MAUDE Adverse Event Report: Iridex Corporation CYCLO G6 LASER CONSOLE

Model Number	66245-1
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Visual Disturbances (2140)
Date of Event	05/19/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
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 tip approximately 3 mm posterior to the limbus.In eyes with significant globe-size abnormalities, such as severe nanophthalmos, internal ocular anatomy may differ substantially from that of a normally proportioned adult eye.As a result, standard probe placement and treatment parameters may not correspond to the intended internal target with the same degree of predictability.The patient's reduced globe dimensions due to pre-existing nanophthalmos may have altered the distribution of laser energy when compared to a normally sized eye.Whether this resulted in increased tissue exposure or contributed directly to the reported outcome cannot be determined based on the available information.No evidence was identified to suggest a device malfunction or that the device operated outside its specified performance parameters.However, severe nanophthalmos represents an unusual anatomical condition that may increase susceptibility to treatment-related complications.The reported treatment power of 2000 mw is consistent with the settings described in the cyclo g6 operator manual and mp3 probe ifu.The micropulse treatment instructions further describe a 31.3% duty cycle and multiple sweeping passes, while emphasizing individualized treatment planning and conservative escalation of treatment parameters when the anticipated clinical response is uncertain.The cyclo g6 laser console operator manual identifies as a contraindication any situation in which the target tissue cannot be adequately visualized or stabilized.It was not reported whether the physician reduced intraocular pressure prior to treatment to stabilize the eye or otherwise confirmed adequate stabilization.Consequently, iridex is unable to determine whether treatment was performed fully within the indicated conditions for use.Additionally, the operator manual specifies that the clinical needs of each patient should be individually evaluated based on the indication for treatment, treatment location, and the patient's medical history, including factors that may affect wound healing.The mp3 probe and cyclo g6 laser console were not returned to iridex for evaluation despite multiple requests to both the treating physician and the iridex representative.Therefore, no device testing or physical inspection could be performed as part of the investigation.Based on the information available, the reported event is consistent with the development of post-treatment hypotony followed by phthisis bulbi and significant loss of globe volume in a patient with advanced glaucoma and severe pre-existing nanophthalmos.The patient's unusual ocular anatomy may have increased the procedural risk and susceptibility to adverse outcomes.While a definitive causal relationship cannot be established, the event is considered most likely related to the treatment in the context of the patient's severe pre-existing anatomical abnormalities, underlying disease state, and other patient-related factors.
Additional Manufacturer Narrative
Iridex does not carry out servicing for probes and if the probes are used during treatment, it is recommended to dispose them as they become biohazard.No other failure mode identified.

• Brand Name: CYCLO G6 LASER CONSOLE
• Common Device Name: CYCLO G6 LASER CONSOLE
• Manufacturer (Section D): Iridex Corporation; 1212 terra bella avenue; mountain view CA 94043 -182
• Manufacturer (Section G): Iridex Corporation; 1212 terra avenue; mountain view CA 94043 -182
• Manufacturer Contact: bill hyatt ; 1212 terra bella avenue; mountain view, CA 94043--182 ; +1(650)605-8727
• MDR Report Key: 50059856
• Report Number: 2939653-2026-00013
• Device Sequence Number: 9349289
• Product Code: GEX
• UDI-Device Identifier: 00813125015374
• UDI-Public: 00813125015374
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K143154
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/28/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 66245-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/29/2026
• Initial Report FDA Received Date: 07/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 50 YR
• Patient Sex: Female