MAUDE Adverse Event Report: ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER CONSTELLATION VISION SYSTEM; UNIT, PHACOFRAGMENTATION

Model Number LXT

Device Problem Use of Incorrect Control/Treatment Settings (1126)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/17/2017

Event Type  malfunction  

Manufacturer Narrative

A product sample has been received by the manufacturer and it is awaiting evaluation.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.(b)(4).

Event Description

A nurse reported the intraocular pressure was not being maintained due to an unspecified infusion issue during a vitrectomy procedure.The product was replaced, the intraocular pressure was maintained and the procedure was completed.There was no harm to the patient.Additional information was requested; however, none has been received to date.

Manufacturer Narrative

The lot complaint history was reviewed, this is the fifth complaint for the finish goods lot; however, the second for this issue.The device history records shows the product was released per specifications.The used returned sample was visually inspected and surgical residue and balance salted solution (bss) crystals were in the fluid path of the manifolds.The filters in the cassette were saturated with bss.It was noted the infusion cannula was not returned.Full functional and performance testing of the sample was then performed on a console.The ball in the check valve of the drip chamber moved freely per specification.The sample could prime and pass intraocular (iop) calibration successfully.No anomalies were observed during priming.The infusion pressure was measured at multiple set points throughout the console range and met specifications.The value of 7500cpm cut rate, 650mmhg wetant, 650mmhg extrusion, and, 650mmhg vacuum, 650mmhg continuous reflux, and 120mmhg proportional reflux displayed on the progress bar.Toggling the infusion and the fluid/air exchange (f/ax) modes, fluid and air flowed from the cassette to the infusion line continuously without any bubble in various settings in all sub modes.The iop was stable in 15 - 16 cc/min at 30 mmhg setting during f/ax testing.No message code appeared on the screen.Fluid flowed from bss to the drain bag without any interfering.Cleaning process was able to be performed after functional test had completed.The root cause of the customer's complaint could not be established; the returned sample met specifications.After a thorough investigation of this complaint, it has been determined that this sample met specifications; therefore, no corrective action is required at this time.The manufacturer internal reference number is: (b)(4).

• Brand Name: CONSTELLATION VISION SYSTEM
• Type of Device: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER; 15800 alton parkway; irvine CA 92618
• Manufacturer (Section G): ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER; 15800 alton parkway; irvine CA 92618
• Manufacturer Contact: nadia bailey ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8176152230
• MDR Report Key: 7018000
• MDR Text Key: 92511016
• Report Number: 2028159-2017-04239
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K101285
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 01/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LXT
• Device Catalogue Number: 8065751550
• Other Device ID Number: 3.00.61
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/19/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other