iStent inject W G2-WRecalls & reported problems

Summary

The FDA's MAUDE database contains 97 adverse event reports that list this exact device (DI 00853704002319), received between Nov 10, 2020 and May 22, 2026 — classified as 30 injuries, 67 malfunctions.

The most frequently reported specific device problem is “Break” (43 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 25 most recent of 97 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 22, 2026Break

  IT WAS REPORTED THAT DURING THE IMPLANTATION OF THE STENTS FROM A TRABECULAR MICROBYPASS STENT SYSTEM, THE TROCAR BROKE OFF IN THE ANTERIOR CHAMBER (AC). PER REPORT, THE SURGEON COMPLETED THE PROCEDURE, AND RETRIEVED THE TROCAR FRAGMENT INTRAOPERATIVELY WITHOUT PATIENT INJURY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25257142 ↗
• MalfunctionDec 1, 2025Break; Break

  IT WAS REPORTED THAT THE TROCAR BROKE DURING A TRABECULAR MICROBYPASS STENT SYSTEM PROCEDURE, AND THE FRAGMENT WAS OBSERVED IN THE ANGLE. PER REPORT, THE SURGEON BELIEVES THE FRAGMENT WAS SUCCESSFULLY REMOVED INTRAOPERATIVELY FROM THE PATIENT'S EYE DURING IRRIGATION AND ASPIRATION WITH NO REPORT OF ADVERSE PATIENT IMPACT. REPORTEDLY, THE PROCEDURE WAS COMPLETED USING A BACK-UP DEVICE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23688450 ↗
• MalfunctionNov 20, 2025Malposition of Device; Malposition of Device

  IT WAS REPORTED THAT FOLLOWING A CATARACT SURGERY AND THE IMPLANTATION OF THE FIRST STENT (OF TWO STENTS) FROM A TRABECULAR MICROBYPASS STENT SYSTEM, THE SURGEON ATTEMPTED TO DEPLOY THE SECOND STENT BUT NOTICED THAT THE FIRST STENT HAD MOVED FROM IT'S IMPLANTED LOCATION. PER REPORT, THE SECOND STENT WAS NOT DEPLOYED IN THE EYE, AND A BACK-UP DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE REPORT NOTED THAT NO STENTS WERE REMOVED FROM THE EYE INTRAOPERATIVELY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 23606668 ↗
• InjuryOct 7, 2025Break; Malposition of Device; Break; Malposition of Device

  IT WAS REPORTED THAT FOLLOWING A CATARACT SURGERY, DURING THE IMPLANTATION OF THE SECOND STENT (OF TWO (2) STENTS) FROM A TRABECULAR MICRO BYPASS STENT SYSTEM, THE TIP OF THE TROCAR BROKE. PER REPORT, THE FRAGMENT WAS REMOVED INTRAOPERATIVELY WITH NO PATIENT INJURY, AND TWO (2) STENTS WERE IMPLANTED. HOWEVER, THE SURGEON OBSERVED THAT THE SECOND STENT MAY NOT BE SEATED PROPERLY AND APPEARS TO BE IN THE LOWER PART OF THE TRABECULAR MESHWORK (TM). THE REPORT NOTED THAT THE PATIENT IS BEING MONITORED, AND THE SURGEON IS SEEKING COUNSEL AND A MEDICAL EXPERT CONSULTATION WAS OFFERED. THROUGH FOLLOW-UP, THE SURGEON CONFERRED WITH A MEDICAL EXPERT WHO REPORTED DISCUSSING SURGICAL TECHNIQUES, AND POSSIBLE REASONS FOR THE TROCAR BREAK. THE REPORT REITERATED THAT THE SURGEON WAS ABLE TO SUCCESSFULLY REMOVE THE TROCAR FRAGMENT FROM THE PATIENT'S EYE WITH NO SEQUELAE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Corneal Edema; Foreign Body In Patient; Hyphema; Intraocular Pressure Increased; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23240873 ↗
• MalfunctionApr 29, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT FOLLOWING A RIGHT EYE (OD) CATARACT SURGERY PLUS TRABECULAR MICROBYPASS STENT SYSTEM PROCEDURE, THE PATIENT PRESENTED APPROXIMATELY THREE (3) YEARS AND THREE (3) MONTHS POSTOPERATIVELY DURING A SLIT LAMP EXAMINATION WITH A DISLODGED STENT SITTING IN THE INFERIOR ANGLE. THE REPORT NOTED THAT THE PATIENT IS NOT EXPERIENCING ANY COMPLICATIONS DUE TO THE DISLODGED STENT. PER REPORT, THE SURGEON IS SEEKING COUNSEL ON TREATMENT OPTIONS, AND A CONSULTATION WITH A MEDICAL EXPERT WAS OFFERED. THROUGH FOLLOW-UP, THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED. PER REPORT, THE PATIENT UNDERWENT AN UNEVENTFUL CATARACT SURGERY FOLLOWED BY STENT IMPLANTATION, AND REITERATED THAT THERE WAS NO ADVERSE PATIENT IMPACT. REPORTEDLY, THE EVENT IS ONGOING WITH THE PATIENT STABLE AND CONTINUING TO BE MONITORED WITHOUT INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21931031 ↗
• MalfunctionMar 17, 2025Malposition of Device; Malposition of Device

  IT WAS REPORTED THAT FOLLOWING A TRABECULAR MICROBYPASS STENT SYSTEM PROCEDURE, ONE (1) OF TWO (2) STENTS WAS OBSERVED "TOO POSTERIOR". THROUGH FOLLOW UP, IT WAS REPORTED THAT THE STENT WAS BELIEVED TO BE IMPLANTED IN THE SUPRACHOROIDAL SPACE, THOUGH NOT CERTAIN. PER REPORT, THE SURGEON WAS STRUGGLING WITH VISUALIZATION OF THE ANGLE AND TRABECULAR MESHWORK (TM) AND REPORTED DIFFICULTY IMPLANTING THE STENTS (INITIALLY AIMING TOO POSTERIOR). THE SURGEON WAS ABLE TO IMPLANT ONE (1) OF TWO (2) STENTS. A SECOND DEVICE WAS OPENED TO IMPLANT AN ADDITIONAL STENT, HOWEVER THE SURGEON WAS UNABLE TO IMPLANT ANY OF THE STENTS FROM THE SECOND DEVICE. SUBSEQUENTLY, A THIRD DEVICE WAS USED TO IMPLANT A SECOND STENT AND COMPLETED THE PROCEDURE. FOLLOW UP WAS REQUESTED, AND ON (B)(6)2025, THE FOLLOWING WAS REPORTED. THE POSTERIOR STENT REMAINED IMPLANTED AND WAS CONFIRMED TO BE IN PLACE. THE SURGEON WAS CONTENT TO LEAVE AS IS. ADDITIONAL FOLLOW UP WAS REQUESTED, AND ON (B)(6) 2025, THE FOLLOWING WAS REPORTED. THE STENT WAS BELIEVED TO BE IMPLANTED IN THE SUPRACHOROIDAL SPACE BUT IS NOT CERTAIN AS THERE WAS "IRIS PROCESSES" IN THE WAY. REPORTEDLY, THE PATIENT IS "DOING WELL" WITH THE ANTERIOR CHAMB

  Patient problems: Foreign Body In Patient

  MAUDE report 21627283 ↗
• InjuryFeb 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOLLOWING BILATERAL TRABECULAR MICROBYPASS STENT PROCEDURES, THE PATIENT PRESENTED POSTOPERATIVELY WITH INTERMITTENT BLURRED VISUAL ACUITY (OU), DESCRIBED AS "SEVERE" AND "NON-SERIOUS", WITH THE EPISODE OF BLURRED VISION LASTING A FEW SECONDS BEFORE RESOLVING. PER REPORT, THE PATIENT WAS REFERRED TO A RETINA SPECIALIST AND TO CARDIOLOGY, AND THE RESULTS ARE PENDING. ADDITIONALLY PER REPORT, THE PATIENT PRESENTED WITH POSTERIOR VITREOUS DEGENERATION IN THE LEFT EYE (OS), WHICH WAS DESCRIBED AS "MILD" AND "NON-SERIOUS" WITH NO REPORTED INTERVENTION. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THIS REPORT REFERENCES THE CASE OF BLURRED VISUAL ACUITY AND POSTERIOR VITREOUS DEGENERATION ASSOCIATED WITH THE LEFT EYE (OS).

  Patient problems: Visual Impairment; Vitreous Detachment

  MAUDE report 21406773 ↗
• MalfunctionFeb 13, 2025Break; Break

  IT WAS REPORTED THAT FOLLOWING A CATARACT SURGERY, THE TIP OF THE TROCAR BROKE DURING THE IMPLANTATION OF THE SECOND STENT FROM A TRABECULAR MICROBYPASS STENT SYSTEM. THE TROCAR FRAGMENT WAS REMOVED INTRAOPERATIVELY FROM THE PATIENT'S EYE WITH NO REPORT OF INJURY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21379730 ↗
• MalfunctionFeb 5, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT FOLLOWING A LEFT EYE (OS) CATARACT PLUS TRABECULAR MICROBYPASS STENT SYSTEM PROCEDURE, A GONIOSCOPE EXAMINATION ON POSTOP DAY THREE (3) IDENTIFIED A DISLODGED STENT SITTING IN THE ANTERIOR ANGLE OF THE PATIENT'S EYE WITH NO ASSOCIATED REPORT OF PATIENT INJURY. PER REPORT, THE SURGEON IS SEEKING COUNSEL TO MANAGE THE DISLODGED STENT, AND A MEDICAL EXPERT CONSULTATION HAS BEEN OFFERED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21316069 ↗
• MalfunctionSep 18, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT FOLLOWING A LEFT EYE (OS) CATARACT SURGERY, DURING ATTEMPT TO IMPLANT THE STENTS FROM A TRABECULAR MICROBYPASS STENT SYSTEM, ONE (1) STENT DISLODGED INTRAOPERATIVELY FOLLOWING THE REMOVAL OF VISCOELASTIC AND WAS SUBSEQUENTLY REMOVED FROM THE EYE DURING INJECTION/ASPIRATION (IA). AT ONE (1) WEEK POSTOP, THE PATIENT PRESENTED WITH THE REMAINING STENT VISUALIZED IN THE INFERIOR ANGLE. DURING THE PATIENT'S TWO (2) WEEK POSTOP EXAMINATION IT WAS NOTED THAT THE STENT REMAINED IN THE INFERIOR ANGLE WITHOUT INFLAMMATION IN THE ANTERIOR CHAMBER (AC). PER REPORT, THE SURGEON WAS SEEKING COUNSEL REGARDING THE REPORTED EVENT. THROUGH FOLLOW-UP, THE SURGEON CONSULTED WITH A MEDICAL EXPERT WHO REPORTED DISCUSSING WAYS TO MANAGE A DISLODGED STENT BASED ON THE POSITIONING OF THE STENT POSTOPERATIVELY, AND ADDITIONAL TREATMENT OPTIONS TO MANAGE THE PATIENT'S GLAUCOMA WERE ALSO DISCUSSED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20251335 ↗
• 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-W DEVICE IN THE RIGHT EYE (OD).

  Patient problems: Adhesion(s)

  MAUDE report 20242008 ↗
• InjuryMay 22, 2024Adverse 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, THERE WAS NO ADVERSE EFFECT ON THE NURSE, NO FURTHER INTERVENTION REQUIRED AND THE EVENT RESOLVED. THE REPORT NOTED THE EVENT WAS "BY ACCIDENT".

  Patient problems: Needle Stick/Puncture

  MAUDE report 19378262 ↗
• InjuryMay 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOLLOWING A TRABECULAR MICROBYPASS STENT SYSTEM PROCEDURE, THE PATIENT PRESENTED ONE AND ONE HALF (1.5) YEARS POSTOP WITH DECREASED INTRAOCULAR PRESSURE, CHARACTERIZED AS "MILD" AND "NON-SERIOUS", WHICH RESOLVED WITHOUT INTERVENTION. ANY OMITTED INFORMATION WAS NOT AVAILABLE AT THE TIME OF REPORT.

  Patient problems: Intraocular Pressure Decreased

  MAUDE report 19367904 ↗
• InjuryMay 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOLLOWING A TRABECULAR MICROBYPASS STENT SYSTEM PROCEDURE, THE PATIENT PRESENTED APPROXIMATELY ONE (1) YEAR POSTOP WITH DECREASED INTRAOCULAR PRESSURE (IOP), CHARACTERIZED AS "MILD" AND "NON-SERIOUS", WHICH RESOLVED WITHOUT TREATMENT. ANY OMITTED INFORMATION WAS NOT AVAILABLE AT THE TIME OF REPORT.

  Patient problems: Intraocular Pressure Decreased

  MAUDE report 19365790 ↗
• MalfunctionMay 21, 2024Malposition of Device; Malposition of Device

  IT WAS REPORTED THAT THE SURGEON INADVERTENTLY MISPOSITIONED THE FIRST STENT (OF TWO STENTS) FROM A TRABECULAR MICROBYPASS STENT SYSTEM, AND SUBSEQUENTLY WAS UNABLE TO VISUALIZE THE STENT DURING ATTEMPT TO RETRIEVE THE MISPOSITIONED STENT. PER REPORT, A BACK-UP DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE REPORT NOTED THAT SURGICAL TECHNIQUE CONTRIBUTED TO THE EVENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 19361300 ↗
• MalfunctionFeb 15, 2024Malposition of Device; Malposition of Device

  IT WAS REPORTED THAT FOLLOWING A CATARACT SURGERY, THE FIRST STENT (OF TWO STENTS) WAS UNDER-IMPLANTED AND SUBSEQUENTLY UNABLE TO BE VISUALIZED INTRAOPERATIVELY DURING THE IMPLANTATION OF THE SECOND STENT. PER REPORT, A BACK-UP DEVICE WAS USED TO IMPLANT AN ADDITIONAL STENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 18713190 ↗
• MalfunctionFeb 9, 2024Malposition of Device; Malposition of Device

  IT WAS REPORTED THAT FOLLOWING AN UNSUCCESSFUL ATTEMPT TO IMPLANT THE SECOND STENT FROM A TRABECULAR MICROBYPASS STENT SYSTEM AND SUBSEQUENT IMPLANT OF AN ADDITIONAL STENT FROM A BACK-UP DEVICE, A FREE FLOATING STENT WAS OBSERVED BEHIND THE LENS. PER REPORT, THE SURGEON CHOSE TO LEAVE THE FREE FLOATING STENT IN THE OPERATIVE EYE, AND THE PROCEDURE WAS COMPLETED WITH A TOTAL OF TWO (2) STENTS IMPLANTED. ADDITIONAL INFORMATION IS BEING REQUESTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 18677867 ↗
• InjuryNov 8, 2023Break; Break

  IT WAS REPORTED THAT DURING THE IMPLANTATION OF THE SECOND STENT FROM A TRABECULAR MICROBYPASS STENT SYSTEM, THE PATIENT MOVED AND A SMALL CYCLODIALYSIS CLEFT WAS SUBSEQUENTLY FORMED IN THE OPERATIVE EYE. PER REPORT, THE SURGEON REMOVED BOTH STENTS INTRAOPERATIVELY. SUBSEQUENTLY DURING A POSTOP EXAMINATION, THE SURGEON THOUGHT HE SAW "SOMETHING IN THE CLEFT" AND IS UNSURE IF THERE MAY BE A STENT OR TROCAR FRAGMENT REMAINING IN THE EYE. ADDITIONAL INFORMATION HAS B EEN REQUESTED.

  Patient problems: Eye Injury

  MAUDE report 18097495 ↗
• InjuryOct 31, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED. PER REPORT, A FOLLOW-UP RIGHT EYE (OD) VISUAL FIELD EXAMINATION WAS PERFORMED ON (B)(6) 2023.

  Patient problems: Visual Impairment

  MAUDE report 18040780 ↗
• InjurySep 25, 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) CATARACT SURGERY, THE SURGEON INADVERTENTLY PUNCTURED THE IRIS DURING ATTEMPT TO IMPLANT THE STENT FROM A TRABECULAR MICROBYPASS STENT SYSTEM. REPORTEDLY, EXCESSIVE HEME WAS OBSERVED, AND THE PROCEDURE WAS ABORTED. PER REPORT, THE OPERATIVE EYE "WAS NOT VISIBLE ON THE SCREEN" INTRAOPERATIVELY, WHICH CONTRIBUTED TO THE EVENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Eye Injury; Hyphema

  MAUDE report 17813666 ↗
• MalfunctionAug 28, 2023Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT FOLLOWING A RIGHT EYE (OD) CATARACT PLUS TRABECULAR MICROBYPASS STENT SYSTEM PROCEDURE, THE PATIENT PRESENTED APPROXIMATELY ONE (1) WEEK POSTOP WITH STENT OBSTRUCTION DESCRIBED AS "MILD AND NON-SERIOUS" WITH "THE IRIS PULLED INTO THE STENT LUMEN", OBSERVED DURING A SLIT LAMP EXAMINATION. PER REPORT, THERE WAS NO INTERVENTION PERFORMED AND THE EVENT WAS NOTED AS ONGOING. THE MOST RECENT PATIENT STATUS WAS DESCRIBED AS "INTRAOCULAR PRESSURE (IOP) REMAINS SATISFACTORY WITH THE STENT VISIBLE IN THE ORIGINAL IMPLANT LOCATION" AS OF THE ONE (1) YEAR POSTOP FOLLOW-UP EXAMINATION. ADDITIONAL INFORMATION IS BEING REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17638417 ↗
• InjuryAug 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOLLOWING A LEFT EYE (OS) CATARACT PLUS TRABECULAR MICROBYPASS STENT SYSTEM PROCEDURE, THE PATIENT PRESENTED APPROXIMATELY ONE (1) MONTH POSTOP WITH REBOUND IRITIS DESCRIBED AS "MILD AND NON-SERIOUS", WHICH WAS RESOLVED WITH RESUMPTION OF MEDICATIONS. ANY OMITTED INFORMATION WAS NOT AVAILABLE AT THE TIME OF REPORT.

  Patient problems: Iritis

  MAUDE report 17638298 ↗
• InjuryAug 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOLLOWING A LEFT EYE (OS) CATARACT PLUS TRABECULAR MICROBYPASS STENT SYSTEM PROCEDURE, THE PATIENT PRESENTED APPROXIMATELY ONE (1) MONTH POSTOP WITH IRITIS DESCRIBED AS "MILD AND NON-SERIOUS", WHICH WAS RESOLVED WITH CONTINUATION OF MEDICATION. ANY OMITTED INFORMATION WAS NOT AVAILABLE AT THE TIME OF REPORT.

  Patient problems: Iritis

  MAUDE report 17638292 ↗
• InjuryAug 28, 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) CATARACT PLUS TRABECULAR MICROBYPASS STENT SYSTEM PROCEDURE, THE PATIENT PRESENTED APPROXIMATELY SIX (6) MONTHS POSTOP WITH IRITIS DESCRIBED AS "MILD AND NON-SERIOUS", WHICH WAS RESOLVED WITH MEDICATION. ANY OMITTED INFORMATION WAS NOT AVAILABLE AT THE TIME OF REPORT.

  Patient problems: Iritis

  MAUDE report 17638281 ↗
• InjuryAug 28, 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) CATARACT PLUS TRABECULAR MICROBYPASS STENT SYSTEM PROCEDURE, THE PATIENT PRESENTED APPROXIMATELY TWO AND A HALF (2.5) MONTHS POSTOP WITH PERIPHERAL ANTERIOR SYNECHIAE (PAS) DESCRIBED AS "MILD AND NON-SERIOUS". PER REPORT, THE PAS WAS TREATED WITH MEDICATION WITH "NO POSSIBLE RESOLUTION". THE MOST RECENT FOLLOW-UP EXAMINATION NOTED THE STENT WAS VISIBLE IN THE ORIGINAL IMPLANT LOCATION. ADDITIONAL INFORMATION IS BEING REQUESTED.

  Patient problems: Adhesion(s)

  MAUDE report 17638274 ↗