MAUDE Adverse Event Report: ELLEX MEDICAL PTY LTD ULTRA Q REFLEX; OPHTHALMIC LASER

Model Number	LQP3106-U
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Eye Injury (1845)
Date of Event	12/15/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The system has been in use since jul'2017 , and is being used till date , there were no other adverse events reported for the system.The cause can be attributed to the user continuing the laser treatment despite the coaxial illumination not working resulting in inaccurate targeting on the natural lens ,leading to traumatic cataract.The device labeling and risk control measures were verified and were deemed adequate.
Event or Problem Description
Ellex services europe received a complaint from the user facility that the surgeon performed a floater treatment on a phakic patient without coaxial illumination, which led him to shoot the crystalline lens causing an immediate traumatic cataract.The event occurred in (b)(6) 2019 however was communicated to the ellex service tech during the subsequent service call on 4thmay'2020.The patient had been advised for cataract surgery.This report is made by ellex without prejudice and does not imply any admission of liability for the incident or its consequences.

• Brand Name: ULTRA Q REFLEX
• Common Device Name: OPHTHALMIC LASER
• Manufacturer (Section D): ELLEX MEDICAL PTY LTD; 3-4 second avenue; mawson lakes, 5095 ; AS 5095
• MDR Report Key: 10099860
• Report Number: 3002806902-2020-00004
• Device Sequence Number: 19496629
• Product Code: HQF
• UDI-Device Identifier: 09342395000427
• UDI-Public: (01)09342395000427(11)170714
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K021550
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Remedial Action: Notification,Inspection,Patient Monitoring
• Type of Report: Initial
• Report Date (Section B): 05/29/2020
• Report Date (Section F): 05/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: LQP3106-U
• Was Device Available for Evaluation?: No
• Device Age: 34 MO
• Date Report to Manufacturer: 05/19/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/19/2020
• Initial Report FDA Received Date: 05/29/2020
• 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: Required Intervention