MAUDE Adverse Event Report: ALCON RESEARCH, LTD. - 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 10/22/2018

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

An ophthalmologist reported that the cassette leaked during preparation for a vitrectomy procedure.The product was replaced and the procedure was completed.There was no patient contact or impact.

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 wet cassette was visually inspected and in returned condition, the infusion elastomer was slightly lifted from the pinch plate.No obvious defects were observed on the infusion elastomer and the pinch plate channel during inspection.It was noted the probe manifold tubing set was not returned.A calibrated console was used to test the returned cassette.The cassette was inserted into the console with the slightly lifted infusion elastomer and the cassette passed the initial vacuum/pressure calibration test.No leakage was identified.The cassette was removed from the console to check for elastomer lift.No lifting was found.A full internal pressure leak test was then conducted on the cassette utilizing an external pressure source and no leakage was detected.The cassette was then reinserted onto the console for functional and performance testing.The sample could prime, tune, and pass intraocular pressure 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.After functional testing no leakage was detected from the pump elastomer or on the pump area of the fluidics module.After testing, 400 millimeter (ml) of fluid was introduced through the cassette to the drain bag, no leakage was found.Cleaning process was able to be performed after functional test was completed.An elastomer air burst test was performed on all the elastomers to ensure full engagement.The cassette passed the elastomer air burst test and functioned within specifications.No anomalies were observed.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 and no leakage was detected; 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: 8058482
• MDR Text Key: 126954767
• Report Number: 2028159-2018-02370
• 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
• Report Date: 01/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2018
• 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: 8065751145
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2019
• Date Manufacturer Received: 01/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BALANCED SALT SOLUTION (BSS); CONSTELLATION SURGICAL PROCEDURE PAK; CUSTOM-PAK SURGICAL PROCEDURE PACK