iTrack 250ARecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00893872001059), received between May 9, 2019 and Jun 16, 2023 — classified as 2 injuries.

The most frequently reported specific device problem is “Material Twisted/Bent” (1 report).

1 FDA recall record name this device's identifier.

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.

Recalls naming this device

1. Jan 11, 2018Terminated

   Sterility failure found in one of the units in the lot.

   Z-0011-2019 · Root cause: Process control · FDA record ↗

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJun 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CYCLODIALYSIS CLEFT FORMATION DURING CANALOPLASTY WITH ITRACK 250A MICROCATHETER. CLEFT REPAIR WAS CARRIED ON THE SAME DAY AS A PRECAUTION TO PREVENT HYPOTONY. AN MVR BLADE WAS USED TO MAKE THE GONIOTOMY. DURING INITIAL INTUBATION OF THE SCHLEMMS CANAL WITH THE MICROCATHETER AN OBSTRUCTION WAS ENCOUNTERED WITHIN 1 CLOCK HOUR OF THE GONIOTOMY. THE SURGEON APPLIED ADDITIONAL PRESSURE TO THE MICROCATHETER WITH MICROFORCEPS, THE OBSTRUCTION COULD NOT BE BY-PASSED, HOWEVER THIS RESULTED IN A KINK IN THE MICROCATHETER AND A 1 CLOCK HOUR CYCLODIALYSIS CLEFT. SUBSEQUENTLY AN ATTEMPT WAS MADE TO INTUBATE SCHLEMMS CANAL WITH THE SAME MICROCATHETER FROM THE OPPOSITE DIRECTION. THE MICROCATHETER WENT INTO THE CYCLODIALYSIS CLEFT AND NOT SCHLEMMS CANAL. THE SURGEON THEN ABANDONED THE CANALOPLASTY, PERFORMED A CATARACT REMOVAL AND REPAIRED THE CLEFT. THE SURGEON NOTED THAT THE MVR BLADE COULD HAVE CAUSED A DEEPER OPENING IN THE WALL OF THE SCHLEMMS CANAL, LEADING TO INCREASED LIKELIHOOD OF CLEFT FORMATION.

  Patient problems: Eye Injury

  MAUDE report 17141061 ↗
• InjuryMay 9, 2019Material Twisted/Bent; Material Twisted/Bent

  THIS IS A FOLLOW-UP REPORT . THE PATIENT HAS HAD PERSISTENT INFLAMMATORY DEBRIS AND WILL LIKELY UNDERGO A VITRECTOMY TO REMOVE THE MATERIAL. THIS REPORT IS MADE BY ELLEX ISCIENCE WITHOUT PREJUDICE AND DOES NOT IMPLY ANY ADMISSION OF LIABILITY FOR THE INCIDENT OR ITS CONSEQUENCES.

  Patient problems: Inflammation

  MAUDE report 8597977 ↗