iStentRecalls & reported problems across all models

We found 2 models of iStent by Glaukos Corporation in the FDA's device registry (GUDID). Together they are named in 124 adverse event reports in the FDA's MAUDE database, received between Aug 11, 2016 and Aug 29, 2024 — classified as 90 injuries, 34 malfunctions.

The most frequently reported specific device problem is “Malposition of Device” (25 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 problems

iStent models

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

• iStent GTS100L

  Intraocular Pressure Lowering Implant
  107 reports
• iStent GTS100R

  Intraocular Pressure Lowering Implant
  17 reports

Recent iStent adverse event reports

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

• InjuryAug 29, 2024Obstruction of Flow; Obstruction of Flow

  THE FOLLOWING WAS REPORTED THROUGH A REVIEW OF THE ARTICLE TITLED, "ONE-YEAR COMPARATIVE ANALYSIS BETWEEN STANDALONE ISTENT IMPLANTATION VERSUS COMBINED ISTENT IMPLANTATION WITH PHACOEMULSIFICATION." REPORTEDLY FOLLOWING TRABECULAR MICROBYPASS STENT PROCEDURES IN A TOTAL OF FORTY-EIGHT (48) EYES, TWO (2) OPERATIVE EYES PRESENTED DURING A POSTOPERATIVE EXAMINATION WITH STENT OCCLUSION WITH IRIS TISSUE. PER REPORT, NONE OF THE PATIENTS REQUIRED A SECONDARY GLAUCOMA PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED. PLEASE SEE ATTACHED ARTICLE FOR FURTHER DETAILS. REFERENCE DOI:10.1177/11206721241273678.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Uveitis

  MAUDE report 20100535 ↗
• MalfunctionMay 15, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT PRIOR TO A TRABECULAR MICRO BYPASS STENT PROCEDURE, A POTENTIAL FOREIGN PARTICULATE WAS OBSERVED IN THE STERILE WRAPPING OF AN UNOPENED DEVICE. THERE WAS NO PATIENT CONTACT OR INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11829954 ↗
• InjuryDec 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH A CLINICAL TRIAL THAT FOLLOWING LEFT EYE TRABECULAR MICRO BYPASS STENT PROCEDURE, A SUBJECT PRESENTED WITH MODERATE IOP INCREASE THIRTY-TWO (32) MONTHS POSTOPERATIVELY. A SELECTIVE LASER TRABECULOPLASTY (SLT) WAS PERFORMED AND THE PATIENT WAS REPORTED ON ONE (1) GLAUCOMA MEDICATION (LATANOPROST) AND WAS BEING MONITORED. THROUGH FOLLOW-UP, IT WAS REPORTED THAT DURING THE MOST RECENT FOLLOW-UP VISIT THE SURGEON WAS COMFORTABLE WITH THE PATIENT IOP VALUE, AND THERE WAS NO CHANGE IN MEDICATION WITH NO NEW ADVERSE EVENT.

  Patient problems: Intraocular Pressure Increased

  MAUDE report 11008601 ↗
• InjuryJun 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CLINICAL FOLLOW-UP WAS RECEIVED WITH THE FOLLOWING ADDITIONAL INFORMATION. REPORTEDLY, THE PATIENT PRESENTED APPROXIMATELY TWO (2) YEARS AND FOUR (4) MONTHS POST-OP WITH INTRAOCULAR INFLAMMATION (IRITIS) REMAINING OR ARISING AFTER COMPLETION OF THE PROTOCOL¿S SPECIFIED MEDICATION REGIMEN. THE INFLAMMATION WAS CHARACTERIZED AS MODERATE (POSSIBLY RELATED TO THE STUDY TREATMENT) AND WAS TREATED WITH MEDICATION. THE PATIENT¿S MOST RECENT PROGNOSIS WAS REPORTED AS ¿RECOVERED¿. THE SURGEON DOUBTS THE IRITIS WAS CAUSED BY THE STENT, BUT COULD NOT BE COMPLETELY RULE IT OUT. THIS REPORT REFERENCE MFR# REFERENCE: (B)(4). PLEASE REFERENCE MFR# REFERENCE (B)(4) THE INITIAL REPORTED OCCURENCE.

  Patient problems: Iritis

  MAUDE report 10115257 ↗
• MalfunctionJan 6, 2020No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED DURING A LEFT EYE CATARACT PLUS TRABECULAR MICRO BYPASS STENT PROCEDURE, THE SURGEON OBSERVED A PARTICULATE DESCRIBED AS A ¿SMALL WHITE FRAGMENT¿. PER REPORT, THE PARTICULATE APPEARED TO COME FROM THE LUMEN OF THE STENT, OBSERVED AFTER IMPLANTATION. THE SURGEON MANAGED TO REMOVE PART OF THE PARTICULATE, BUT SOME PARTICULATE REMAINED ON THE STENT. SUBSEQUENTLY, THE SURGEON REMOVED THE STENT FROM THE PATIENT¿S EYE INTRAOPERATIVELY. A BACK-UP DEVICE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. ADDITIONAL INFORMATION HAS BEEN REQUESTED

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9555146 ↗
• MalfunctionDec 19, 2019Malposition of Device; Malposition of Device

  IT WAS INITIALLY REPORTED THAT DURING A LEFT EYE CATARACT PLUS TRABECULAR MICRO BYPASS STENT PROCEDURE, THE SURGEON WAS UNABLE TO PROPERLY IMPLANT THE STENT IN THE RIGHT POSITION (IN THE TRABECULAR MESHWORK). PER REPORT, SURGICAL TECHNIQUE AND EXPERIENCE WITH DEVICE CONTRIBUTED TO THE REPORTED EVENT. A BACK-UP DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY AND THERE WAS NO SURGICAL OR MEDICAL INTERVENTION REQUIRED. ADDITIONAL INFORMATION WAS REQUESTED AND THE SURGEON REPORTED THAT AFTER IMPLANTATION ATTEMPT, THE STENT COULD NOT BE LOCATED. IT IS UNKNOWN IF THE DEVICE REMAINS IN THE PATIENT'S EYE AS THE SURGEON COULD NOT LOCATE IT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 9497111 ↗
• InjuryNov 7, 2019Malposition of Device; Malposition of Device

  INITIALLY, A TRABECULAR MICRO BYPASS STENT PATIENT REPORTED THE FOLLOWING EVENT. FOLLOWING AN UNEVENTFUL LEFT EYE CATARACT PLUS STENT PROCEDURE, THE PATIENT PRESENTED ON POST-OP DAY ONE (1) WITH ELEVATED IOP AND THE SURGEON WAS UNABLE TO VISUALIZE THE STENT. ADDITIONAL GLAUCOMA MEDICATIONS WERE PRESCRIBED AND THE IOP IMPROVED. REPORTEDLY, THE PATIENT WAS INFORMED THAT THE STENT WAS "LOST", AND A STENT WAS SUBSEQUENTLY IMPLANTED IN THE LEFT EYE APPROXIMATELY TWO (2) WEEKS FOLLOWING THE INITIAL IMPLANT. THE PATIENT ALSO REPORTED BLURRY VISION AND "ABNORMAL MACULA" FOLLOWING THE INITIAL OPERATION. PER PATIENT, THE MACULA HAS AN "ABNORMAL CURVE". THROUGH FOLLOW-UP, THE SURGEON PROVIDED THE FOLLOWING ADDITIONAL INFORMATION. THE PROCEDURE WAS UNEVENTFUL AND THE SURGEON WAS UNCERTAIN ABOUT WHAT CONTRIBUTED TO STENT MALPOSITIONING. POSTOPERATIVELY, THE STENT WAS VISUALIZED IN ANGLE, BUT NOT IN THE TRABECULAR MESHWORK (TM). THE STENT POSITIONING DID NOT RESULT IN ANY ADVERSE IMPACT. PER REPORT, THE STENT WAS REPOSITIONED AT PATIENT REQUEST. THE SURGEON NOTED THAT THE IOP DID NOT REQUIRE INTERVENTION BEYOND STANDARD POSTOP REGIMEN AS IT IS EXPECTED TO RISE AT DAY ONE (1) POSTOP FOR GLAUCOMA

  Patient problems: Intraocular Pressure Increased

  MAUDE report 9291770 ↗
• MalfunctionAug 7, 2019Obstruction of Flow; Obstruction of Flow

  THE FOLLOWING WAS REPORTED THROUGH A REVIEW OF AN ARTICLE TITLED "CASE SERIES OF COMBINED ISTENT IMPLANTATION AND PHACOEMULSIFICATION IN EYES WITH PRIMARY ANGLE CLOSURE DISEASE: ONE-YEAR OUTCOMES". FOLLOWING CATARACT PLUS TRABECULAR MICRO BYPASS STENT PROCEDURES, THERE WERE OCCLUSION OF STENTS WITH IRIS IN TEN (10 ) EYES, HYPHEMA (7), IRIS ATROPHY (2), ELEVATED IOP (1), IRIDODIALYSIS (1), CORNEAL EDEMA (1). THE REPORT INDICATES THAT ALL COMPLICATIONS WERE MANAGED CONSERVATIVELY WITHOUT REQUIRING A SECOND SURGERY AND THERE WAS NO OCCURRENCE OF SIGHT-THREATENING COMPLICATIONS. REPORTEDLY, AMONG THE TEN (10) EYES WITH REPORTED STENT OCCLUSION, EIGHT (8) EYES HAD A SINGLE STENT IMPLANTED, AND TWO (2) EYES HAD TWO (2) STENTS IMPLANTED. THE REPORT NOTES THAT THE OCCLUSION OCCURRED IN SEVEN (7) EYES WITHIN THE FIRST 2 MONTHS AFTER THE SURGERY AND GLAUCOMA MEDICATIONS WERE SUBSEQUENTLY REQUIRED IN THREE (3) OF THE TEN (10) EYES. IN ADDITION, FIVE (5) OF THE EIGHT (8) EYES WITH A SINGLE STENT IN SITU WAS FULLY OCCLUDED WITH IRIS AND THE REMAINING FIVE (5) EYES PRESENTED WITH PARTIALLY OCCLUDED STENTS. THROUGH FOLLOW UP DEVICE IDENTIFIERS WERE PROVIDED FOR 2 OF THE REPORTED STENT OCCLUSION E

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8870403 ↗
• InjuryJul 10, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOLLOWING A RIGHT EYE CATARACT PLUS TRABECULAR MICRO BYPASS STENT PROCEDURE, THE SURGEON EXPLANTED THE STENT APPROXIMATELY 2+ YEARS POSTOPERATIVELY DUE TO LACK OF DESIRED IOP REDUCTION. SUBSEQUENTLY, THE SURGEON PERFORMED AN AB INTERNO TRABECULECTOMY (KAHOOK DUAL BLADE). ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Therapeutic Response, Decreased

  MAUDE report 8778848 ↗
• MalfunctionJun 26, 2019Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THROUGH A CLINICAL TRIAL THAT A SUBJECT PRESENTED WITH STENT OBSTRUCTION IN THE LEFT EYE; APPROXIMATELY, ONE (1) YEAR POSTOPERATIVELY. THE OSTIUM OF STENT WAS OBSERVED COVERED WITH THE TRABECULAR MESHWORK (TM) TISSUE. THERE WAS NO REPORT OF SURGICAL/MEDICAL INTERVENTION PERFORMED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8737461 ↗
• InjuryMay 28, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED FOLLOWING CATARACT PROCEDURE, THE PATIENT MOVED DURING IMPLANTATION ATTEMPT OF A TRABECULAR MICRO BYPASS STENT. DUE TO PATIENT MOVEMENT, AN INTRAOPERATIVE IRIS TEAR OCCURRED. THE STENT PROCEDURE WAS ABORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Eye Injury

  MAUDE report 8647451 ↗
• InjuryMar 20, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A LEFT EYE OMNI PROCEDURE, A TRABECULAR MICRO BYPASS STENT DISLODGED FROM THE TRABECULAR MESHWORK (TM) AFTER THE GONIO EXAMINATION. INITIALLY, THE PATIENT UNDERWENT THE LEFT EYE CATARACT PLUS TRABECULAR MICRO BYPASS STENT PROCEDURE APPROXIMATELY TWENTY (20) MONTHS PRIOR TO OMNI PROCEDURE. THE STENT WAS REMOVED FROM THE PATIENT¿S EYE SUCCESSFULLY. ADDITIONAL INFORMATION WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8438432 ↗
• MalfunctionMar 18, 2019Malposition of Device; Malposition of Device

  IT WAS REPORTED THAT FOLLOWING A RIGHT EYE CATARACT PROCEDURE, A TRABECULAR MICRO BYPASS STENT WAS ¿LOST¿ DURING IMPLANTATION ATTEMPT. THERE WAS NO REPORT OF PATIENT¿S INJURY. ADDITIONAL INFORMATION (CLARIFICATION) WAS REQUESTED, BUT FURTHER DETAILS WERE NOT AVAILABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 8428945 ↗
• MalfunctionJan 29, 2019No Apparent Adverse Event; No Apparent Adverse Event

  INITIALLY, IT WAS REPORTED THAT ¿BLACK DOTS¿ WERE OBSERVED ON THE PACKAGING A TRABECULAR MICRO BYPASS STENT PRIOR TO PATIENT CONTACT. A BACK DEVICE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY.

  Patient problems: No Patient Involvement

  MAUDE report 8287451 ↗
• InjuryJan 7, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOLLOWING CATARACT SURGERY, DURING ATTEMPT TO IMPLANT A STENT FROM A TRABECULAR MICRO-BYPASS STENT, THE PATIENT MOVED RESULTING IN AN IRIDODIALYSIS. THE PROCEDURE WAS ABORTED. ADDITIONAL INFORMATION IS BEING REQUESTED.

  Patient problems: Eye Injury

  MAUDE report 8224671 ↗

Other Glaukos Corporation products

• iStent Infinite2 models · 59 reports