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

Catalog Number 8065751763

Device Problem Device Inoperable (1663)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/19/2018

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.(b)(4).

Event Description

A nurse reported that the vacuum failed during a procedure.The physician noted the pressure in the equipment did not have pressure.The product was replaced and procedure completed with no patient harm.

Manufacturer Narrative

This is the first complaint reported for this finished goods lot.Review of the device history record indicates the order was built to specification.The customer has not returned a sample for this complaint report; functional testing could not be conducted.However a sample was expected and this file will be reopened if a sample returns.The root cause of the customer's complaint could not be determined as a sample was not returned.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.Quality assurance will continue to monitor customer complaints via the complaint review meetings, and will take action for any future occurrences as is deemed necessary.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

The wet returned sample was visually inspected and no obvious defects were observed.Both irrigation and aspiration luers were intact.The fluid management system was tested and failed to prime generating a system message (sm) 162 which occurs as a result of a vacuum check failure during set-up.A leak was observed at the aspiration tubing to cassette insertion.The aspiration tubing was pulled out from the cassette.Microscopic examination found the presence of adhesive residue around the distal end of the tubing indicating the tubing was wetted by adhesive and bonded to the aspiration port at one time.The root cause of the customer's event could not be conclusively determined with the information available.The results are not consistent with the reported timing of the event (i.E.During surgery).Functional testing indicated the cassette would not have passed calibration or priming and low vacuum would have been detected prior to the start of the surgery.A potential root cause could be the aspiration tubing may have been tugged at post receipt of the sample but this cannot be confirmed.No action will be taken for this occurrence, as the root cause could not be determined conclusively.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: CENTURION 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: 7553769
• MDR Text Key: 109742658
• Report Number: 2028159-2018-01102
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• PMA/PMN Number: K121555
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/24/2019

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: Other
• Device Catalogue Number: 8065751763
• Other Device ID Number: 380657517633
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2019
• Initial Date Manufacturer Received: 05/14/2018
• Initial Date FDA Received: 05/30/2018
• Supplement Dates Manufacturer Received: 06/01/2018; 04/19/2019
• Supplement Dates FDA Received: 06/11/2018; 04/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CENTURION SURGICAL PROCEDURE PAK
• Patient Outcome(s): Other