G-Probe™ Illuminate Box of 6 16000Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00813125015350), received between Feb 3, 2022 and Jun 18, 2022 — classified as 2 injuries.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (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.

• InjuryJun 18, 2022Patient-Device Incompatibility

  IRIDEX BECAME AWARE OF A COMPLAINT REPORTING A PATIENT EXPERIENCING MULTIPLE CONJUNCTIVAL BURNS DURING TREATMENT WITH THE G-PROBE. A SPECIFIC ROOT CAUSE COULD NOT BE DETERMINED. BASED ON SIMILAR REPORTED EVENTS, THE MOST LIKELY CAUSE OF THE ISSUE IS SUSPECTED TO BE CONTAMINATION (E.G. BLOOD, TISSUE OR BETADINE) ON THE PROBE TIP WHEN THE LASER WAS ACTIVATED OR LASER ACTIVATION WHEN THE PROBE IS OVER PIGMENTED CONJUNCTIVAL TISSUE. THE IS NO ADDITIONAL INFORMATION AVAILABLE AT THIS TIME. ENGINEERING FAILURE ANALYSIS WAS NOT PERFORMED BECAUSE THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE G-PROBE IFU HAS CLEAR INSTRUCTIONS TO EXAMINE THE PROBE TIP BEFORE TREATMENT AND TO AVOID AREAS OF PERILIMBAL PIGMENTATION. PER THE IFU 'EXCESSIVE TREATMENT POWER MAY RESULT IN OCULAR SURFACE BURNS OR CILIARY BODY HEMORRHAGE. CONTAMINATION OF THE FIBER OPTIC TIP BY BLOOD OR TISSUE CHAR MAY RESULT IN OCULAR SURFACE BURNS. EXCESSIVE ENERGY MAY CAUSE EQUATORIAL BURNS. HEAVY PERILIMBAL CONJUNCTIVAL PIGMENTATION MAY RESULT IN LOCAL ABSORPTION AND BURNS; THEREFORE, AVOID AREAS OF HEAVY PERILIMBAL PIGMENTATION.' IF THE DEVICES ARE RETURNED AND THE RESULTS OF FAILURE ANALYSIS INDICATE NEW INFORMATION, THE AD

  Patient problems: Eye Burn

  MAUDE report 14740054 ↗
• InjuryFeb 3, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IRIDEX BECAME AWARE OF A COMPLAINT REPORTING 3 SCLERAL BURNS FOLLOWING TREATMENT WITH SLX LASER CONSOLE AND G-PROBE DELIVERY DEVICE. MINIMAL INFORMATION WAS PROVIDED BY THE CUSTOMER WITH RESPECT TO POTENTIAL CAUSES OF THE EVENTS OR THE PERFORMANCE OF THE LASER CONSOLE AND THE DELIVERY DEVICE. THE CUSTOMER CALL RECORD INDICATED THAT THE FOLLOWING TREATMENT PARAMETERS WERE USED 1250MW, 2000MS. NO OTHER INFORMATION WAS PROVIDED WITH THE CALL RECORD. THE DEVICES HAVE NOT BEEN RETURNED FOR EVALUATION. THE CUSTOMER HAS NOT RESPONDED TO REQUEST FOR ADDITIONAL INFORMATION. IRIDEX WILL CONTINUE TO FOLLOW UP AND ATTEMPT TO GET ADDITIONAL INFORMATION RELATED TO THE EVENT. AT THIS TIME, IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE OF THE ISSUE AND IT IS NOT KNOWN IF THE SCLERAL BURNS REPORTED AFFECTED A SINGLE PATIENT OR MULTIPLE PATIENTS. AN AMENDED REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Superficial (First Degree) Burn

  MAUDE report 13446775 ↗