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	Retinal Injury (2048)
Date of Event	03/08/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As soon as ellex medical became aware of the incident, ellex has verified the performance of the unit through a product acceptance fault (paf) record.The unit operates to specifications and the minor misalignment could not have caused the adverse event as was also confirmed by the physician.The physician mentioned the patient status would resolve with time.Future visual acuity checks will take place again in the coming weeks.He feels confident that the patient's va will continue to improve.The complaint also mentioned about pitting of the iol by another doctor however the visual acuity was unaffected.The general device aspects with respect to usability, instructions for use and the risk controls were evaluated.Adequacy of device design : indications of parameters relevant to safety: anterior and posterior offset located on the laser head control knob are letter and colour coded.Accuracy of controls : offset range is well defined with the required tolerance.Adequacy of labelling: operator manual includes sufficient instructions , warnings, precautions for the safe use of the device and the labelling is considered adequate.Risk management :the risk assessment include the risk control measures for risk (b)(4).Customer complaints : the device has been in use for approximately less than 2 years from the date of manufacture, no other untoward incidents related to device use were reported apart from this event.Any subsequent findings on patient status will be updated through a follow-up report.E2018008.
Event or Problem Description
Doctor inadvertently hit a patient's retina in the left eye with the yag laser and it created a small contusion noted by a white mark and this caused a moderate bleed into the vitreous which reduced the patient's visual acuity.

• Brand Name: ULTRA Q REFLEX
• Common Device Name: OPHTHALMIC LASER
• Manufacturer (Section D): ELLEX MEDICAL PTY LTD; 3-4 second avenue; mawson lakes, south australia 5095 ; AS 5095
• MDR Report Key: 8480547
• Report Number: 3013515803-2019-00001
• Device Sequence Number: 19087481
• Product Code: HQF
• UDI-Device Identifier: 09342395000427
• UDI-Public: (01)09342395000427(11)170828
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K021550
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,user faci
• Initial Reporter Occupation: Other
• Remedial Action: Notification,Inspection,Patient Monitoring,Modification/Adjustment
• Type of Report: Initial
• Report Date (Section B): 03/26/2019

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 Model Number: LQP3106-U
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 03/13/2019
• Device Age: 2 YR
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/14/2019
• Initial Report FDA Received Date: 04/03/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other