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

Model Number	LQP3106-U
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Vitreous Hemorrhage (2143)
Date of Event	10/17/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
There was no device problem which could have led to the event.The device was verified after the event , and it was within specifications although there were certain adjustments done to improve the performance.The user had performed laser floater treatment on the patient.The third pulse caused immediate vitreous hemorrhage from fovea although the laser was focussed anterior to fovea.The user immediately stopped treatment and referred patient to retina specialist.The visual acuity post event was 20/100.The device labeling and risk assessment was reviewed and the risk control measures were found to be adequate.
Event or Problem Description
There was an incident reported on the ellex ultra q reflex laser where the patient developed full thickness macular hole in left eye, immediately after the third laser pulse.This report is made by ellex without prejudice and does not imply any admission of liability for the incident or its consequences.

• Brand Name: ULTRAQ REFLEX
• Common Device Name: OPHTHALMIC LASER
• Manufacturer (Section D): ELLEX MEDICAL PTY LTD; 3-4 second avenue; mawson lakes, 5095 ; AS 5095
• Manufacturer (Section G): ELLEX MEDICAL PTY LTD; 3-4 second avenue; mawson lakes, 5095 ; AS 5095
• MDR Report Key: 18279406
• Report Number: 3002806902-2023-00003
• Device Sequence Number: 6207033
• Product Code: HQF
• UDI-Device Identifier: 09342395000427
• UDI-Public: (01)09342395000427(11)180508
• Combination Product (Y/N): N
• PMA/510(K) Number: K212630
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Remedial Action: Inspection,Patient Monitoring,Notification
• Type of Report: Initial
• Report Date (Section B): 12/06/2023

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: LQP3106-U
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/16/2023
• Initial Report FDA Received Date: 12/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/09/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown