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

Model Number LXT

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/02/2018

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 surgeon reported two cassettes were found to have leakage at their interface before surgery.There was no patient involvement.This is one of three reports for this surgeon.

Manufacturer Narrative

As the customer did not retain the finished goods lot number, device history record (dhr) and lot history could not be reviewed.A sample for this complaint report has not been received; 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.Manufacturing has reviewed this complaint and will continue to monitor data for evidence of adverse trending and take further action, as appropriate.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

Two unused posterior packs were visually inspected and no obvious defects were observed.The balls in the drip chambers¿ check valves moved freely per specification.The nifs area of the samples appeared to be 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.The samples were tested using a calibrated console representing a current software version.The samples could prime, and pass intraocular (iop) calibration successfully.No anomalies were observed during priming.No system message code was generated during testing.The infusion, irrigation, and aspiration performance was tested at specific data points and met specification.No leakage was detected from the manifolds, connectors, or drain path between the consumable and console.After functional testing no leakage was detected from the pump elastomer or on the pump area of the fluidics module.The presence of fluid leaking from the cassette was not confirmed.After both leakage and console laboratory testing, inspection of the sample indicated no signs of leakage from the infusion or pump elastomer or cassette.Furthermore, there were no signs of fluid leakage onto the fluidics console due to leakage from the cassette.The cassette passed functional and performance testing.After investigation of this complaint, it has been determined that this sample functioned per 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, LLC - IRVINE TECHNOLOGY CENTER; 15800 alton parkway; irvine CA 92618
• MDR Report Key: 8165395
• MDR Text Key: 130622951
• Report Number: 2028159-2018-02612
• 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: foreign,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 07/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2018
• 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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2019
• Date Manufacturer Received: 06/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CONSTELLATION SURGICAL PROCEDURE PAK