G-Probe™ Short Handle Single 12044-1Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00813125016036), received between Jul 24, 2023 and Sep 14, 2023 — classified as 2 injuries.

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.

• InjurySep 14, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IRIDEX BECAME AWARE OF A COMPLAINT REPORTING A CONJUCTIVAL BURN USING 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 17750586 ↗
• InjuryJul 24, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IRIDEX BECAME AWARE OF A COMPLAINT REPORTING A SCLERAL 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17385523 ↗