TRAB(TM)360 Trabeculotomy System FG 03706Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00858027006112), received between Mar 24, 2017 and Sep 21, 2017 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Detachment Of Device Component” (1 report).

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

• MalfunctionSep 21, 2017Detachment Of Device Component; Improper or Incorrect Procedure or Method; Device Dislodged or Dislocated; Detachment Of Device Component; Improper or Incorrect Procedure or Method

  THE SURGEON REPORTED SEVERING THE TRABECULOTOME WHILE PERFORMING A TRABECULOTOMY. THE SEVERED PORTION OF THE DEVICE WAS LODGED IN SCHLEMM'S CANAL. THE ENTIRE DEVICE WAS REMOVED FROM THE EYE. THERE IS NO KNOWN ADVERSE IMPACT TO THE PATIENT.

  Patient problems: Foreign Body In Patient; No Known Impact Or Consequence To Patient

  MAUDE report 6883741 ↗
• MalfunctionMar 24, 2017Use of Device Problem; Detachment of Device or Device Component; Use of Device Problem; Detachment of Device or Device Component

  THE SURGEON REPORTED SEVERING THE TIP OF THE TRABECULOTOME WHILE PERFORMING A TRABECULOTOMY. THE ENTIRE DEVICE WAS REMOVED FROM THE EYE WITHOUT INCIDENT. A NEW DEVICE WAS SUCCESSFULLY USED TO COMPLETE THE CASE. THE EVENT DID NOT RESULT IN ANY ADVERSE IMPACT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6433193 ↗