iTrack Advance iTrack-ADSRecalls & reported problems

Summary

The FDA's MAUDE database contains 53 adverse event reports that list this exact device (DI 00893872001622), received between Apr 22, 2024 and May 1, 2026 — classified as 43 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (30 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 53 reports, in the reporter's own words as published by the FDA.

• InjuryMay 1, 2026Adverse Event Without Identified Device or Use Problem

  DESCEMET'S DETACHMENT OCCURRED DURING ITRACK ADVANCE PROCEDURE. THE DESCEMETS DETACHMENT WAS NEAR THE INTUBATION SITE AND TRAVELED INTO VA. THE SURGEON MADE VENTING INCISIONS IN ATTEMPT TO REMOVE RETAINED OVD AND HEME. A PERIPHERAL POCKET OF DETACHMENT APPEARED TO REATTACH (CONFIRMED BY TISSUE STRIAE) BUT CENTRALLY MAY NOT HAVE.

  Patient problems: Eye Injury

  MAUDE report 25053882 ↗
• InjuryApr 13, 2026Adverse Event Without Identified Device or Use Problem

  DESCEMET'S DETACHMENT OCCURRED DURING ITRACK ADVANCE PROCEDURE. THE SURGEON REMOVED SOME OVD FROM BENEATH THE DETACHED TISSUE.

  Patient problems: Eye Injury

  MAUDE report 24854112 ↗
• InjuryMar 30, 2026Adverse Event Without Identified Device or Use Problem

  DESCEMET'S DETACHMENT OCCURRED DURING SURGERY WITH THE ITRACK ADVANCE. THE DESCEMET'S DETACHMENT WAS SUCCESSFULLY ADDRESSED USING AN AIR BUBBLE REPAIR.

  Patient problems: Eye Injury

  MAUDE report 24708812 ↗
• InjuryFeb 3, 2026Adverse Event Without Identified Device or Use Problem

  A SMALL DESCEMET'S DETACHMENT OCCURRED DURING ITRACK ADVANCE PROCEDURE WHICH WAS REPAIRED USING THE STAB AND STEAMROLL TECHNIQUE.

  Patient problems: Eye Injury

  MAUDE report 24254222 ↗
• InjuryJun 10, 2025Off-Label Use; Off-Label Use

  IRIDODIALYSIS OCCURRED DURING ITRACK ADVANCE CANALOPLASTY AND GATT PROCEDURE FOR A PATIENT WITH NVG AND PAS. FOLLOWING THE CANALOPLASTY WITH THE ITRACK ADVANCE, MST FORCEPS WERE USED TO GRASP THE TIP OF THE MICROCATHETER WHICH WAS THEN WITHDRAWN TO ACHIEVE A 360-DEGREE GATT. UPON COMPLETION OF THE SURGERY, AN IRIDODIALYSIS CLEFT OF APPROXIMATELY 3 CLOCK HOURS WAS OBSERVED. THE IRIDODIALYSIS WAS REPAIRED USING 10-0 PROLENE.

  Patient problems: Eye Injury

  MAUDE report 22173284 ↗
• InjuryMar 24, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  DURING RETRACTING OF THE CATHETER DURING VISCODILATION, A SECTION OF THE OUTER SHEATH OF THE ITRACK ADVANCE CATHETER BROKE AND REMAINED INSIDE SCHLEMM'S CANAL. THIS WAS REMOVED BY THE SURGEON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21684829 ↗
• InjuryFeb 5, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  THE ITRACK ADVANCE CATHETER OUTER SHEATH SEVERED DURING USE, THE SURGEON COMPLETED THE CASE AND RETRIEVED THE SEVERED PART OF CATHETER FROM SCHLEMM'S CANAL COMPLETING CASE WITH NOTED ISSUE OF OTOMY LARGER THAN SURGEON WANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21318758 ↗
• InjuryDec 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A 90 PERCENT DESCEMET'S DETACHMENT OCCURRED DURING ABIC OUT WITH ITRACK ADVANCE. DURING THE PROCEDURE THE CATHETER WAS EGRESSING PROVISC OVD ON ITS OWN AFTER THE SURGICAL TECHNICIAN INITIALLY DEMONSTRATED WHAT HAPPENS WHEN THE CATHETER WAS PUMPED WITH A LARGE ALIQUOT OF PROVISC. NO ADDITIONAL CLICKS OF OVD WERE ADMINISTERED DURING THE PROCEDURE. THE CANNULA WAS USED INTUBATE SCHLEMM'S CANAL 360 DEGREES AND THEN A 180-DEGREE GONIOTOMY WAS PERFORMED.

  Patient problems: Eye Injury

  MAUDE report 20922022 ↗
• InjuryDec 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A DESCEMET'S TEAR OCCURRED FROM A PARACENTESIS SITE TO THE VISUAL AXIS. AN AIR BUBBLE WAS PLACED IN THE EYE TO COMPRESS AND HOLD THE CORNEAL LAYERS TOGETHER FOR PROPER HEALING.

  Patient problems: Eye Injury

  MAUDE report 20921720 ↗
• InjuryDec 12, 2024Retraction Problem; Detachment of Device or Device Component; Retraction Problem; Detachment of Device or Device Component

  ITRACK ADVANCE DEVICE WAS INSPECTED BEFORE ENTERING THE EYE AND CONFIRMED AS WORKED CORRECTLY. AFTER CANNULATING 360 DEGREES, THE SURGEON STARTED RETRACTING THE CATHETER. AROUND 180 DEGREES THEY NOTICED THAT IT WOULD NOT RETRACT ANY FURTHER. AT THAT POINT IT SEPARATED, AND THE CATHETER HAD TO BE WITHDRAWN FROM THE EYE WITH A PAIR OF MST FORCEPS. THE SURGEON DELIVERED 180 DEGREES OF VISCOELASTIC BEFORE THE SEPARATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20920415 ↗
• InjuryDec 12, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  THE ITRACK ADVANCE CATHETER CAME APART DURING USE, LEAVING FRAGMENTS IN THE PATIENT'S EYE. THESE WERE RETRIEVED USING INTRAOCULAR FORCEPS TO REMOVE THE REMAINING FRAGMENTS FROM SCHLEMM'S CANAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20920173 ↗
• InjuryDec 12, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  THE ITRACK ADVANCE CATHETER CAME APART DURING USE, LEAVING FRAGMENTS IN THE PATIENT'S EYE. THESE WERE RETRIEVED USING INTRAOCULAR FORCEPS TO REMOVE THE REMAINING FRAGMENTS FROM SCHLEMM'S CANAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20919984 ↗
• InjuryDec 12, 2024Retraction Problem; Detachment of Device or Device Component; Retraction Problem; Detachment of Device or Device Component

  UNCOMPLICATED CE/ABIC WITH ITRACK ADVANCE (NO TRABECULOTOMY). THE INSERTION AND INITIAL CIRCUMNAVIGATION WAS SMOOTH WITHOUT ANY INTRACANALICULAR OBSTRUCTIONS. WHILE WITHDRAWING AND VISCODILATING, THE SLIDING MECHANISM STOPPED AND THE WITHDRAWAL SEEMED TO HALT. THIS WAS AFTER ABOUT 4-5 CLOCK HOURS. THEN, IT SUDDENLY RELEASED WITH AN AUDIBLE AND TACTILE SNAP. THE SURGEON WITHDREW THE MICROCATHETER, NOTING THE CATHETER SHEATH HAD SNAPPED OFF RELATIVELY CLOSE TO THE HUB AND THE BLACK GUIDEWIRE WAS VISIBLE. THE REMAINDER OF THE OUTER SHEATH WAS RETAINED IN THE CANAL. THE SURGEON RETRIEVED THIS USING MICROFORCEPS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20919412 ↗
• InjuryNov 12, 2024Retraction Problem; Detachment of Device or Device Component; Retraction Problem; Detachment of Device or Device Component

  THE ITRACK ADVANCE CATHETER WAS DEPLOYED AND THEN RETRACTED OUTSIDE THE EYE,PRIOR TO THE PROCEDURE TO ENSURE IT WORKED. UPON ENTERING THE EYE, THE SURGEON CANULATED 180 DEGREES AND MET RESISTANCE. THE SURGEON ATTEMPTED TO RETRACT THE CATHETER, BUT IT WOULD NOT RETRACT. THE CATHETER THEN BROKE OFF AND BECAME LODGED IN THE EYE. THE SURGEON RETRIEVED THE PIECE OF CATHETER WITH A PAIR OF FORCEPS AND ABORTED THE PROCEDURE THEN USED AN ALTERNATIVE PRODUCT TO TREAT THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20670512 ↗
• MalfunctionOct 31, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  UPON OPENING THE ITRACK ADVANCE CATHETER, THE CATHETER WOULD NOT ADVANCE AND APPEARED TO KINK AND THEN BECAME SEPARATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20584482 ↗
• InjuryOct 22, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  360-DEGREE INTUBATION OF THE ITRACK ADVANCE AND OVD DELIVERY UPON RETRACTION WAS COMPLETED. WHEN THE DEVICE WAS REMOVED FROM THE EYE THE SURGEON NOTICED THAT MOST OF THE CATHETER WAS STILL IN SCHLEMM'S CANAL. THE SURGEON REMOVED THE CATHETER WITH MICRO GRASPERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20511381 ↗
• InjuryOct 22, 2024Material Fragmentation; Material Fragmentation

  POST-OP, THE PATIENTS' IOP SPIKED AND AN AC WASHOUT AND IMPLANT REMOVAL WAS CARRIED OUT. WHEN THE HIGH IOP PERSISTED, A DRAINAGE DEVICE WAS IMPLANTED. ON THE DAY OF THIS IMPLANT PROCEDURE, A SMALL PIECE OF THE ITRACK ADVANCE CATHETER SHEATH MATERIAL WAS NOTICED BY THE SURGEON AT THE OTOMY SITE AND REMOVED.

  Patient problems: Foreign Body In Patient; Intraocular Pressure Increased

  MAUDE report 20502450 ↗
• InjuryOct 22, 2024Material Fragmentation; Material Fragmentation

  360-DEGREE INTUBATION OF THE ITRACK ADVANCE AND OVD DELIVERY UPON RETRACTION WAS COMPLETED. WHEN THE DEVICE WAS REMOVED FROM THE EYE THE SURGEON NOTICED THAT A SMALL PIECE OF THE CATHETER WAS STILL IN SCHLEMM'S CANAL. THE SURGEON REMOVED THE CATHETER PIECE WITH MICRO GRASPERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20502384 ↗
• InjuryOct 17, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  THE ITRACK ADVANCE BROKE DURING USE AND THE OUTER SHEATH OF THE CATHETER REQUIRED EXTRACTION FROM SCHLEMM'S CANAL USING MST FORCEPS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20478191 ↗
• InjuryOct 15, 2024Retraction Problem; Detachment of Device or Device Component; Retraction Problem; Detachment of Device or Device Component

  DURING CANALOPLASTY WITH THE ITRACK ADVANCE, THE SURGEON INTUBATED SCHLEMMS CANAL 360 DEGREES. SUBSEQUENT DELIVERY OF OVD AND RETRACTION WAS NOT POSSIBLE, THE SURGEON WAS UNABLE TO RETRACT THE CATHETER. ON THE SECOND ATTEMPT AT RETRACTION, THE CATHETER BROKE. MST FORCEPS WERE USED TO RETRIEVE THE SEVERED SECTION OF THE CATHETER WHICH REMAINED IN THE PATIENTS EYE. A PARTIAL GONIOTOMY WAS REQUIRED. THE SURGEON WAS UNABLE TO IMPLANT THE STENT IN THE REMAINING TRABECULAR MESHWORK. STENT IMPLANTATION WAS ORIGINALLY PLANNED FOR POST-CANALOPLASTY TREATMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20448103 ↗
• InjuryOct 10, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  DURING AN ITRACK ADVANCE PROCEDURE, DURING OVD DELIVERY AND CATHETER WITHDRAWAL, THE CATHETER BROKE INSIDE SCHLEMM'S AND REQUIRED EXTRACTION BY THE SURGEON USING FORCEPS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20424971 ↗
• InjuryOct 8, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  DURING AN ITRACK ADVANCE PROCEDURE, WHEN THE CATHETER WAS BEING RETRACTED, THE CATHETER SHEATH SEPARATED FROM THE MAIN DEVICE. THE SURGEON COMPLETED EXTRACTION OF THE BROKEN PIECE FROM THE PATIENTS EYE INTRAOPERATIVELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20403929 ↗
• InjurySep 27, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  THE OUTER SHEATH OF THE ITRACK ADVANCE CATHETER SEPARATED FROM THE MAIN DEVICE DURING USE. THE SURGEON PERFORMED AN UNPLANNED GONIOTOMY TO REMOVE THE SEPARATED MATERIAL FROM SCHLEMM'S CANAL. THE SURGEON INVERTEDLY GRABBED THE IRIS WITH THE FORCEPS WHILE DOING SO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20318048 ↗
• InjurySep 26, 2024Material Separation; Detachment of Device or Device Component; Material Separation; Detachment of Device or Device Component

  DURING RETRACTION AND VISCODILATION, THE ITRACK ADVANCE CATHETER STARTED STRIPPING I.E.: TEARING OF OUTER SHEATH OCCURRED. PARTS OF THE OUTER TUBING DETACHED DURING THE PROCEDURE AND WERE REMOVED WITH FORCEPS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20307778 ↗
• MalfunctionSep 20, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  CATHETER BROKE NEAR THE SPATULATED TIP DURING THE GATT PROCEDURE USING ITRACK ADVANCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20273609 ↗