MAUDE Adverse Event Report: IRIDEX CORPORATION CUST-IQ577; LASER INSTRUMENT, SURGICAL, POWERED, PRODUCT CODE: HQF

Model Number	IQ577
Health Effect - Clinical Code	Loss of Vision (2139)
Date of Event	02/13/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
Iridex became aware of the complaint involving patient experiencing macular vision loss after treatment.The surgeon reported observing what appeared to be a plaque on the eye and reported that he did not observe any tissue burns.Failure analysis was performed on the returned console and delivery device.The results indicate the system is functioning within specifications.No malfunctions or errors were observed that could contribute to this observation.

• Brand Name: CUST-IQ577
• 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: 10793256
• Report Number: 2939653-2020-00004
• Device Sequence Number: 2953718
• Product Code: GEX
• UDI-Device Identifier: 00813125016265
• UDI-Public: 00813125016265
• 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): 08/12/2020

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: IQ577
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/17/2020
• 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