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

Model Number 66245

Device Problem Use of Device Problem (1670)

Patient Problem Eye Burn (2523)

Event Date 09/09/2022

Event Type  Injury  

Event Description

Iridex became aware of a patient experiencing conjunctival burn during treatment with a cyclo g6 laser system.The delivery device used for the treatment is unknown.The treating surgeon has reported the presence of blood during treatment.The most likely cause for the burn is the activation of laser with the presence of contamination.The activation of laser with the presence of blood on the fiber channel is the possible root cause for this adverse event.However, per the delivery device ifu, 'scleral burns are not typical and may indicate contamination at the device tip.The ifu also instructs the user to discontinue use and replace the device immediately if a scleral burn occurs.The fact that multiple burns were reported suggests that the device tip became contaminated with tissue or blood during use and that the contamination was'nt observed and the treatment was continued.Iridex will request the customer to return the laser system and the delivery device associated with this incident.

• Brand Name: CYCLO G6 SYSTEM
• 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: 15608133
• MDR Text Key: 301763302
• Report Number: 2939653-2022-00032
• Device Sequence Number: 1
• Product Code: HQF
• 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: 10/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 66245
• 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