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

Catalog Number 8065753057

Device Problems No Display/Image (1183); Failure to Power Up (1476)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/31/2020

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 midway during a cataract extraction procedure the system failed, the screen went blank and it could not be turned back on.A system message was not displayed advising of loss of power.The procedure was completed using an alternate system.There was no harm to the patient.

Manufacturer Narrative

The system was examined and the reported event was confirmed and replicated.As such, the host was subsequently replaced to resolve the issue.The system was tested and found to meet product specifications.The manufacturing device history record (dhr) was reviewed.Based on assessment, the product met specifications at the time of release.The host module was received for evaluation.A visual assessment of the returned sample found discoloration around the connector.The host was installed on a calibrated system.The system booted up.However, system message ¿mechanism timeout¿ was displayed and a red light was flashing inside the host.The multi-functional in-out (mfio) printed circuit board assembly (pcba) component was then installed on the calibrated system.The system attempted to power up with no success.The second host module cpu was installed and booted up and no problem was found.The root cause of the reported event can be attributed to the nonconforming component and host.The manufacturer internal reference number is: (b)(4).

• Brand Name: CENTURION VISION SYSTEM (ACTIVE SENTRY)
• Type of Device: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER; 15800 alton parkway; irvine CA 92618
• MDR Report Key: 10587010
• MDR Text Key: 209134513
• Report Number: 2028159-2020-00773
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• PMA/PMN Number: K161794
• 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: 02/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8065753057
• Device Lot Number: 138VTM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2020
• Date Manufacturer Received: 01/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1