Cyclo G6 Laser Console 66245Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00813125015374), received between Feb 12, 2020 and Jul 28, 2026 — classified as 6 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (3 reports).

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryJul 28, 2026Adverse Event Without Identified Device or Use Problem

  It was reported to Iridex that a patient with bilateral secondary glaucoma & bilateral nanophthalmos, underwent MicroPulse transscleral laser treatment using an IRIDEX Cyclo G6 laser console and a MicroPulse P3 (MP3) delivery device. Six months following treatment, the patient was unable to open the treated left eye. Clinical evaluation revealed phthisis bulbi, characterized by significant globe atrophy. Phthisis bulbi is a shrunken, non-functional, and disorganized end-stage ocular condition that may result from severe trauma, chronic inflammation, or infection. It is typically associated with permanent vision loss, hypotony (low intraocular pressure), and structural collapse of the globe.The patient had a pre-existing diagnosis of severe nanophthalmos, a developmental ocular condition characterized by an abnormally small eye due to compromised ocular growth. Nanophthalmos is generally congenital or present from early childhood and is recognized within the spectrum of developmental eye disorders.According to the MP3 Probe Instructions for Use (IFU), the probe tip protrudes 0.4 mm from the handpiece and is specifically designed to facilitate accurate positioning of the fiber-optic

  Patient problems: Visual Disturbances

  MAUDE report 50059856 ↗
• InjuryOct 14, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IRIDEX BECAME AWARE OF A PATIENT EXPERIENCING CONJUNCTIVAL BLANCHING DURING TREATMENT WITH A CYCLO G6 LASER SYSTEM. THE DELIVERY DEVICE USED FOR THE TREATMENT IS UNKNOWN. 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. IRIDEX WILL CONTINUE TO FOLLOW-UP WITH THE DOCTOR FOR INFORMATION REGARDING PATIENT RECOVERY.

  Patient problems: Eye Burn

  MAUDE report 15608036 ↗
• InjuryJul 15, 2022Insufficient Device Problem Information

  IRIDEX BECAME AWARE OF A PATIENT EXPERIENCING CHARRING ON THE EYE DURING TREATMENT WITH A CYCLO G6 LASER SYSTEM. THE DELIVERY DEVICE THAT WAS USED IN COMBINATION WITH THE CYCLO G6 IS UNKNOWN, AND NO RESPONSE WAS PROVIDED BY THE CUSTOMER TO IRIDEX FOLLOW-UP EMAILS. 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. IRIDEX WILL CONTINUE TO FOLLOW-UP WITH THE DOCTOR FOR INFORMATION REGARDING PATIENT RECOVERY.

  Patient problems: Eye Injury

  MAUDE report 15028823 ↗
• InjuryMay 27, 2022Adverse Event Without Identified Device or Use Problem

  IRIDEX BECAME AWARE OF A COMPLAINT REPORTING A PATIENT EXPERIENCING CONJUNCTIVAL BURN DURING TREATMENT WITH THE MICROPULSE P3 PROBE. THE TREATMENT WAS PERFORMED WITHIN SPECIFICATIONS. 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. ENGINEERING FAILURE ANALYSIS WAS NOT PERFORMED BECAUSE THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE MICROPULSE P3 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. IF THE DEVICES ARE RETURNED AND THE RESULTS OF FAILURE ANALYSIS INDICATE NEW INFORMATION, THE ADVERSE EVENT REPORT WILL BE AMENDED. THE RESULTS OF POST MARKET DATA REVIEW INDICATE THAT THIS FAILURE MODE IS NOT OCCURRING WITH GREATER SEVE

  Patient problems: Eye Burn

  MAUDE report 14528471 ↗
• InjuryFeb 12, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IRIDEX RECEIVED A REPORT THERE WERE TWO PATIENTS THAT HAD SUFFERED FROM MYDRIASIS; ONE SUFFERED FROM CHRONIC MYDRIASIS AND THE OTHER LONG-TERM MYDRIASIS. THE PATIENTS DEVELOPED MYDRIASIS AFTER TREATMENT FROM A MICROPULSE P3 DEVICE WITH A CYCLO G6 LASER CONSOLE.

  Patient problems: Visual Impairment

  MAUDE report 9703498 ↗
• InjuryFeb 12, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IRIDEX RECEIVED A REPORT THERE WERE TWO PATIENTS THAT HAD SUFFERED FROM MYDRIASIS; ONE SUFFERED FROM CHRONIC MYDRIASIS AND THE OTHER LONG-TERM MYDRIASIS. THE PATIENTS DEVELOPED MYDRIASIS AFTER TREATMENT FROM A MICROPULSE P3 DEVICE WITH A CYCLO G6 LASER CONSOLE.

  Patient problems: Visual Impairment

  MAUDE report 9703497 ↗