MAUDE Adverse Event Report: IRIDEX CORPORATION G-PROBE

Model Number	15980-1
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Codes	Eye Injury (1845); Eye Burn (2523)
Date of Event	02/26/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
810 nm ophthalmic laser systems are intended to deliver thermal (laser) energy to deliver an insult (burn) to the ciliary body.Conjunctival burns are a known and predicted complication associated with the use of any 810nm ophthalmic laser system (console and delivery device) when used to deliver transscleral treatment.Conjunctival burns are typically superficial andtypically pose no long-term threat to the patient (i.E., no adverse effect on patient disease state, no requirement for additionalfuture care).Typically, these burns resolve within 24-48 hours post op without additional intervention.The result of these burns requires no post-operative management nor change to the post-operative medication regimen within the normal post-operative appointment schedule.The most likely cause of the reported adverse event is suspected to be contamination (e.G., blood, tissue or betadine) on the probe tip when the laser was activated.The g-probe delivery device ifu warns that contamination at the tip may cause ophthalmic burns: "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".
Event or Problem Description
A 55 year male patient with a known history of moderate primary open angle glaucoma experienced two conjunctival burns in the right eye during treatment with the cyclo g6 laser console and the g-probe delivery device.As reported by the complainant, " on strarting the treatment,patient observed to have conjunctival burns.Probe was inspected and observed to be smoking, even at 1600 mw.Probe discontinued.New probe connected.Treatment completed with new probe." a retrobulbar block anesthetic was applied during the procedure, no vasconstrictor, liquid coupling agent or betadine solution was used.There was no subconjunctival hemorrhage or bleeding present in the surgical field during treatment.It is unknown if the user observed any pigmented legions or dark areas in the surgical field.The patient is recovering well and did not require any further managment.

• Brand Name: G-PROBE
• Common Device Name: G-PROBE
• Manufacturer (Section D): IRIDEX CORPORATION; 1212 terra bella ave; mountain view CA 94043 1824
• Manufacturer (Section G): IRIDEX CORPORATION; 1212 terra bella ave; mountain view CA 94043 9149
• Manufacturer Contact: nimrta tandan ; 1212 terra bella ave; moutntain view, CA 94043-9194
• MDR Report Key: 19525238
• Report Number: 2939653-2024-00013
• Device Sequence Number: 18043982
• Product Code: GEX
• UDI-Device Identifier: 00813125015237
• UDI-Public: 00813125015237
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K915236
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 06/04/2024

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: 15980-1
• Device Lot Number: 200202
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/07/2024
• Initial Report FDA Received Date: 06/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 55 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White