MAUDE Adverse Event Report:; LASER INSTRUMENT, SURGICAL, POWERED, PRODUCT CODE: HQF

Model Number	66245
Health Effect - Clinical Codes	Blurred Vision (2137); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	09/21/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Iridex became aware of a complaint reporting a case of mydriasis followed by blurry vision post treatment using a cyclo g6 console with a micropulse p3 probe.Mydriasis is a condition where the pupil of the eye is fixed and dilated.The doctor was a new iridex device user.The procedure was intended by an iridex representative who confirmed that treatment settings were within specification and the doctor used a good technique.In this case the patient was highly myopic.In cases where the patient is highly myopic it can be difficult to distinguish the region of the limbus.This may result in the probe being positioned incorrectly (e.G.Positioned too anterior).If treatment was performed in the incorrect location, this could be a contributing factor to the observed result.This complaint did not involve any report of malfunction of the laser console and probe.A definitive root cause cannot be determined.

• Common Device Name: LASER INSTRUMENT, SURGICAL, POWERED, PRODUCT CODE: HQF
• MDR Report Key: 12677628
• Report Number: 2939653-2021-00018
• Device Sequence Number: 19780273
• Product Code: HQF
• UDI-Device Identifier: 00813125016555
• UDI-Public: 0100813125016555
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/15/2021

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
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/21/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other