MAUDE Adverse Event Report: IRIDEX CORPORATION CYCLO G6; LASER INSTRUMENT, SURGICAL, POWERED, PRODUCT CODE: HQF

Device Problem Use of Device Problem (1670)

Patient Problem Eye Burn (2523)

Event Date 03/28/2022

Event Type  Injury  

Event Description

Iridex became aware of a complaint reporting that the tip of the probe began emitting smoke during the procedure.The procedure was performed using a micropulse p3 probe and cyclo g6 laser system.It was noted before the procedure that patient had lightly pigmented conjunctiva.Pigmented conjunctiva presents a known procedural risk because the pigmented tissue can absorb the laser energy and increase the chance of a tissue burn occurring.In this case, the doctor reported that smoke was observed coming from the tip of the device at the beginning of treatment.The doctor aborted the procedure after this observation.A conjunctival burn was observed, and the doctor performed treatment for the burn.The most likely cause of this event is the activation of the laser over the areas pigmented conjunctiva.After activation, some tissue was transferred to the device tip and the laser was activated again resulting in the "smoking tip".The ifu provides instructions to the user to examine the tip of the device to make sure no blood or other contaminants are present.Per the ifu contamination of the fiber optic tip by blood or tissue char may result in ocular surface burns.Heavy perilimbal conjunctival pigmentation may result in local absorption and burns; therefore, avoid areas of heavy perilimbal pigmentation.The manufacturing device history records were reviewed, and no anomalies or issues were identified.The results of post market data review suggest that this failure mode is not occurring with greater severity or frequency based on the number of events reported evaluated against the number of cases performed.

• Brand Name: CYCLO G6
• Type of Device: LASER INSTRUMENT, SURGICAL, POWERED, PRODUCT CODE: HQF
• 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: madhumita srikanth ; 1212 terra bella ave.; mountain view, CA 94043-1824 ; 6502189149
• MDR Report Key: 14277485
• MDR Text Key: 290705861
• Report Number: 2939653-2022-00011
• Device Sequence Number: 1
• Product Code: HQF
• UDI-Device Identifier: 00813125015220
• UDI-Public: 0813125015220
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other