G-Probe™ Illuminate Box of 6 16200Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00813125015718), received between Apr 22, 2026 and Apr 22, 2026 — classified as 1 injury.

The most frequently reported specific device problem is “Use of Device Problem” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryApr 22, 2026Use of Device Problem

  IT WAS REPORTED TO IRIDEX THAT WHILE USING THE G-PROBE ILLUMINATE LASER DELIVERY DEVICE, THE PATIENT EXPERIENCED THREE (03) SCLERAL BURNS. NO PERMANENT IMPAIRMENT WAS REPORTED TO IRIDEX, AND NO MEDICAL INTERVENTION ASSOCIATED WITH THE BURN WAS REPORTED TO IRIDEX. THE LOCAL DISTRIBUTOR PROVIDED A REPLACEMENT PROBE TO THE HOSPITAL. THE DEFECTIVE PROBE HAS BEEN RETAINED AND IS PENDING RETURN TO IRIDEX. ALTHOUGH, IT SHOULD BE NOTED THAT PROBES ARE NOT SERVICED BY IRIDEX SINCE THEY ARE SINGLE USE AND IF THE PROBES ARE USED DURING TREATMENT, IT IS RECOMMENDED TO DISPOSE THEM AS THEY BECOME BIOHAZARD. NO ISSUES REGARDING THE LASER CONSOLE BEING USED DURING THE TREATMENT WERE REPORTED TO IRIDEX. THE REPORTED SETTINGS USED FOR TREATMENT WERE CONSISTENT WITH THE IFU (FOUR 20-SECOND PASSES PER HEMISPHERE; POWER: 1500 MV). NO PERMANENT IMPAIRMENT WAS REPORTED TO IRIDEX, AND NO MEDICAL INTERVENTION ASSOCIATED WITH THE BURN WAS REPORTED TO IRIDEX. ALSO, IT WAS REPORTED THAT THE PROBE TIP WAS BURNED WHEN CHECKED UNDER THE MICROSCOPE. AS PER THE IFU, FOLLOWING ARE THE RECOMMENDATIONS FOR TREATMENT PURPOSE - "KEEP THE G-PROBE ILLUMINATE TIP CLEAN TO MINIMIZE THE RISK OF BURNS TO THE OCULAR SURFACE.

  Patient problems: Eye Injury

  MAUDE report 24960750 ↗