MAUDE Adverse Event Report: IRIDEX CORPORATION IQ532; LASER SYSTEM

Catalog Number	IQ 577
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Visual Impairment (2138)
Date of Event	04/25/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The system software will not allow the unit to switch from micropulse mode to continuous wave mode unless the unit is in standby mode and the settings are changed manually.Iridex has not been able to reproduce a failure where a laser console switches modes while the console is in treatment mode.In this case, the user reported the power settings used as follows: power 700 mw, pulse duration 200 ms (at 5% duty cycle) and the spot size was 125 micron.The user did not indicate what interval was used and it is possible that the interval was not selected when the settings were entered.If the duty cycle of 5% is selected, the default interval is 1.9ms.If the duty cycle was not entered, the interval would default to the last interval set in the system.In the latter case, it is possible that the exposure may have exceeded what was intended.However, this is not confirmed and failure analysis on the unit has not been completed.
Event or Problem Description
Iridex received a report which alleged that during a procedure a console (iq532) was set in micropulse mode however fired in continuous wave mode.This resulted in a macular burn.In conjunction with the iq532 console a slitlamp adapter (sla), serial number (b)(4), was used as a delivery device.

• Brand Name: IQ532
• Common Device Name: LASER SYSTEM
• Manufacturer (Section D): IRIDEX CORPORATION; 1212 terra bella avenue; mountain view CA 94043 1824
• MDR Report Key: 8633094
• Report Number: 2939653-2019-00006
• Device Sequence Number: 1924654
• Product Code: GEX
• UDI-Device Identifier: 00813125016616
• UDI-Public: (01)00813125016616
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K071687
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 05/22/2019

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 Catalogue Number: IQ 577
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/25/2019
• Initial Report FDA Received Date: 05/22/2019
• 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