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 03/31/2022

Event Type  Injury  

Event Description

Iridex became aware of a complaint reporting that the tip of the probe began emitting smoke during the procedure and that the patient experienced a conjunctival burn.The procedure was performed using a micropulse p3 probe and cyclo g6 laser system.A conclusive root cause for this event was not determined.Engineering failure analysis could not be performed because the device was not returned for evaluation.Based on the information provided by the treating physician, it is possible that the substitution of an alternative anesthetic lubricating gel may have contributed to this event.The physician noted that she used more gel that usual and suspected this may have played a role.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: 14277527
• MDR Text Key: 290707505
• Report Number: 2939653-2022-00012
• 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