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

Model Number	66245
Health Effect - Clinical Code	Heart Failure (2206)
Date of Event	06/17/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
Iridex became aware of the complaint involving patient experiencing cardiac arrest following a transcleral laser therapy treatment using cyclo g6 with a micropulse p3 probe.The patient was given general anaesthesia versus the local peribulber or retrobulbar anaesthesia as suggested in the product indications for use.The most likely cause for this event is suspected to be the combination of general anaesthetic and underlying patient health conditions.The laser therapy is not believed to have caused or contributed to this event.However a definitive conclusion on cause could not be determined.The patient was treated and recovered.Failure analysis was performed on the returned device.No malfunctions or errors were observed.The results indicate the system is functioning within specifications.

• Brand Name: CUST-CYLCO-G6
• Common Device Name: LASER INSTRUMENT, SURGICAL, POWERED, PRODUCT CODE: HQF
• Manufacturer (Section D): IRIDEX CORPORATION; 1212 terra bella ave.; mountain view CA 94043 1824
• MDR Report Key: 10793425
• Report Number: 2939653-2020-00008
• Device Sequence Number: 1137932
• Product Code: HQF
• UDI-Device Identifier: 00813125016555
• UDI-Public: 0100813125016555
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/13/2020

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
• Device Catalogue Number: (01) 00813125016555
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/05/2020
• 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