MAUDE Adverse Event Report: IRIDEX; OCULIGHT

Model Number SLX

Device Problems Energy Output To Patient Tissue Incorrect (1209); Device Displays Incorrect Message (2591)

Patient Problem Burn(s) (1757)

Event Date 08/12/2016

Event Type  Injury  

Event Description

I was doing laser photocoagulation (using the iridex 810 nm laser, ecn 080356), for stage 3 retinopathy of prematurity in the right eye and was nearing completion (having fired over 1000 shots) with a maximum power of 130 mw and maximum duration of 150 msec when there was an apparent power surge and a very hot laser burn which appeared to break the inferior retina at 5 o'clock.There was a trace amount of heme.I immediately looked at the laser display panel and it said type 1 service error and the laser had automatically put itself in standby mode.I held pressure and there was no active bleeding and no retinal detachment.I turned the laser back off and then on and did light photocoagulation around this hot spot with the laser during the treatment of rop, of unclear significance at this point.I further emphasized the fact that we would follow the patient closely.(this statement is from the provider for the event on (b)(6) 2016.) to this point, the patient is doing fine and the laser treatment has had the intended effect.I am going to see the baby again this thursday.(this statement is from the provider, today, 08/24/2016.).

• Brand Name: IRIDEX
• Type of Device: OCULIGHT
• MDR Report Key: 5913395
• MDR Text Key: 53600373
• Report Number: MW5064427
• Device Sequence Number: 1
• Product Code: GEX
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 08/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SLX
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 46 YR