G-Probe™ Single 11256-1Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00851089000234), received between May 5, 2017 and May 23, 2023 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryMay 23, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IRIDEX BECAME AWARE OF A PATIENT EXPERIENCING CONJUNCTIVAL BURN DURING TREATMENT WITH A G-PROBE. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED, AND NO ADDITIONAL INFORMATION HAS BEEN PROVIDED BY THE CLINIC OR TREATING PHYSICIAN. ENGINEERING FAILURE ANALYSIS COULD NOT BE PERFORMED BECAUSE THE DEVICE WAS NOT RETURNED FOR EVALUATION. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS MOMENT. IRIDEX WILL CONTINUE TO FOLLOW-UP WITH THE DOCTOR FOR INFORMATION REGARDING PATIENT RECOVERY.

  Patient problems: Eye Burn

  MAUDE report 16989274 ↗
• InjuryJun 17, 2022Output Problem

  IRIDEX BECAME AWARE OF A PATIENT EXPERIENCING SCLERAL PERFORATION DURING TREATMENT USING A G-PROBE AND CYCLO G6 LASER SYSTEM BASED ON THE INFORMATION PROVIDED, IT APPEARS THE TREATMENT WAS PERFORMED WITHIN SPECIFICATIONS. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. FOLLOW UP EMAILS WITH THE CLINIC HAS CONFIRMED THAT NO LASER MALFUNCTION WAS OBSERVED DURING THE PROCEDURE. THE TREATING PHYSICIAN DID NOT OBSERVE ANY CONTAMINATION AT THE TIP OF THE DEVICE AND CONFIRMED THE ABSENCE OF PIGMENTATION IN THE EYE PRIOR TO THE PROCEDURE. ENGINEERING FAILURE ANALYSIS HAS NOT YET BEEN PERFORMED BECAUSE THE RETURNED PROBE HAS NOT BEEN RECEIVED. FAILURE ANALYSIS WILL BE COMPLETED ONCE THE PROBE IS RECEIVED. IF NEW INFORMATION BECOMES AVAILABLE, THIS RECORD WILL BE AMENDED. THE RESULTS OF POST MARKET DATA REVIEW INDICATE THAT THIS FAILURE MODE IS NOT OCCURRING WITH GREATER SEVERITY OR FREQUENCY BASED ON THE NUMBER OF EVENTS REPORTED EVALUATED AGAINST THE NUMBER OF CASES PERFORMED.

  Patient problems: Perforation

  MAUDE report 14739021 ↗
• MalfunctionApr 1, 2019Off-Label Use; Off-Label Use

  PER REPORT, 0500170000-2019-8006, RECEIVED AT IRIDEX FROM FDA: "THE PHYSICIAN REPORTED THAT THE LASER DID NOT APPEAR TO BE WORKING. THE PHYSICIAN REPORTED THAT THE LASER MISFIRED AFTER A NEW G PROBE WAS CONNECTED. THE PROCEDURE WAS DISCONTINUED AND THE PATIENT WAS NOT HARMED".

  Patient problems: No Information

  MAUDE report 8471836 ↗
• InjuryMay 5, 2017Device Operates Differently Than Expected

  PHYSICIAN BEGAN USING A DIODE LASER WITH A G PROBE. HE STATED THAT THE PROBE BURNED THE EYE. PHYSICIAN REQUESTED ANOTHER G PROBE AND IT WORKED CORRECTLY WITH NO PROBLEMS. AFTER THE PROCEDURE PHYSICIAN REQUESTED DRUGS/EYE DROPS TO TREAT THE BURNED AREA OF THE EYE. AN EYE PATCH AND EYE SHIELD WAS APPLIED TO THE EYE.

  Patient problems: Eye Burn

  MAUDE report 6553886 ↗