G-Probe™ Box of 6 11256Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00851089000227), received between May 5, 2026 and May 5, 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.

• InjuryMay 5, 2026Use of Device Problem

  IRIDEX RECEIVED A ADVERSE EVENT REPORT INVOLVING A IRIDEX CYCLO G6 AND A G-PROBE DELIVERY DEVICE. AS PER THE REPORT, DURING CILIARY BODY DESTRUCTION USING TSCPC IN CONTINUOUS WAVE, WHICH IS A TREATMENT TO RESOLVE REFRACTORY GLAUCOMA, THE SURGEON REPORTED SCLERAL PERFORATION IN THE PATIENT'S LEFT EYE. IT WAS REPORTED THAT LASER APPLICATION WAS PERFORMED USING TWO ROWS OF TREATMENT SPOTS. A SUTURE WAS USED TO CLOSE THE PERFORATION. THE SURGEON DISCONTINUED THE USE OF THE DELIVERY DEVICE AND OPENED ANOTHER DELIVERY DEVICE AND WAS ABLE TO FINISH THE LASER PROCEDURE. ALTHOUGH, CONJUNCTIVAL AND SCLERAL BURNS ARE KNOWN AND DOCUMENTED COMPLICATIONS OF TSCPC AND TYPICALLY RESOLVE WITHOUT INTERVENTION WITHIN 24 - 48 HOURS, CONJUNCTIVAL AND/OR SCLERAL PERFORATION ARE NOT CONSIDERED A COMMON OCCURRENCE AND MAY REQUIRE MEDICAL INTERVENTION SUCH AS THE USE OF A SUTURE TO MANAGE THE PERFORATION. THE DELIVERY DEVICE IFU WARNS THE USER OF POTENTIAL CONTRIBUTORS TO SCLERAL BURNS RESULTING IN SCLERAL PERFORATION. THE POSSIBLE CONTRIBUTORS INCLUDE (1) EXCESSIVE POWER AND/OR ENERGY DELIVERED, (2) THE PRESENCE OF BLOOD AND/OR TISSUE BENEATH THE DELIVERY DEVICE FOOTPLATE, (3) THE PRESENCE OF PIGMENT OR P

  Patient problems: Eye Injury

  MAUDE report 25087324 ↗