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

Model Number TABLETOP

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/18/2018

Event Type  malfunction  

Manufacturer Narrative

Investigation, including root cause analysis, is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.The manufacturer internal reference number is: (b)(4).

Event Description

A nurse reported that infusion stopped working during a cataract/vitrectomy procedure.The console presented an advisory indicating "fluid empty change container".The container was half full.Balanced salt solution was noticed running down the front of the console from the cassette.The fluidics management system and tubing were changed and the procedure was completed.There was no patient impact.A possible cause of the occurrence was reported to be user error due to an inexperienced user not securing the tubing tightly during connection.Additional information was requested and received.

Manufacturer Narrative

The lot complaint history was reviewed; this is the first complaint for the finish goods lot and first for this issue for this lot.The device history record shows the product was released per specifications.A sample for this complaint report has not been received to date; visual inspection or functional testing could not be conducted in order to ascertain the failure mode for the consumable device.The root cause of the customer's complaint could not be established as a sample has not been received.Without analysis of the sample, it is not possible to isolate the root cause.As the root cause is unknown, the relationship, if any, of the device to the reported incident cannot be determined.After an investigation of this complaint, it has been determined that no action will be taken at this time as a sample was not returned and a root cause evaluation could not be performed.Quality assurance has reviewed this complaint and will continue to monitor data for evidence of adverse trending and take further action, as appropriate.Consumables manufacturing management has been made aware of this complaint through the consumer affairs review meeting.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

The lot complaint history was reviewed; this is the first complaint for the finish goods lot and first for this issue for this lot.The device history record shows the product was released per specifications.The returned sample was visually inspected and no obvious defects were found.The non-invasive flow sensor (nifs) on the cassette housing was in good condition.A full internal pressure leak test was then conducted on the cassette utilizing an external pressure source and no leakage was detected.A calibrated console representing the current software version was used to test the sample.The led rings on the console turned green as the probe connectors were engaged to the console indicating the proper communication between the probe and the console.The ball in the check valve of the drip chamber moved freely per specification.The sample could prime and pass intraocular pressure (iop) calibration successfully.No anomalies were observed during priming.The infusion pressure, irrigation, and aspiration rate were all measured at multiple set points throughout the console range and met specifications.Iop was stable during functional and performance testing.The iop stayed active during testing process.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.No message code appeared on the screen during functional testing.Fluid flowed from balanced salt solution (bss) to the drain bag without any interfering.No leakage was detected from the manifolds, connectors, or drain path between the consumable and console.No leakage was detected from the pump elastomer or on the pump area of the fluidics module.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.There was no infusion flow interruption or leakage identified during evaluation of the device.After investigation of this complaint, it has been determined that this sample met specifications; therefore, no corrective action is required at this time.Quality assurance has reviewed this complaint and will continue to monitor data for evidence of adverse trending and take further action, as appropriate.Consumables manufacturing management has been made aware of this complaint through the consumer affairs review meeting.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
• MDR Report Key: 8230927
• MDR Text Key: 132574419
• Report Number: 2028159-2019-00063
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• PMA/PMN Number: K101285
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 05/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TABLETOP
• Device Catalogue Number: 8065751150
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2019
• Date Manufacturer Received: 04/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CONSTELLATION SURGICAL PROCEDURE PAK
• Patient Age: 3 MO