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

Model Number LXT

Device Problems Fluid/Blood Leak (1250); Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/15/2019

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 customer reported the cassette leaked after it was loaded with the console and it failed testing.The product was replaced with another one and the procedure was completed.There was no harm to the operating room staff.There was no patient involvement.No additional information is expected.

Manufacturer Narrative

A calibrated console representing a current software version was then used to test the sample.The sample could prime, and pass intraocular pressure (iop) calibration successfully.No anomalies were observed during priming.No system message code was generated during testing.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.A full internal pressure leak test was then conducted on the cassette utilizing an external pressure source and no leakage was detected.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).

Manufacturer Narrative

The lot complaint history was reviewed, this is the third complaint for the finished goods lot and the first for this issue for this lot.The device history shows the product was released per specifications.No sample was received.Therefore, no visual inspection or functional testing could be conducted.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 no root cause could be established.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: 8549275
• MDR Text Key: 143272522
• Report Number: 2028159-2019-00757
• 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: 09/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2019
• 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: 07/24/2019
• Date Manufacturer Received: 09/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CONSTELLATION SURGICAL PROCEDURE PAK