MAUDE Adverse Event Report: IRIDEX CORPORATION CYCLO G6; LASER SYSTEM

Model Number	66245-1
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Radiation Burn (1755)
Date of Event	12/12/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Responses to requests from iridex for additional information have not been received.This report will be updated if additional information becomes available.
Event or Problem Description
Iridex received a report of a patient injury involving a scleral burn.The burn occurred during a treatment with the g-probe illuminate device in conjunction with a cyclo g6 laser console.

• Brand Name: CYCLO G6
• Common Device Name: LASER SYSTEM
• Manufacturer (Section D): IRIDEX CORPORATION; 1212 terra bella avenue; mountain view CA 94043 1824
• MDR Report Key: 9578474
• Report Number: 2939653-2019-00014
• Device Sequence Number: 14178745
• Product Code: GEX
• UDI-Device Identifier: 00813125016555
• UDI-Public: 0100813125016555
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K143154
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/10/2020

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
• Device Catalogue Number: 66245-1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/12/2019
• Initial Report FDA Received Date: 01/10/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other