Hydrus® Microstent F00022Recalls & reported problems

Summary

The FDA's MAUDE database contains 276 adverse event reports that list this exact device (DI 00867487000134), received between Oct 29, 2018 and Sep 25, 2026 — classified as 249 injuries, 27 malfunctions.

The most frequently reported specific device problem is “Malposition of Device” (98 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 276 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2026Difficult to Advance

  A non-healthcare professional reported that during a trabecular stent implantation procedure, the stent did not deploy.Additional information was requested but no information is available at the time of this report.

  Patient problems: Insufficient Information

  MAUDE report 50897322 ↗
• MalfunctionSep 24, 2026Separation Failure

  A health care professional reported that during a trabecular stent implantation procedure, the stent was caught and could not be detached.Additional information has been requested but no information is available at the time of this report.

  Patient problems: Insufficient Information

  MAUDE report 50881014 ↗
• MalfunctionSep 21, 2026Separation Failure

  The health care professional reported that the arms did not disengage. The timing of the event was unknown.Additional information has been requested but no information is available at the time of this report.

  Patient problems: Insufficient Information

  MAUDE report 50838308 ↗
• InjurySep 21, 2026Malposition of Device

  A healthcare professional reported via a clinical study that a patient experienced iris inlet adhesions in the left eye following stent implantation. Follow-up information clarified that the event was associated with partial stent-iris touch and intraocular inflammation. Medical treatment was administered, and the inflammation resolved; however, the iris adhesion (synechiae) persisted and could remain unless surgically lysed, although surgical intervention was not considered necessary. The reporter noted no change in intraocular pressure (IOP) and a stable stent, and ongoing monitoring was planned. Iris inlet adhesions, partial stent-iris touch and associated intraocular inflammation were considered related to the stent and not related to the stent implantation procedure or the cataract procedure. No secondary ocular surgical intervention was performed. The inflammation resolved following treatment, while the adhesion/synechiae remained under observation. Onset severity of the inflammation reported as mild.

  Patient problems: Adhesion(s); Eye Injury; Inflammation

  MAUDE report 50838305 ↗
• MalfunctionSep 8, 2026Separation Failure

  A healthcare professional reported that during a trabecular stent implantation procedure, the stent did not exit the injector.Additional information has been requested but is not available at the time of this report.

  Patient problems: Insufficient Information

  MAUDE report 50670190 ↗
• MalfunctionSep 8, 2026Difficult to Advance

  A healthcare professional reported that during a trabecular stent implantation procedure, the stent was jammed and was not able to use.Additional information has been requested but no information is available at the time of this report.

  Patient problems: Insufficient Information

  MAUDE report 50669900 ↗
• InjuryDec 4, 2025Migration; Migration

  A NON-HEALTHCARE PROFESSIONAL HAD REPORTED AFTER TRABECULAR STENT IMPLANTATION SURGERY PATIENT HAD CHOROIDAL FOLDS. BLOOD IN THE CHAMBER HAD PROHIBITED VISUALIZATION, AND ADDITIONAL POSTOPERATIVE CHECKS WERE PERFORMED. INTRAOCULAR PRESSURE HAD SPIKED BUT WAS LATER CONTROLLED WITH DROPS. THE CHOROIDAL FOLDS HAD RESOLVED. THE STENT HAD DIVED. NO HEME HAD BEEN OBSERVED. THE SYMPTOMS WERE RESOLVED.

  Patient problems: Hyphema; Intraocular Pressure Increased; Uveitis

  MAUDE report 23715047 ↗
• InjuryOct 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN REPORTED THAT ONE YEAR AFTER THE STENT IMPLANTATION PROCEDURE, OPTICAL COHERENCE TOMOGRAPHY SHOWED SIGNIFICANT PROGRESSION IN THE RETINAL NERVE FIBER LAYER. THE PATIENT UNDERWENT OCULAR SECONDARY SURGICAL INTERVENTIONS FOR INTRAOCULAR PRESSURE (IOP) OR GLAUCOMA MANAGEMENT IN THE LEFT EYE. DESPITE THESE INTERVENTIONS, IOP AND VISUAL FIELD REMAINED STABLE. A DIRECT SELECTIVE LASER TRABECULOPLASTY HAD BEEN SCHEDULED FOR THE FOLLOWING MONTH. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 23291514 ↗
• InjurySep 9, 2025Malposition of Device; Malposition of Device

  A HEALTHCARE PROFESSIONAL REPORTED THROUGH A CLINICAL STUDY SITE THAT A PATIENT DEVELOPED AN EIGHT-BALL HYPHEMA WITH ELEVATED INTRAOCULAR PRESSURE ON POSTOPERATIVE DAY ONE FOLLOWING A STENT IMPLANTATION PROCEDURE. TO PREVENT CORNEAL BLOOD STAINING, THE PATIENT WAS TAKEN TO THE OPERATING ROOM THE SAME DAY, AND AN ANTERIOR CHAMBER WASHOUT WAS IMMEDIATELY PERFORMED. AT FOLLOW UP DAY AFTER THE WASHOUT, THE PATIENT HAD PERSISTENT POOR VISION BUT SHOWED A MUCH IMPROVED DEGREE OF HYPHEMA. THE PATIENT¿S VISION SUBSEQUENTLY IMPROVED.

  Patient problems: Intraocular Pressure Increased; Visual Impairment

  MAUDE report 23004310 ↗
• MalfunctionJul 10, 2025Migration; Migration

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE STENT IMPLANTATION PROCEDURE, THE STENT WAS SUCCESSFULLY PLACED AFTER THREE ATTEMPTS BY REPOSITIONING. THREE DAYS AFTER IMPLANTATION, THE DEVICE MIGRATED, INDICATING DISLODGEMENT OR MOVEMENT. THERE WAS PARTIAL EXTRUSION OF THE DEVICE HOWEVER, NO CONTACT WITH THE CORNEA OR IRIS WAS OBSERVED. NO INTERVENTION WAS REQUIRED AT THE TIME. THE EVENT RESOLVED WITHOUT SEQUELAE.

  Patient problems: Insufficient Information

  MAUDE report 22468198 ↗
• InjuryMar 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN REPORTED THAT DURING THE POST OPERATIVE WEEK ONE VISIT AFTER THE STENT IMPLANTATION PROCEDURE, THE PATIENT EXPERIENCED BLURRY VISION AND FLOATERS SINCE POST OPERATIVE DAY 5. THE PATIENT HAD DIFFUSE GRANULOMATOUS KERATIC PRECIPITATES (KPS), ANTERIOR CHAMBER AND VITREOUS CELL. THE PHYSICIAN DID TAP AND INJECT JUST TO BE SAFE, BUT CONJUNCTIVA WAS WHITE AND QUIET, NO PAIN, DIDN¿T REALLY SEEM LIKE ENDOPHTHALMITIS. THE PHYSICIAN THOUGHT IT COULD BE EARLY SYMPATHETIC OPHTHALMIA OR REACTION TO STENT (GRANULOMATOUS INFLAMMATORY REACTION). ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED STATING POST-OPERATIVELY, GRANULOMATOUS UVEITIS WAS FIRST NOTED ON POST-OPERATIVE DAY 8, ACCOMPANIED BY WORSENED VISION AND ELEVATED INTRAOCULAR PRESSURE. GIVEN THE PRESENTATION OF ANTERIOR CHAMBER AND VITREOUS CELL WITHIN ONE WEEK OF SURGERY, THE CONDITION HAD INITIALLY BEEN TREATED AS A POSSIBLE CASE OF POST-OPERATIVE ENDOPHTHALMITIS. THE PATIENT UNDERWENT A VITREOUS TAP AND RECEIVED AN INTRAVITREAL INJECTION OF CEPHALOSPORIN ANTIBIOTICS AND GLYCOPEPTIDE ANTIBIOTICS ON THE SAME DAY. THE PATIENT HAD BEEN LAST SEEN ON POST OPERATIVE DAY 14 (LAST SEEN DATE), AT WHICH POINT BACTERIAL CULTURES AND

  Patient problems: Blurred Vision; Intraocular Pressure Increased; Uveitis; Vitreous Floaters

  MAUDE report 21596918 ↗
• InjuryJan 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HEALTHCARE PROFESSIONAL REPORTED VIA STUDY THAT PATIENT EXPERIENCED A PERIPHERAL ANTERIOR SYNECHIAE WITH A MILD SEVERITY AND RE-POSITIONING.

  Patient problems: Adhesion(s)

  MAUDE report 21078323 ↗
• MalfunctionDec 6, 2024Fracture; Fracture

  A FACILITY REPRESENTATIVE REPORTED THAT DURING AN STENT IMPLANTATION PROCEDURE, STENT WAS BROKEN WHILE IT WAS BEING INSERTED. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE PROCEDURE WAS COMPLETED WITH ANOTHER STENT.

  Patient problems: Insufficient Information

  MAUDE report 20863439 ↗
• InjuryNov 29, 2024Malposition of Device; Malposition of Device

  ADDITIONAL INFORMATION STATED THAT WORSENING OF VISUAL FIELD (MEAN DEVIATION GREATER THAN OR EQUAL TO 2.5 DECIBELS (DB) OR MORE CONFIRMED BY 2 REPEAT MEASUREMENTS).

  Patient problems: Insufficient Information; Loss of Vision

  MAUDE report 20810726 ↗
• MalfunctionNov 12, 2024Malposition of Device; Malposition of Device

  A PHYSICIAN REPORTED THAT FOLLOWING AN STENT IMPLANT PROCEDURE, PATIENT HAD INCREASED INTRAOCULAR PRESSURE (IOP) OF 13 OS. ON GONIOSCOPY, THE STENT WAS CLEARLY PLUGGED WITH TENTED-UP IRIS TISSUE COMPLETELY OCCLUDING THE LUMEN OF THE PORTION OF THE STENT EXPOSED IN THE ANTERIOR CHAMBER (AC). ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE LEFT EYE.

  Patient problems: Intraocular Pressure Increased

  MAUDE report 20664832 ↗
• MalfunctionNov 12, 2024Malposition of Device; Malposition of Device

  A PHYSICIAN REPORTED THAT FOLLOWING AN STENT IMPLANT PROCEDURE, PATIENT HAD INCREASED INTRAOCULAR PRESSURE (IOP) OF 19 OD. ON GONIOSCOPY, THE STENT WAS CLEARLY PLUGGED WITH TENTED-UP IRIS TISSUE COMPLETELY OCCLUDING THE LUMEN OF THE PORTION OF THE STENT EXPOSED IN THE ANTERIOR CHAMBER (AC). ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE RIGHT EYE.

  Patient problems: Intraocular Pressure Increased

  MAUDE report 20663702 ↗
• InjuryNov 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN STENT IMPLANT PROCEDURE, THE PATIENT HAD HYPOTONY AND DECREASE VISUAL ACUITY (VA). PATIENT WAS STABLE, OBSERVING MAC AND INTRAOCULAR PRESSURE (IOP). THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS COMPLAINT. THIS REPORT IS 2 OF 2.

  Patient problems: Blurred Vision; Intraocular Pressure Decreased

  MAUDE report 20598625 ↗
• InjuryOct 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HEALTHCARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF THE MICROSTENT IMPLANT SURGERY COMBINED WITH CATARACT SURGERY WAS PERFORMED AND DETACHMENT OF DESCEMETS MEMBRANE OCCURRED. AS PER THE SURGEON, IT IS UNCLEAR WHEN THIS SYMPTOM OCCURRED, BUT THAT THE TIP OF THE MICROSTENT CANNULA MAY HAVE PROBABLY HIT THIS AREA DURING ENGAGEMENT. THERE IS NO SPECIFIC TREATMENT BEING TAKEN FOR THE PATIENT AT THIS TIME. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Eye Injury

  MAUDE report 20570965 ↗
• MalfunctionOct 29, 2024Migration; Migration

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING A GLAUCOMA SHUNT IMPLANT PROCEDURE, THE STENT SEEMED TO HAVE BEEN PLACED WELL. HOWEVER, WHEN IT WAS ADVANCED, IT APPEARED TO "BOUNCE BACK" SLIGHTLY. THE DECISION WAS MADE TO LEAVE IT AS THE STENT SEEMED ADEQUATELY ADVANCED. ON POSTOPERATIVE DAY ONE, THE STENT WAS VISIBLE AT THE SLIT LAMP WITHOUT GONIOSCOPY AND WAS PROTRUDING FROM THE BEGINNING OF THE FIRST WINDOW. THERE WAS NO NOTABLE CONTACT WITH THE IRIS OR CORNEA, AND THE PATIENT OTHERWISE APPEARED STABLE, WITH AN INTRAOCULAR PRESSURE (IOP) OF 7 MMHG. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 20562052 ↗
• InjuryOct 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HEALTH CARE PROFESSIONAL PUBLISHED ORIGINAL ARTICLE WITH A PURPOSE EARLY TO LATE EXPLANTATION OF HYDRUS MICROSTENT MIGS DEVICE: A CASE SERIES. THE HYDRUS MICROS TENT WAS APPROVED BY THE FDA IN (B)(6) 2018 FOR USE WITH CATARACT SURGERY TO REDUCE IOP IN PATIENTS WITH MILD TO MODERATE PRIMARY OPEN ANGLE GLAUCOMA (POAG). PIVOTAL CLINICAL TRIALS DEMONSTRATED ITS OVERALL SAFETY AND EFFICACY IN LOWERING IOP. HOWEVER, MISPOSITIONING OF THE IMPLANT CAN RESULT IN UVEITIS GLAUCOMA- HYPHEMIA (UGH) SYNDROME NECESSITATING DEVICE EXPLANTATION. HERE WE REPORT FOUR SUCH CASES AND THEIR ASSOCIATED CHALLENGES. WE ALSO HIGHLIGHT THE IMPORTANCE OF EARLY RECOGNITION OF POST-OPERATIVE COMPLICATIONS FOR EASE OF IMPLANT REMOVAL. A 71-YEAR-OLD MAN WITH POAG ON DUAL ANTI-PLATELET THERAPY (ASPIRIN AND CLOPIDOGREL) PRESENTED WITH PERSISTENT HYPHEMA AND UNCONTROLLED IOP AFTER THE HYDRUS IMPLANT. DURING HIS CATARACT AND HYDRUS IMPLANT SURGERY, SIGNIFICANT BLEEDING WAS NOTED FROM THE INITIAL GONIOTOMY SITE FOR HYDRUS INSERTION, AND ADDITIONAL VISCOELASTIC WAS ABLE TO TAMPONADE THE BLEED INTRAOPERATIVELY. IN THE POST-OPERATIVE PERIOD, THE PATIENT DEVELOPED A LARGE HYPHEMA AND NASAL CLOT WITH AN IOP OF 64 MMHG AN

  Patient problems: Adhesion(s); Intraocular Pressure Increased; UGH (Uveitis Glaucoma Hyphema) Syndrome

  MAUDE report 20415701 ↗
• InjuryOct 9, 2024Malposition of Device; Malposition of Device

  A HEALTH CARE PROFESSIONAL PUBLISHED ORIGINAL ARTICLE WITH A PURPOSE EARLY TO LATE EXPLANTATION OF HYDRUS MICROSTENT MIGS DEVICE: A CASE SERIES. THE HYDRUS MICROS TENT WAS APPROVED BY THE FDA IN AUGUST 2018 FOR USE WITH CATARACT SURGERY TO REDUCE IOP IN PATIENTS WITH MILD TO MODERATE PRIMARY OPEN ANGLE GLAUCOMA (POAG). PIVOTAL CLINICAL TRIALS DEMONSTRATED ITS OVERALL SAFETY AND EFFICACY IN LOWERING IOP. HOWEVER, MISPOSITIONING OF THE IMPLANT CAN RESULT IN UVEITIS GLAUCOMA- HYPHEMIA (UGH) SYNDROME NECESSITATING DEVICE EXPLANTATION. HERE WE REPORT FOUR SUCH CASES AND THEIR ASSOCIATED CHALLENGES. WE ALSO HIGHLIGHT THE IMPORTANCE OF EARLY RECOGNITION OF POST-OPERATIVE COMPLICATIONS FOR EASE OF IMPLANT REMOVAL. A 76-YEAR-OLD MAN WITH POAG PRESENTED WITH CHRONIC GRANULOMATOUS IRITIS AFTER UNCOMPLICATED CATARACT AND HYDRUS IMPLANT SURGERY. THE PROXIMAL END OF THE HYDRUS WAS MALPOSITIONED, BEING NOTED TO PROTRUDE FURTHER INTO THE ANTERIOR CHAMBER THAN DESIRED RATHER THAN LYING CLOSE TO THE TM. STILL, IT WAS JUDGED TO BE IN ACCEPTABLE POSITION GIVEN THAT THERE WAS NO CONTACT WITH THE IRIS AND MORE THAN 2/3 OF THE TRANSITION ZONE WAS COVERED. AT THE POM 1, VISUAL ACUITY WAS 20/25 + 1 WITH AN

  Patient problems: Uveitis

  MAUDE report 20406756 ↗
• InjuryOct 9, 2024Malposition of Device; Malposition of Device

  A HEALTH CARE PROFESSIONAL PUBLISHED ORIGINAL ARTICLE WITH A PURPOSE EARLY TO LATE EXPLANTATION OF HYDRUS MICROSTENT MIGS DEVICE: A CASE SERIES. THE HYDRUS MICROS TENT WAS APPROVED BY THE FDA IN AUGUST 2018 FOR USE WITH CATARACT SURGERY TO REDUCE IOP IN PATIENTS WITH MILD TO MODERATE PRIMARY OPEN ANGLE GLAUCOMA (POAG). PIVOTAL CLINICAL TRIALS DEMONSTRATED ITS OVERALL SAFETY AND EFFICACY IN LOWERING IOP. HOWEVER, MISPOSITIONING OF THE IMPLANT CAN RESULT IN UVEITIS GLAUCOMA- HYPHEMIA (UGH) SYNDROME NECESSITATING DEVICE EXPLANTATION. HERE WE REPORT FOUR SUCH CASES AND THEIR ASSOCIATED CHALLENGES. WE ALSO HIGHLIGHT THE IMPORTANCE OF EARLY RECOGNITION OF POST-OPERATIVE COMPLICATIONS FOR EASE OF IMPLANT REMOVAL. THIS FILE WAS CREATED FOR A 75-YEAR-OLD FEMALE WITH A HISTORY OF BILATERAL CHRONIC ANGLE CLOSURE GLAUCOMA AND AGE-RELATED MACULAR DEGENERATION WAS REFERRED FOR CHRONIC GRANULOMATOUS UVEITIS WITH ELEVATED IOP AFTER CATARACT SURGERY WITH HYDRUS MICROSTENT IMPLANTATION IN THE LEFT EYE 8 MONTHS PRIOR. THE PATIENT COMPLAINED OF NO IMPROVEMENT IN VISION AFTER THE SURGERY AND HAD A HISTORY OF RECURRENT INFLAMMATION ON TAPERING TOPICAL STEROIDS. SHOWED CME WITH A CENTRAL MACULAR THICKNES

  Patient problems: Intraocular Pressure Increased; Macular Edema; Uveitis

  MAUDE report 20406727 ↗
• InjuryOct 4, 2024Defective Device; Defective Device

  A PHYSICIAN REPORTED THAT AFTER GLAUCOMA SHUNT IMPLANTATION PROCEDURE, THERE WAS DETACHMENT OF DESCEMET MEMBRANE. HE REPORTED THAT IT WAS THE FIRST TIME THAT THE SURGEON WAS USING THE MICROSTENT. HE INCISED TRABECULAR MESHWORK WITH THE TIP OF A CANNULA AND INSERTED IT INTO SCHLEMM CANAL. HOWEVER, HE FELT THAT THE CUT WAS DIFFICULT, BECAUSE THE TIP OF THE CANNULA WAS BIGGER THAN HE EXPECTED OR HE FELT THE TIP WAS NOT SHARP BUT DULL; IT WAS TOO DULL TO MAKE AN INCISION. HE CONSIDERS THAT THOSE FACTORS WOULD AFFECT THE DETACHMENT OF DESCEMET MEMBRANE. CURRENTLY THERE HAS BEEN NO TREATMENT PLAN FOR THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS REPORT. THIS IS 2 OF 2.

  Patient problems: Eye Injury

  MAUDE report 20369179 ↗
• InjuryOct 4, 2024Defective Device; Defective Device

  ACCORDING TO THE ADDITIONAL INFORMATION RECEIVED, THE PATIENT HAS BEEN RECOVERING. NO CORNEAL EDEMA OR OTHER CORNEAL EFFECTS HAVE OCCURRED AT THIS TIME. VISUAL ACUITY HAS BEEN ACHIEVED. THE TYPE OF PROCEDURE PERFORMED WAS CATARACT SURGERY + GLAUCOMA SHUNT INSERTION.

  Patient problems: Eye Injury

  MAUDE report 20369047 ↗
• InjurySep 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN REPORTED THAT FOLLOWING AN STUNT IMPLANT PROCEDURE, THE PATIENT HAD INTRAOCULAR PRESSURE (IOP) 60 POST IMPLANT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Intraocular Pressure Increased

  MAUDE report 20322643 ↗