Eagle 420840010Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 07290018686027), received between Feb 22, 2025 and Jun 4, 2025 — classified as 4 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (2 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 4, 2025Failure to Power Up; Failure to Power Up

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN DIRECT SELECTIVE LASER TRABECULOPLASTY TREATMENT SYSTEM HAS SHUT DOWN TWICE WITHOUT USER INPUT AND THE PROCEDURE WAS ABORTED. THE DOCTOR DID NOT DO A RETREAT AFTER IT WAS ABORTED NOT EVEN HALF. THE SYSTEM WAS CALIBRATED AND YES IT WAS SUCCESSFUL. IT ABORTED DURING A TREATMENT.

  Patient problems: Insufficient Information

  MAUDE report 22141017 ↗
• MalfunctionMar 17, 2025Use of Device Problem; Improper or Incorrect Procedure or Method; Insufficient Device Problem Information; Use of Device Problem; Improper or Incorrect Procedure or Method; Insufficient Device Problem Information

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING A LASER TRABECULOPLASTY PROCEDURE THE SURGEON PERFORMED PROCEDURE ON THE WRONG EYE. 194.5MJ TOTAL ENERGY, 119 OUT OF 120 SHOTS DELIVERED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 21620265 ↗
• MalfunctionFeb 24, 2025Energy Output Problem; Use of Device Problem; Energy Output Problem; Use of Device Problem

  A PHYSICIAN REPORTED ABOUT ABORTED TREATMENT AT 83 OF 120 SHOTS DURING THE PROCEDURE. THIS OCCURRED WHEN TREATMENT WAS COMPLETED ON RIGHT EYE AND STARTED ON LEFT EYE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 21445668 ↗
• InjuryFeb 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN REPORTED THAT AFTER DIRECT SELECTIVE LASER TRABECULOPLASTY PROCEDURE, THE PATIENT EXPERIENCED UNEXPECTED INCREASE IN INTRAOCULAR PRESSURE. ADDITIONAL INFORMATION WAS REQUESTED. THERE ARE FOUR MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS REPORT. THIS IS 4 OF 4.

  Patient problems: Insufficient Information; Intraocular Pressure Increased

  MAUDE report 21440715 ↗
• InjuryFeb 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN REPORTED THAT AFTER DIRECT SELECTIVE LASER TRABECULOPLASTY PROCEDURE, THE PATIENT EXPERIENCED UNEXPECTED INCREASE IN INTRAOCULAR PRESSURE. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED STATING THAT THE PATIENT HAD SPIKE IN POST OPERATIVE IOP AND ADDITIONALLY PATIENT HAD BILATERAL IRITIS. THE PATIENT WAS STARTED TREATMENT WITH DIURETIC AND CARBONIC ANHYDRASE INHIBITOR TWICE A DAY, CORTICOSTEROIDS ONCE A DAY AND THEN TWICE A DAY FOR ONE WEEK. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE LEFT EYE.

  Patient problems: Intraocular Pressure Increased; Iritis

  MAUDE report 21440714 ↗
• InjuryFeb 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN REPORTED THAT AFTER DIRECT SELECTIVE LASER TRABECULOPLASTY PROCEDURE, THE PATIENT EXPERIENCED UNEXPECTED INCREASE IN INTRAOCULAR PRESSURE. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED STATING THAT THE PATIENT HAD SPIKE IN POST OPERATIVE IOP AND ADDITIONALLY PATIENT HAD BILATERAL IRITIS. THE PATIENT WAS STARTED TREATMENT WITH DIURETIC AND CARBONIC ANHYDRASE INHIBITOR TWICE A DAY, CORTICOSTEROIDS ONCE A DAY AND THEN TWICE A DAY FOR ONE WEEK. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE RIGHT EYE.

  Patient problems: Intraocular Pressure Increased; Iritis

  MAUDE report 21440713 ↗
• InjuryFeb 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN REPORTED THAT AFTER DIRECT SELECTIVE LASER TRABECULOPLASTY PROCEDURE, THE PATIENT EXPERIENCED UNEXPECTED INCREASE IN INTRAOCULAR PRESSURE (IOP). ADDITIONAL INFORMATION WAS RECEIVED AS SPIKE IN IOP AND PATIENT UNDERGO WITH TREATMENT MEDICATIONS. THERE ARE FOUR MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS REPORT. THIS IS 3 OF 4.

  Patient problems: Intraocular Pressure Increased

  MAUDE report 21440712 ↗