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

Model Number TABLETOP

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/08/2019

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.(b)(4).

Event Description

An equipment manager reported that one of the tubing kept disconnecting from the console during a vitrectomy procedure.The procedure was completed with someone holding the tubing in place.There was no patient harm.

Manufacturer Narrative

The lot complaint history was reviewed, this is the third complaint for the finish goods lot; however, the first for this issue for this lot.The device history record shows the product was released per specifications.The used sample was visually inspected and the tubing manifolds were cut off with the connectors fully engaged to the cassette in returned condition.There was about three inches of tubing still connected to the engaged connector.Replacing the cutoff tubing manifolds, the cassette was tested on a calibrated console and could prime and pass intraocular pressure (iop) calibration successfully.The infusion pressure was measured at multiple set points throughout the console range and met specifications.Fluid flowed from the balanced salt solution bottle to the drain bag without any interfering.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.No anomalies were observed during testing.The root cause of the customer's complaint could not be established; the returned sample functioned per specifications.It was noted the tubing manifolds were cut-off, in returned condition.After investigation of this complaint, it has been determined that this sample functioned per 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.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: 8671130
• MDR Text Key: 147300382
• Report Number: 2028159-2019-01011
• 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,other
• Type of Report: Initial,Followup
• Report Date: 08/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/25/2020
• Device Model Number: TABLETOP
• Device Catalogue Number: 8065751150
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/21/2019
• Initial Date Manufacturer Received: 05/14/2019
• Initial Date FDA Received: 06/05/2019
• Supplement Dates Manufacturer Received: 08/12/2019
• Supplement Dates FDA Received: 08/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CONSTELLATION SURGICAL PROCEDURE PAK