iStent GTS100RRecalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00853704002005), received between Aug 11, 2016 and Jan 29, 2019 — classified as 12 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Malposition of Device” (4 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• InjurySep 20, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A RIGHT EYE CATARACT PLUS TRABECULAR MICRO-BYPASS STENT PROCEDURE, THE INSERTER ENGAGED THE IRIS WHEN THE STENT WAS RE-GRASPED BY THE SURGEON. PER REPORT, THE VISIBILITY WAS COMPROMISED DUE TO HEME. AN IRIDODIALYSIS WAS OBSERVED INTRAOPERATIVELY AND THE IRIS EXTRUDED THE WOUND. THE SURGEON ATTEMPTED TO PLACE THE IRIS BACK IN THE ANTERIOR CHAMBER AND SUTURES WERE REQUIRED. THE STENT WAS REMOVED FROM THE EYE AND THE PROCEDURE WAS ABORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Eye Injury

  MAUDE report 7895742 ↗
• MalfunctionMar 28, 2018Malposition of Device; Malposition of Device

  CLINICAL FOLLOW-UP WAS REQUESTED AND ON 04/16/2018 THE SURGEON PROVIDED THE FOLLOWING ADDITIONAL DETAILS; THE ISTENT PROCEDURE OF THE RIGHT EYE WAS ABORTED DUE TO PATIENT MOVEMENT. THE PATIENT STATUS AND PROGNOSIS WAS REPORTED TO BE GOOD.

  Patient problems: Foreign Body In Patient; No Known Impact Or Consequence To Patient

  MAUDE report 7378668 ↗
• MalfunctionFeb 27, 2018Obstruction of Flow; Malposition of Device; Obstruction of Flow; Malposition of Device

  IT WAS REPORTED THROUGH A POST-MARKET CLINICAL TRIAL THAT FOLLOWING AN UNCOMPLICATED CATARACT SURGERY AND IMPLANTATION OF A TRABECULAR MICRO-BYPASS STENT A PATIENT PRESENTED ON POSTOPERATIVE DAY EIGHT (8) AND ¿STENT MIGRATION¿ WAS OBSERVED. THE STENT WAS INITIALLY IMPLANTED AT THE 3:00 POSITION. A (B)(6) PERFORMED ON POSTOPERATIVE DAY 15 ((B)(6) 2017) SHOWED AN ARTIFACT THAT MAY POSSIBLY HAVE BEEN THE STENT; HOWEVER, THE DOCTOR WAS UNABLE TO CONFIRM VIA GONIOSCOPY. ON POSTOPERATIVE DAY 26 ((B)(6) 2018), (B)(6) CONFIRMED THE PRESENCE OF THE STENT AT APPROXIMATELY THE 2:30 POSITION. THE STATUS OF THE STENT IS CURRENTLY ¿UNCHANGED¿ AND HAS NOT RESULTED IN ANY ADVERSE IMPACT TO THE PATIENT. OF NOTE THE PATIENT PRESENTED 3 HOURS POST-OPERATION WITH AN IOP INCREASE GREATER THAN OR EQUAL TO 10MM HG ABOVE BASELINE AND WAS PLACED BACK ON A IOP LOWERING MEDICATION (SIMBRINZA BID). THE EVENT WAS REPORTED TO HAVE RESOLVED BY POST OP DAY ONE AS THE PATIENT¿S IOP LOWERING MEDICATIONS WERE DISCONTINUED PRIOR TO SURGERY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7301556 ↗
• MalfunctionJan 8, 2018Malposition of Device; Malposition of Device

  THE SURGEON REPORTED THAT DURING A TRABECULAR MICRO-BYPASS STENT PROCEDURE ON THE LEFT EYE, THE STENT WAS LOST IN THE CILIARY BODY BAND. THE SURGEON ATTEMPTED TO RETRIEVE THE STENT; HOWEVER, IT WAS PUSHED IN FURTHER AND COULD NOT BE RETRIEVED. A BACKUP STENT WAS SUCCESSFULLY IMPLANTED. THERE WAS NO ADVERSE IMPACT TO THE PATIENT. CLINICAL FOLLOW-UP WAS REQUESTED AND ON (B)(6) 2018 THE SURGEON PROVIDED THE FOLLOWING ADDITIONAL DETAILS. THE STENT COULD NOT BE VISUALIZED IN THE CILIARY BODY DURING POSTOPERATIVE IMAGING. THE BACKUP STENT THAT WAS PLACED IS WELL-POSITIONED IN SCHLEMM¿S CANAL. THERE HAS BEEN NO ADVERSE IMPACT TO THE PATIENT WHO WILL BE MONITORED. THE PATIENT¿S CURRENT STATUS AND PROGNOSIS IS ¿EXCELLENT¿ AND THE EVENT HAS RESOLVED.

  Patient problems: Foreign Body In Patient

  MAUDE report 7173705 ↗
• InjurySep 22, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE SURGEON REPORTED THAT A CLINICAL TRIAL PATIENT PRESENTED ON POSTOPERATIVE DAY ONE (1) WITH REPORT OF A MILD INTERMITTENT FOREIGN BODY SENSATION. THE PATIENT WAS PRESCRIBED ARTIFICIAL TEARS. ON POSTOPERATIVE DAY 15 THE PATIENT PRESENTED WITH BLURRY VISION/VISUAL DISTURBANCE FOR WHICH ARTIFICIAL TEARS WERE CONTINUED.

  Patient problems: Blurred Vision

  MAUDE report 6888975 ↗
• InjurySep 21, 2017Obstruction of Flow; Obstruction of Flow

  THE SURGEON REPORTED THAT A CLINICAL TRIAL PATIENT PRESENTED APPROXIMATELY 12 WEEKS POSTOPERATIVELY WITH STENT OBSTRUCTION. THE OBSTRUCTION WAS TREATED WITH YAG LASER. THE PATIENT IS REPORTEDLY RECOVERING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6884803 ↗
• InjuryAug 18, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THROUGH REVIEW OF THE ARTICLE "IMPLANTATION OF TRABECULAR MICRO-BYPASS STENT USING A NOVEL "LANDING STRIP" TECHNIQUE" IT WAS LEARNED THAT FOLLOWING ISTENT IMPLANTATION, TWO EYES PRESENTED WITH AN INCREASED INTRAOCULAR PRESSURE (IOP) THAT ULTIMATELY REQUIRED TRABECULECTOMY. THE STUDY WAS COMPRISED OF 34 EYES FROM 30 PATIENTS (21 FEMALE, 9 MALE) WITH A MEAN AGE OF 74. THE ISTENT PROCEDURES WERE COMPLETED BETWEEN MAY 2014 AND FEBRUARY 2015. THE PURPOSE OF THE STUDY WAS TO DESCRIBE A NOVEL TECHNIQUE OF CREATING A LANDING STRIP WITHIN THE TRABECULAR MESHWORK TO GUIDE TRABECULAR MICRO-BYPASS STENT (ISTENT) IMPLANTATION IN PATIENTS WHO UNDERWENT PHACOEMULSIFICATION. THE TWO PATIENTS REQUIRING TRABECULECTOMY INITIALLY UNDERWENT PARACENTESIS TO REMOVE VISCOELASTIC MATERIAL. ONE PATIENT CONTINUED TO HAVE ELEVATED IOP RANGING FROM 38-44 MM HG AT SUBSEQUENT FOLLOW-UP VISITS. TRABECULECTOMY WAS PERFORMED THREE WEEKS AFTER THE ISTENT SURGERY. FOLLOWING TRABECULECTOMY, THE IOP IMPROVED TO 12 MM HG AT THE ONE MONTH FOLLOW-UP. THE ARTICLE REPORTED THAT STENT FAILURE MAY HAVE OCCURRED DUE TO AQUEOUS OUTFLOW OBSTRUCTION PAST SCHLEMM'S CANAL OR POSTOPERATIVE TRABECULAR MESHWORK DYSFUNCTION.

  Patient problems: Intraocular Pressure Increased

  MAUDE report 6805940 ↗
• InjuryJun 28, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS INITIALLY REPORTED THAT THE STENT COULD NOT BE IMPLANTED BECAUSE THE VIEW WAS OBSCURED BY HEME, AND THE PROCEDURE WAS ABORTED. ON (B)(6)2017, THE SURGEON PROVIDED THE FOLLOWING ADDITIONAL EVENT DETAILS. THE SURGEON HAD DIFFICULTY IMPLANTING THE STENT, AND AFTER REGRASPING SEVERAL TIMES, THE PROCEDURE WAS ABORTED. AT THE TIME, THERE WAS NO INDICATION OF ANY ADVERSE EFFECTS. POSTOPERATIVELY, THE PATIENT PRESENTED WITH HYPOTONY. THE PATIENT¿S INTRAOCULAR PRESSURE (IOP) HAS RANGED FROM 3-5 MM HG. THE SURGEON CONFERRED WITH THE GLAUKOS MEDICAL MONITOR ON (B)(6)2017 WHO REPORTED THAT THERE IS CONCERN THAT A CYCLODIALYSIS CLEFT MAY HAVE BEEN CREATED AND INDICATED THAT A GONIOSCOPY WOULD HELP TO CONFIRM THIS. THE GLAUKOS MEDICAL MONITOR AND THE SURGEON DISCUSSED DIFFERENT TREATMENT OPTIONS INCLUDING A CYCLOPLEGIC, STEROIDS, LASER OR OTHER SURGICAL INTERVENTIONS IF THE HYPOTONY PERSISTS. THE SURGEON REPORTED THAT THE PATIENT WAS A WEEK OUT FROM SURGERY WITH INCREASING FLARE AND DECREASED VISUAL ACUITY FROM 20/40 TO 20/80. THE PATIENT WAS PRESCRIBED A CYCLOPLEGIC, ILEVRO, AND SWITCHED FROM PREDNISOLONE ACETATE TO DUREZOL FOUR TIMES PER DAY. ON (B)(6)2017, THROUGH DISCUSSION WITH THE G

  Patient problems: Eye Injury; Intraocular Pressure, Delayed, Uncontrolled; Loss of Vision

  MAUDE report 6675151 ↗
• InjuryJun 13, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE SURGEON REPORTED THAT DURING AN ISTENT PROCEDURE, THERE WAS TOO MUCH PATIENT MOVEMENT. THIS RESULTED IN THE IRIS BEING TORN AWAY FROM THE ANGLE. THE TEAR WAS APPROXIMATELY TWO TO THREE CLOCK HOURS. THE ISTENT PROCEDURE WAS ABORTED AND THE IRIS WAS SUTURED BACK IN PLACE. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE SURGEON.

  Patient problems: Eye Injury; Hyphema

  MAUDE report 6638923 ↗
• MalfunctionApr 19, 2017Material Fragmentation; Material Fragmentation

  THE SURGEON INITIALLY REPORTED THAT THE STENT FELL OFF THE INSERTER. WHILE ATTEMPTING TO REGRASP THE STENT, PRIOR TO INSERTING THE DEVICE INTO THE EYE, THE STENT ¿CRUMBLED.¿ FOLLOW-UP WAS REQUESTED AND ON 04/13/2017 THE SURGEON PROVIDED THE FOLLOWING EVENT DETAILS. THE SURGEON ATTEMPTED TO IMPLANT THE STENT, BUT WAS UNABLE TO GET IT INTO THE CANAL. THE STENT WAS REGRASPED AND OBSERVED TO BE SEATED ON THE INSERTER IN A ¿COCKEYED¿ MANNER. AFTER REMOVING THE DEVICE FROM THE EYE, THE SURGEON VIEWED THE ISTENT UNDER THE MICROSCOPE AND NOTED THAT THE STENT APPEARED BENT. THE STENT WAS RELEASED FROM THE INSERTER, AND FRAGMENTED AT THE AREA BETWEEN THE SNORKEL AND BODY. A BACKUP STENT WAS IMPLANTED WITHOUT INCIDENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6505596 ↗
• InjuryMar 24, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE SURGEON INITIALLY REPORTED THAT AFTER SEVERAL ATTEMPTS THEY COULD NOT SUCCESSFULLY IMPLANT THE ISTENT, AND THE PROCEDURE WAS ABORTED. CLINICAL FOLLOW-UP WAS REQUESTED, AND ON (B)(6) 2017, THE SURGEON PROVIDED THE FOLLOWING INITIAL EVENT DETAILS. THE SURGEON WAS UNABLE TO IMPLANT THE ISTENT DUE TO COMPROMISED/OBSCURED VISUALIZATION. THERE WAS TRANSIENT INTRAOPERATIVE BLEEDING THAT WAS SELF-RESOLVING. DURING THE PATIENT¿S ONE WEEK POSTOPERATIVE VISIT, 2+ CELL AND FLARE WAS NOTED IN THE ANTERIOR CHAMBER. PROGNOSIS WAS REPORTED TO BE GOOD. CLINICAL FOLLOW-UP WAS REQUESTED, AND ON (B)(6) 2017 THE SURGEON PROVIDING THE FOLLOWING EVENT DETAILS. THE PATIENT PRESENTED WITH POSTOPERATIVE IRITIS REQUIRING PREDNISOLONE ACETATE AND PROLENSA TOPICALLY. THE ADVERSE EVENT WAS REPORTED TO BE ONGOING/PERSISTENT, ALTHOUGH THE PATIENT WAS REPORTED TO BE SUBSTANTIALLY IMPROVED AND IS SCHEDULED TO HAVE A RECHECK ON (B)(6) 2017. ADDITIONAL INFORMATION WILL BE REQUESTED.

  Patient problems: Iritis

  MAUDE report 6434040 ↗
• InjuryMar 8, 2017Invalid Sensing; Invalid Sensing

  A PATIENT UNDERWENT AN UNEVENTFUL CATARACT AND ISTENT SURGERY OF THE RIGHT EYE ON (B)(6) 2017. ON (B)(6) 2017 THE PATIENT PRESENTED WITH AN IOP OF 42.5 MM HG (MEAN). PREOPERATIVELY THE PATIENT WAS ON LATANOPROST FOR HER PRIMARY OPEN ANGLE GLAUCOMA. THE PATIENT WAS PLACED BACK ON LATANOPROST AND COMBIGAN WAS ADDED TWICE A DAY FOR THE INCREASED IOP. ON (B)(6) 2017 THE PATIENT'S IOP IMPROVED TO 19 MM HG. THE ADVERSE EVENT WAS REPORTED TO HAVE RECOVERED WITH SEQUELAE AS THE IOP IS NOW BELOW BASELINE AND THE PATIENT WILL CONTINUE MEDICATIONS.

  Patient problems: Intraocular Pressure Increased

  MAUDE report 6388217 ↗
• InjuryNov 11, 2016Use of Device Problem; Use of Device Problem

  THE SURGEON INITIALLY REPORTED BEING UNABLE TO IMPLANT THE ISTENT DUE TO PATIENT ANATOMY THAT PRECLUDED IMPLANTATION. CLINICAL FOLLOW-UP WAS REQUESTED AND ON (B)(6) 2016 THE SURGEON PROVIDED THE FOLLOWING ADDITIONAL EVENT DETAILS. IMPLANTATION WAS NOT SUCCESSFUL DUE TO COMPROMISED VISUALIZATION. DURING SURGERY, THE ISTENT WAS LOST. THE SURGEON THOROUGHLY PERFORMED I AND A AND WAS UNABLE TO VISUALIZE THE ISTENT WITH POSTOPERATIVE IMAGING. AT THE ONE MONTH POST-OPERATION EXAM THE PATIENT COMPLAINED OF IRRITATION LIKELY DUE TO IOP LOWERING DROPS. THE PATIENTS VISION WAS REPORTED TO HAVE IMPROVED AND THE IOP HAD RETURNED TO BASELINE. THE SURGEON PROVIDED THE FOLLOWING ADDITIONAL INFORMATION TO GLAUKOS ON 10/31/2016. THE SURGEON REPORTED THAT THEY FELT CONFIDENT THAT THE ISTENT WAS SUCCESSFULLY REMOVED VIA I AND A. THE PATIENT PRESENTED POST-OPERATIVELY WITH HYPHEMA RESULTING IN ELEVATED IOP. AT THE TIME OF IOP RISE THE PATIENT WAS ON MORE GLAUCOMA MEDICATIONS COMPARED TO PRE-OPERATION. DUE TO THE IOP INCREASE, THE SURGEON REPORTED CORNEAL EDEMA, BCVA LOSS GREATER THAN 2 LINES COMPARED TO PREOPERATIVE BCVA (THOUGH BOTH IMPROVED BY THE 1 WEEK POST-OPERATIVE EXAM). THE INFLAMMATION WAS T

  Patient problems: Hyphema; Intraocular Pressure Increased; Loss of Vision

  MAUDE report 6097139 ↗
• InjuryNov 3, 2016Obstruction of Flow; Malposition of Device; Obstruction of Flow; Malposition of Device

  THE SURGEON REPORTED THAT AN ISTENT PATIENT PRESENTED POSTOPERATIVELY WITH IOP SPIKES WHICH WERE AT FIRST THOUGHT TO BE STEROID RESPONDER RELATED. DURING POSTOPERATIVE GONIOSCOPY EXAM THE SURGEON REPORTED THAT THE ISTENT WAS IMPLANTED IN THE TRABECULAR MESHWORK AND TILTED WITH IRIS OBSTRUCTING THE OPENING OF THE STENT. A MEDICAL MONITOR CONSULT WAS INITIATED ON (B)(6) 2016. CLINICAL FOLLOW UP WAS REQUESTED AND ON 10/27/2016 THE SURGEON PROVIDED THE FOLLOWING DETAILS. CATARACT SURGERY WITH ISTENT IMPLANTATION WAS UNEVENTFUL. THE STATUS OF THE IMPLANTED STENT AS CONFIRMED BY POSTOPERATIVE IMAGING WAS REPORTED TO BE MALPOSITIONED. THE MALPOSITIONING RESULTING IN UVEITIS AND PRESSURE SPIKES. THE STENT IS PLANNED TO BE EXPLANTED ON (B)(6) 2016. THE PATIENT CONTINUES TO HAVE UVEITIS, OCULAR HYPERTENSION AND DECREASED VISUAL ACUITY. ADDITIONAL INFORMATION WILL BE REQUESTED.

  Patient problems: Foreign Body In Patient; Intraocular Pressure Increased; Uveitis

  MAUDE report 6077088 ↗
• InjuryAug 11, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE SURGEON INITIALLY REPORTED BEING UNABLE TO IMPLANT THE ISTENT DUE TO COMPROMISED VISUALIZATION. CLINICAL FOLLOW-UP WAS REQUESTED AND ON 7/22/2016 THE SURGEON PROVIDED THE FOLLOWING ADDITIONAL EVENT DETAILS. THE PATIENT PRESENTED WITH PERSISTING HYPHEMA 1 DAY POST OPERATION RESULTING IN DECREASED VISUAL ACUITY. THE HYPHEMA RESOLVED BY THE 1 WEEK POST-OPERATIVE EXAM. THE PATIENT'S VISUAL ACUITY IMPROVED TO 20/40 AND WAS REPORTED TO BE DOING WELL. ADDITIONAL FOLLOW-UP HAS BEEN REQUESTED.

  Patient problems: Hyphema; Loss of Vision

  MAUDE report 5869761 ↗
• InjuryAug 11, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL FOLLOW-UP WAS RECEIVED ON 10/19/2016 AND THE SURGEON PROVIDED THE FOLLOWING DETAILS. THE PATIENT STATED THAT THEIR VISION HAD SIGNIFICANTLY IMPROVED ON THEIR LAST VISIT AND THE SURGEON REPORTED THAT THEIR IOP WAS UNDER CONTROL WITH MEDICATION. THE ADVERSE EVENTS WERE REPORTED TO HAVE RESOLVED WITH A FEW RED BLOOD CELLS STILL PRESENT IN THE ANTERIOR CHAMBER.

  Patient problems: Hyphema; Intraocular Pressure Increased; Loss of Vision; Pain

  MAUDE report 5869538 ↗