G-Probe™ Illuminate Single 16200-1Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00813125015701), received between Jan 10, 2020 and Nov 5, 2025 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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.

• MalfunctionNov 5, 2025Output above Specifications; Output above Specifications

  IT WAS REPORTED THAT A PATIENT EXPERIENCED A CONJUCTIVAL BURN AFTER 10 IMPACTS WITH A G PROBE ILLUMINATE RFID.

  Patient problems: Eye Injury

  MAUDE report 23483065 ↗
• InjuryJan 10, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IRIDEX RECEIVED A REPORT OF A PATIENT INJURY INVOLVING A SCLERAL BURN. THE BURN OCCURRED DURING A TREATMENT WITH THE G-PROBE ILLUMINATE DEVICE IN CONJUNCTION WITH A CYCLO G6 LASER CONSOLE.

  Patient problems: Radiation Burn

  MAUDE report 9578470 ↗