iStent inject G2-M-ISRecalls & reported problems

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 00853704002203), received between Sep 12, 2018 and Sep 17, 2024 — classified as 20 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Malposition of Device” (10 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 25 most recent of 33 reports, in the reporter's own words as published by the FDA.

• InjurySep 17, 2024Obstruction of Flow; Obstruction of Flow

  THE FOLLOWING WAS INITIALLY 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. THROUGH FOLLOW-UP, THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED. PER REPORT, APPROXIMATELY ONE (1) YEAR POSTOP FOLLOWING A BILATERAL PROCEDURE (OU), BOTH STENT LUMEN WERE OCCLUDED BY PERIPHERAL ANTERIOR SYNECHIAE (PAS). REPORTEDLY, THE PATIENT IS CURRENTLY ON FOUR (4) GLAUCOMA MEDICATIONS (OU). THE REPORT NOTED THAT BOTH EYES WERE "PHAKIC", AND THE SURGEON BELIEVES "FLOPPY IRIS" MAY HAVE CONTRIBUTED TO THE EVENT. PLEASE SEE ATTACHED ARTICLE FOR FURTHER DETAILS. REFERENCE DOI:10.1177/11206721241273678. THIS REPORT REFERENCES THE REPORT OF STENT OBSTRUCTION AND PERIPHERAL ANTERIOR SYNECHIAE ASSOCIATED WITH THE G2-M-IS DEVICE IN THE LEFT EYE (OS).

  Patient problems: Adhesion(s)

  MAUDE report 20242391 ↗
• InjuryOct 31, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED THROUGH A REVIEW OF THE ARTICLE TITLED "COMPARING OUTCOMES OF PHACOEMULSIFICATION AND ENDOCYCLOPHOTOCOAGULATION WITH EITHER DUAL BLADE GONIOTOMY (PECK) OR TWO TRABECULAR STENTS (ICE2)." REPORTED, FOLLOWING CATARACT PLUS TRABECULAR MICROBYPASS STENT PROCEDURES IN A TOTAL OF FORTY-TWO (42) PATIENTS, ONE (1) PATIENT PRESENTED POSTOP WITH A PERSISTENT HYPHEMA BEYOND THREE (3) MONTHS IN THE LEFT OPERATIVE EYE (OS), AND ONE (1) PATIENT PRESENTED WITH CYSTOID MACULAR EDEMA (CME) IN THE RIGHT OPERATIVE EYE (OD). THROUGH FOLLOW-UP, THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED. PER REPORT, THERE WAS NO MEDICAL OR SURGICAL INTERVENTION REQUIRED TO TREAT THE CASE OF HYPHEMA, WHICH RESOLVED BY POSTOP MONTH SIX (6). PER REPORT, THE CASE OF CYSTOID MACULAR EDEMA (CME) WAS "MORE LIKELY" ASSOCIATED WITH THE PHACOEMULSIFICATION AND ENDOSCOPIC CYCLOPHOTOCOAGULATION (ECP) PROCEDURE, HOWEVER THE STENT MAY HAVE CONTRIBUTED. REPORTEDLY, THE PATIENT WAS REFERRED TO A RETINA SPECIALIST, AND TREATED WITH MEDICATION WITH THE (CME) RESOLVED BY POSTOP YEAR ONE (1). ANY OMITTED INFORMATION WAS NOT PROVIDED THROUGH FOLLOW-UP. PLEASE SEE THE ATTACHED ARTICLE FOR FURTHER DETAILS. RE

  Patient problems: Macular Edema

  MAUDE report 18041315 ↗
• InjuryOct 31, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED THROUGH A REVIEW OF THE ARTICLE TITLED "COMPARING OUTCOMES OF PHACOEMULSIFICATION AND ENDOCYCLOPHOTOCOAGULATION WITH EITHER DUAL BLADE GONIOTOMY (PECK) OR TWO TRABECULAR STENTS (ICE2)." REPORTED, FOLLOWING CATARACT PLUS TRABECULAR MICROBYPASS STENT PROCEDURES IN A TOTAL OF FORTY-TWO (42) PATIENTS, ONE (1) PATIENT PRESENTED POSTOP WITH A PERSISTENT HYPHEMA BEYOND THREE (3) MONTHS IN THE LEFT OPERATIVE EYE (OS), AND ONE (1) PATIENT PRESENTED WITH CYSTOID MACULAR EDEMA (CME) IN THE RIGHT OPERATIVE EYE (OD). THROUGH FOLLOW-UP, THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED. PER REPORT, THERE WAS NO MEDICAL OR SURGICAL INTERVENTION REQUIRED TO TREAT THE CASE OF HYPHEMA, WHICH RESOLVED BY POSTOP MONTH SIX (6). PER REPORT, THE CASE OF CYSTOID MACULAR EDEMA (CME) WAS "MORE LIKELY" ASSOCIATED WITH THE PHACOEMULSIFICATION AND ENDOSCOPIC CYCLOPHOTOCOAGULATION (ECP) PROCEDURE, HOWEVER THE STENT MAY HAVE CONTRIBUTED. REPORTEDLY, THE PATIENT WAS REFERRED TO A RETINA SPECIALIST, AND TREATED WITH MEDICATION WITH THE (CME) RESOLVED BY POSTOP YEAR ONE (1). ANY OMITTED INFORMATION WAS NOT PROVIDED THROUGH FOLLOW-UP. PLEASE SEE THE ATTACHED ARTICLE FOR FURTHER DETAILS. RE

  Patient problems: Hyphema

  MAUDE report 18041154 ↗
• MalfunctionNov 18, 2020Malposition of Device; Malposition of Device

  IT WAS REPORTED THAT DURING A CATARACT PLUS TRABECULAR MICRO BYPASS STENT SYSTEM PROCEDURE, THE SURGEON IMPLANTED ONE (1) OF THE TWO (2) STENTS IN AN ¿INCORRECT SPOT¿. THE STENT PROCEDURE WAS ABORTED WITH NO REPORT OF PATIENT¿S INJURY. PER REPORT, SURGICAL TECHNIQUE AND EXPERIENCE WITH THE DEVICE CONTRIBUTED TO THE REPORTED EVENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 10865257 ↗
• MalfunctionOct 6, 2020Malposition of Device; Malposition of Device

  IT WAS REPORTED THAT FOLLOWING A RIGHT EYE CATARACT SURGERY, ONE (1) OF TWO (2) STENTS FROM THE TRABECULAR MICRO BYPASS STENT SYSTEM WAS INADVERTENTLY IMPLANTED ANTERIORLY TO THE TRABECULAR MESHWORK (TM) DUE TO PATIENT MOVEMENT. A BACK-UP DEVICE WAS USED TO COMPLETE THE PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 10635898 ↗
• InjuryOct 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOLLOWING A CATARACT PLUS TRABECULAR MICRO BYPASS STENT SYSTEM PROCEDURE, THE PATIENT PRESENTED WITH HYPHEMA AT POSTOP DAY ONE (1). PER REPORT, THE HYPHEMA IMPROVED WITHIN A WEEK, BUT RECURRED THE FOLLOWING WEEK. THE SURGEON CONFERRED WITH GLAUKOS MEDICAL MONITOR WHO REPORTED THAT THE HYPHEMA WAS IMPROVING AND ON IOP MEDICATION WITH HYPHEMA RESOLVING. TREATMENT OPTIONS INCLUDING WAYS TO MONITOR THE PATIENT WERE DISCUSSED. THROUGH FOLLOW-UP, THE SURGEON PROVIDED THE FOLLOWING ADDITIONAL INFORMATION. THE LEFT EYE PROCEDURE WAS UNEVENTFUL, AND THE POSTOP HYPHEMA WAS ASSOCIATED WITH IOP INCREASE (TEMPORARY) WHICH WAS MANAGED WITH GLAUCOMA MEDICATION. THE REPORTED HYPHEMA WAS CHARACTERIZED AS GRADE 1 (LESS THAN OR EQUAL TO 1/3 AC VOL.) PER REPORT, THE PATIENT WAS ON ANTICOAGULANTS PREOPERATIVELY. THE PATIENT¿S MOST RECENT STATUS WAS REPORTED AS ¿DOING WELL ONE (1) AT ONE (1) MONTH POSTOP WITH ADVERSE EVENT RESOLVED¿.

  Patient problems: Hyphema; Intraocular Pressure Increased

  MAUDE report 10619882 ↗
• MalfunctionSep 17, 2020Malposition of Device; Malposition of Device

  IT WAS REPORTED THAT FOLLOWING A LEFT EYE CATARACT SURGERY, THE SURGEON WAS UNABLE TO IMPLANT ONE (1) OF THE TWO (2) STENTS FROM A TRABECULAR MICRO BYPASS STENT SYSTEM. ONE (1) STENT WAS IMPLANTED DEEP IN THE CILIARY BODY, AND THE SURGEON WAS UNABLE TO REMOVE IT INTRAOPERATIVELY. A BACK-UP DEVICE WAS USED TO IMPLANT TWO (2) ADDITIONAL STENTS. PER REPORT, SURGICAL TECHNIQUE/EXPERIENCE WITH DEVICE CONTRIBUTED TO THE REPORTED EVENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 10550175 ↗
• MalfunctionAug 21, 2020Malposition of Device; Malposition of Device

  THROUGH FOLLOW-UP, THE SURGEON REPORTED THE FOLLOWING ADDITIONAL INFORMATION. REPORTEDLY, POOR VISUALIZATION AS A RESULT OF INTRAOPERATIVE TRANSIENT BLEEDING CONTRIBUTED TO THE STENT MALPOSITIONING IN THE PATIENT¿S RIGHT EYE. PER REPORT, THE STENT COULD NOT BE VISUALIZED POSTOPERATIVELY, AND THE STENT POSITIONING DID NOT RESULT IN ANY ADVERSE EVENT. THE PATIENT¿S CURRENT STATUS WAS REPORTED AS ¿VERY ADVANCED GLAUCOMA ON BOTH EYES (OU)¿ WITH ADVERSE RESOLVED.

  Patient problems: Foreign Body In Patient

  MAUDE report 10439937 ↗
• MalfunctionJun 24, 2020Malposition of Device; Malposition of Device

  THROUGH FOLLOW-UP, THE FOLLOWING ADDITIONAL INFORMATION WAS PROVIDED. REPORTEDLY, THE STENT POSITIONING DID NOT RESULT IN ANY ADVERSE IMPACT AND THERE WAS NO SECONDARY SURGICAL INTERVENTION REQUIRED. PER REPORT, THE PATIENT UNDERWENT A SECOND CATARACT PROCEDURE, AND A YAG CAPSULOTOMY WAS PERFORMED ON (B)(6) 2020 (UNRELATED TO THE STENT). THE PATIENT¿S PROGNOSIS WAS REPORTED AS ¿EVENT RESOLVED¿.

  Patient problems: Foreign Body In Patient

  MAUDE report 10192986 ↗
• MalfunctionJun 15, 2020Firing Problem

  PATIENT SCHEDULED FOR CATARACT AND I-STENT SURGERY. THE EXTRACAPSULAR CATARACT EXTRACTION WAS COMPLETED AND THE GLAUKOS ISTENT INJECT PROCEDURE STARTED SOON AFTER. THE ISTENT DEVICE ONLY FIRED ONCE WHEN IT WAS SUPPOSED TO HAVE THREE FIRES IN IT. ANOTHER ISTENT WAS OPENED AND USED IN A SUCCESSFUL PROCEDURE. THE PATIENT WAS SENT BACK TO SAME DAY SURGERY AREA.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10152846 ↗
• InjuryFeb 12, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THROUGH FOLLOW-UP, THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED. THE PATIENT¿S MOST CURRENT PROGNOSIS WAS REPORTED AS ¿GOOD WITH HYPHEMA CLEARED AND THE ADVERSE EVENT RESOLVED¿.

  Patient problems: Hyphema; Intraocular Pressure Increased; Visual Impairment

  MAUDE report 9703219 ↗
• InjuryFeb 5, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT TEN (10) WEEKS FOLLOWING A CATARACT PLUS TRABECULAR MICRO BYPASS STENT SYSTEM PROCEDURE, THE SURGEON OBSERVED DISPLACEMENT OF THE DEVICE. IT WAS NOTED THAT A SECOND SURGERY WAS PERFORMED TO REMOVE THE DISLODGED STENT. ANY OMITTED INFORMATION WAS NOT AVAILABLE AT THE TIME OF THIS REPORT. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT HAS NOT BEEN RECEIVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9672481 ↗
• InjuryJan 15, 2020Adverse 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 SYSTEM, THE PATIENT PRESENTED WITH POST-OPERATIVE HYPHEMA. THROUGH FOLLOW-UP, THE SURGEON REPORTED THAT THE PROCEDURE WAS UNEVENTFUL. THE REPORTED HYPHEMA WAS CHARACTERIZED GRADED AS GRADE I (LESS THAN OR EQUAL TO 1/3 OF THE ANTERIOR CHAMBER VOLUME) WHICH WAS ASSOCIATED WITH IOP INCREASE AND DECREASED VISION. THE PATIENT WAS TREATED WITH STEROIDS AND GLAUCOMA DROPS FOR ONE (1) WEEK. THE MOST RECENT STATUS WAS REPORTED AS ¿RESOLVED AND DROPS WILL BE DISCONTINUED¿. REPORTEDLY, THE PATIENT WAS NOT ON ANY ANTICOAGULANTS. ACCORDING TO THE SURGEON, THE PATIENT¿S MOVEMENT WITH DAILY ACTIVITIES (POSTOPERATIVE) LIKELY CONTRIBUTED TO THE REPORTED EVENT.

  Patient problems: Hyphema; Intraocular Pressure Increased; Visual Impairment

  MAUDE report 9592708 ↗
• InjuryJan 6, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOLLOWING UNEVENTFUL RIGHT EYE CATARACT PLUS TRABECULAR MICRO BYPASS STENT SYSTEM PROCEDURE, THE PATIENT PRESENTED ON POST-OP DAY ONE (1) WITH ENDOPHTHALMITIS ASSOCIATED WITH DECREASED VISUAL ACUITY. PER REPORT, THE PATIENT WAS REFERRED TO A SPECIALIST. THE REPORT NOTED THAT THE FACILITY'S STERILIZER WAS NOT WORKING AT THE TIME, AND THE FACILITY WAS "FLASHING ALL REUSABLE SURGICAL INSTRUMENTS." ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Endophthalmitis; Visual Impairment

  MAUDE report 9555681 ↗
• InjuryJan 6, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THROUGH FOLLOW-UP THE SURGEON PROVIDED THE FOLLOWING ADDITIONAL INFORMATION. THE HYPHEMA WAS CHARACTERIZED AS GRADE I (LESS THAN OR EQUAL TO 1/3 ANTERIOR CHAMBER VOLUME) THE ANTERIOR CHAMBER (AC) WAS FULL OF SUSPENDED RED BLOOD CELLS (RBCS) CAUSING INCREASED INTRA-OCULAR PRESSURE (IOP) ASSOCIATED WITH HAND MOTION VISION. ANTERIOR CHAMBER (AC) WASHOUT WAS PERFORMED AND THE REPORTED EVENT RESOLVED. THE PATIENT STATUS WAS REPORTED AS "DOING GREAT."

  Patient problems: Hyphema; Intraocular Pressure Increased; Visual Impairment

  MAUDE report 9555587 ↗
• MalfunctionDec 20, 2019Malposition of Device; Malposition of Device

  THROUGH FOLLOW-UP THE SURGEON PROVIDED THE FOLLOWING ADDITIONAL INFORMATION. THE PATIENT UNDERWENT A RIGHT EYE CATARACT PLUS STENT PROCEDURE. DURING POSTOP EXAMINATION, ONE (1) STENT APPEARED VISIBLE IN THE CILIARY BODY AND THE OTHER TWO STENTS IMPLANTED IN THE TRABECULAR MESHWORK (TM). ACCORDING TO THE SURGEON, LACK OF PIGMENTATION OF THE ANGLE STRUCTURES AND MILD CORNEAL EDEMA LIMITING THE INTRAOPERATIVE VIEW CONTRIBUTED TO THE STENT MALPOSITIONING. THE STENT POSITIONING WILL BE MONITORED AND THERE IS NO REPORT OF PLANNED INTERVENTION (MEDICAL OR SURGICAL). PER REPORT, THE PATIENT PRESENTED ON POST-OP DAY ONE (1) WITH HYPHEMA WHICH RESOLVED WITHIN A WEEK WITHOUT MEDICAL OR SURGICAL INTERVENTION. THE PATIENT MOST RECENT STATUS WAS REPORTED AS ¿DOING WELL WITH ADVERSE EVENT RESOLVED¿.

  Patient problems: Foreign Body In Patient

  MAUDE report 9500572 ↗
• InjuryDec 5, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS INITIALLY REPORTED BY A TRABECULAR MICRO BYPASS STENT SYSTEM PATIENT. REPORTEDLY, FOLLOWING A RIGHT EYE CATARACT PLUS STENT PROCEDURE, THE SURGEON WAS UNABLE TO LOCATE ONE (1) OF THE TWO (2) STENTS POSTOPERATIVELY. PER PATIENT, THE SURGEON INITIALLY BELIEVED THAT ONE THE STENT WAS IMPLANTED DEEP AND COULD NOT BE VISUALIZED. THROUGH FOLLOW-UP, THE PATIENT REPORTED POSTOPERATIVE ¿HIGH PRESSURE, POOR VISION, ACHING EYE WITH SWOLLEN FACE SENSATION¿ ON THE RIGHT SIDE. DURING A FOLLOW-UP EXAMINATION, THE IMPLANTING SURGEON CLARIFIED THAT ONE (1) OF THE TWO (2) STENTS WAS NOT SUFFICIENTLY IMBEDDED INTRAOPERATIVELY, AND COULD HAD BEEN DISPLACED DURING INTRAOCULAR LENS (IOL) PLACEMENT. ANY OMITTED INFORMATION WAS NOT PROVIDED AT THE TIME OF THIS REPORT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Intraocular Pressure Increased; Pain; Visual Impairment

  MAUDE report 9419003 ↗
• InjurySep 10, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED FOLLOWING BILATERAL CATARACT PLUS TRABECULAR MICRO BYPASS STENT SYSTEM PROCEDURES ONE WEEK APART, THE PATIENT PRESENTED WITH ELEVATED IOP IN BOTH EYES POSTOPERATIVELY. PER REPORT, THE STENTS WERE OBSERVED WELL-POSITIONED IN THE TRABECULAR MESHWORK (TM) AND DIAMOX WAS PRESCRIBED TO TREAT THE IOP ELEVATIONS. THROUGH FOLLOW-UP, THE SURGEON PROVIDED THE FOLLOWING ADDITIONAL INFORMATION. THE PATIENT UNDERWENT UNEVENTFUL BILATERAL CATARACT PLUS STENT IMPLANTATION. THE IOP WAS TREATED WITH DIAMOX (500 MG BID) AND THE IOP IMPROVED. THE ADVERSE EVENT WAS REPORTED TO HAVE RESOLVED. THIS REPORT REFERENCES THE LEFT EYE.

  Patient problems: Intraocular Pressure Increased

  MAUDE report 8984454 ↗
• InjurySep 10, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED FOLLOWING BILATERAL CATARACT PLUS TRABECULAR MICRO BYPASS STENT SYSTEM PROCEDURES ONE WEEK APART, THE PATIENT PRESENTED WITH ELEVATED IOP IN BOTH EYES POSTOPERATIVELY. PER REPORT, THE STENTS WERE OBSERVED WELL-POSITIONED IN THE TRABECULAR MESHWORK (TM) AND DIAMOX WAS PRESCRIBED TO TREAT THE IOP ELEVATIONS. THROUGH FOLLOW-UP, THE SURGEON PROVIDED THE FOLLOWING ADDITIONAL INFORMATION. THE PATIENT UNDERWENT UNEVENTFUL BILATERAL CATARACT PLUS STENT IMPLANTATION. THE IOP WAS TREATED WITH DIAMOX (500 MG BID) AND THE IOP IMPROVED. THE ADVERSE EVENT WAS REPORTED TO HAVE RESOLVED.

  Patient problems: Intraocular Pressure Increased

  MAUDE report 8984440 ↗
• InjuryJun 3, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOLLOWING A LEFT EYE CATARACT PROCEDURE, THE SURGEON WAS UNABLE TO IMPLANT ONE (1) OF THE TWO (2) STENTS FROM A TRABECULAR MICRO BYPASS STENT SYSTEM. ON POSTOP DAY SIX (6), THE PATIENT PRESENTED WITH ENDOPHTHALMITIS. ADDITIONAL INFORMATION IS BEING REQUESTED.

  Patient problems: Endophthalmitis; Hypopyon; Loss of Vision

  MAUDE report 8665030 ↗
• MalfunctionMay 28, 2019Malposition of Device; Malposition of Device

  THROUGH FOLLOW-UP, THE SURGEON REPORTED THE FOLLOWING ADDITIONAL INFORMATION. REPORTEDLY, THE FIRST STENT WAS PLACED SUCCESSFULLY IN THE TRABECULAR MESHWORK (TM), BUT THE SURGEON WAS UNABLE TO PLACE THE SECOND STENT SUCCESSFULLY. THE SURGEON USED A BACK-UP DEVICE TO IMPLANT THE SECOND STENT SUCCESSFULLY IN THE TM. THE POSITIONING OF THE STENT THAT WAS PLACED POSTERIORLY DID NOT RESULT IN ANY ADVERSE IMPACT, AND THE PATIENT WAS BEING MONITORED. THE PATIENT MOST RECENT STATUS WAS REPORTED AS ¿EXCELLENT WITH ADVERSE EVENT RESOLVED¿.

  Patient problems: Foreign Body In Patient

  MAUDE report 8648198 ↗
• InjuryMay 28, 2019Malposition of Device; Malposition of Device

  REPORTEDLY, THE STENT PROCEDURE WAS ABORTED DUE TO POOR VISUALIZATION (INTRAOPERATIVE BLEED) AS A RESULT OF IRIS TRAUMA SECONDARY TO PATIENT MOVEMENT DURING SURGERY. THE SURGEON CHARACTERIZED THE IRIS DAMAGE AS A TWO O¿CLOCK (2.00) TRIVIAL/INCONSEQUENTIAL DAMAGE REQUIRING NO INTERVENTION. THE PATIENT PROGNOSIS WAS REPORTED AS ¿GOOD WITH ADVERSE EVENT RESOLVED¿.

  Patient problems: Eye Injury; Foreign Body In Patient

  MAUDE report 8647448 ↗
• InjuryMay 22, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS INITIALLY REPORTED THAT FOLLOWING A LEFT EYE CATARACT PROCEDURE, THE TRABECULAR MICRO BYPASS STENT SYSTEM PROCEDURE WAS ABORTED DUE TO COMPROMISED VISIBILITY INTRAOPERATIVELY. THROUGH FOLLOW-UP, THE SURGEON REPORTED THAT THE STENT PROCEDURE WAS ABORTED DUE TO IRIS PROLAPSE DURING INSERTION INTO THE EYE WHICH CAUSED BLEEDING. A SECONDARY SURGICAL INTERVENTION WAS PERFORMED TO REMOVE CLOT AND HEME DUE TO ELEVATED IOP. REPORTEDLY, PATIENT STATUS APPEARED TO BE IMPROVING.

  Patient problems: Hyphema; Intraocular Pressure Increased

  MAUDE report 8633741 ↗
• InjuryApr 10, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THROUGH FOLLOW UP THE ADDITIONAL INFORMATION WAS PROVIDED. POSTOPERATIVELY, THE STENT COULD NOT BE VISUALIZED DUE TO HYPHEMA CLOT. THE HYPHEMA WAS CHARACTERIZED AS GRADE II (1/3-1/2 ANTERIOR CHAMBER VOL.) WHICH REQUIRED AN ANTERIOR CHAMBER WASHOUT. THE DISLODGED STENT WAS EXPLANTED AND REPLACED WITH A NEW STENT. THE STENT POSITIONING DID NOT RESULT IN ANY ADVERSE IMPACT TO THE PATIENT. THE PATIENT WAS REPORTED AS ¿STABLE, GOOD PROGNOSIS WITH RESOLVED ADVERSE EVENT¿.

  Patient problems: Hyphema

  MAUDE report 8501941 ↗
• MalfunctionApr 10, 2019No Apparent Adverse Event; No Apparent Adverse Event

  THROUGH FOLLOW-UP, THE SURGEON PROVIDED THE FOLLOWING ADDITIONAL INFORMATION. THERE WAS NO ADVERSE IMPACT TO THE PATIENT, AND THE PATIENT WAS CONTINUING THE GLAUCOMA MEDICATION FOR TARGET IOP.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8500434 ↗