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	Visual Impairment (2138)
Type of Reportable Event	Serious Injury
Event or Problem Description
Iridex received a report there were two patients that had suffered from mydriasis; one suffered from chronic mydriasis and the other long-term mydriasis.The patients developed mydriasis after treatment from a micropulse p3 device 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
• MDR Report Key: 9703498
• Report Number: 2939653-2020-00003
• Device Sequence Number: 2422506
• Product Code: GEX
• UDI-Device Identifier: 00813125015374
• UDI-Public: (01)00813125015374
• Combination Product (Y/N): N
• 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,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/12/2020

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: 01/16/2020
• Initial Report FDA Received Date: 02/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other