Mal; Visual Impairment

  MAUDE report 18120592 ↗
• InjuryJun 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOLLOWING A RIGHT EYE (OD) TRABECULAR MICROBYPASS STENT SYSTEM PROCEDURE, THE PATIENT PRESENTED WITH POSTOPERATIVE "VISUAL ACUITY DECREASE BY TWO (2) LINES". THE PATIENT¿S PROGNOSIS WAS REPORTED AS MILD, NON-SERIOUS, WHICH RESOLVED WITHOUT ADDITIONAL INTERVENTION.

  Patient problems: Visual Impairment

  MAUDE report 17073249 ↗
• InjuryMar 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOLLOWING A RIGHT EYE (OD) TRABECULAR MICROBYPASS SYSTEM PROCEDURE, THE PATIENT PRESENTED APPROXIMATELY THREE (3) MONTHS POSTOP WITH A "NON SERIOUS" INTRAOCULAR PRESSURE (IOP) INCREASE DESCRIBED AS "IOP OVER TARGET", WHICH WAS TREATED WITH MEDICATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Intraocular Pressure Increased

  MAUDE report 16545950 ↗
• InjuryFeb 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THROUGH FOLLOW-UP, THE PATIENT''S LABORATORY RESULTS ASSOCIATED WITH VISUAL ACUITY WERE RECEIVED.

  Patient problems: Loss of Vision

  MAUDE report 16278458 ↗
• InjuryNov 17, 2022Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A RIGHT EYE (OD) TRABECULAR MICROBYPASS STENT SYSTEM PROCEDURE, THE ANTERIOR CAPSULE LENS WAS "BREACHED WITH THE INJECTOR", RESULTING IN A MODERATE DAMAGE TO THE ANTERIOR CAPSULE LENS WHICH REQUIRED A SURGICAL INTERVENTION- A PHACOEMULSIFICATION THE FOLLOWING DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Adhesion(s); Capsular Bag Tear; Corneal Endothelial Cell Loss; Eye Injury; Inflammation; Intraocular Pressure Increased; Loss of Vision; Uveitis

  MAUDE report 15818855 ↗
• MalfunctionOct 17, 2022Malposition of Device; Malposition of Device

  IT WAS REPORTED THAT DURING A RIGHT EYE (OD) A TRABECULAR MICROBYPASS STENT SYSTEM PROCEDURE, THE FIRST STENT FROM THE BACK-UP DEVICE WAS INADVERTENTLY IMPLANTED BELOW THE TRABECULAR MESHWORK (TM) IN THE SCLERAL SPUR. THERE WAS NO REPORT OF PATIENT INJURY, AND THE PROCEDURE WAS COMPLETED WITH A SUCCESSFUL IMPLANT OF THE SECOND STENT FROM THE BACK-UP DEVICE. THE REPORT THAT NOTED COMPROMISED INTRAOPERATIVE VIEW CONTRIBUTED TO THE REPORTED EVENT. ANY OMITTED INFORMATION WAS NOT AVAILABLE AT THE TIME OF REPORT.

  Patient problems: Foreign Body In Patient

  MAUDE report 15618900 ↗
• InjuryOct 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOLLOWING AN ISTENT INFINITE TRABECULAR MICROBYPASS SYSTEM PROCEDURE, THE PATIENT PRESENTED ONE (1) WEEK POSTOPERATIVELY WITH MILD IRITIS ASSOCIATED WITH 1+ CELL NOTED IN THE ANTERIOR CHAMBER, WHICH WAS TREATED WITH MEDICATION. THE REPORT NOTED THE EVENT AS ONGOING. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Cataract; Iritis

  MAUDE report 15559729 ↗
• InjurySep 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOLLOWING A LEFT EYE (OS) ISTENT INFINITE TRABECULAR MICROBYPASS SYSTEM PROCEDURE, THE PATIENT PRESENTED ON POSTOPERATIVE DAY ONE (1) WITH HYPHEMA CHARACTERIZED AS "MILD", AND ASSOCIATED WITH INCREASED INTRAOCULAR PRESSURE (IOP) WHICH WAS TREATED WITH MEDICATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Hyphema; Intraocular Pressure Increased

  MAUDE report 15499450 ↗