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

Catalog Number 8065753057

Device Problems Failure to Deliver Energy (1211); Self-Activation or Keying (1557)

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

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 that an ophthalmic operating console failed multiple times and exhibited no phacoemulsification power.The touch screen displayed ultra-chop at bottom port when port is not was not in use.The procedure details and patient impact were not reported.Additional information has been requested but none received till date.

Manufacturer Narrative

The company representative was able to resolve the reported event by discovering that two handpieces (hps) were plugged into the console when it only should have one plugged in one at a time.This impacted ¿phaco power.¿ additionally, one of the handpieces (plugged in), was another kind of hp which is what prompted ¿ultra-chop¿ from the system.The system was tested and found to meet product specifications.A non-conformance based review of the serial number was performed and did not reveal any potential contributing factors to the reported complaint.A manufacturing device history record (dhr) review was performed prior to product release to ensure that the product was manufactured in compliance with the device master record.Based on the assessment, the product met release criteria.A review for complaints reported against this serial number was performed there were none relevant to this event, found.The root cause of the reported event is attributed to handpiece customer misuse and is unrelated to the functionality of the device itself.Manufacturer 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: 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
• Manufacturer (Section G): ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER; 15800 alton parkway; irvine CA 92618
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 17077133
• MDR Text Key: 316663035
• Report Number: 2028159-2023-00806
• Device Sequence Number: 1
• Product Code: HQC
• UDI-Device Identifier: 00380657530571
• UDI-Public: 00380657530571
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161794
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 09/29/2023

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 Catalogue Number: 8065753057
• Device Lot Number: 143YC3
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 05/10/2023
• Initial Date FDA Received: 06/07/2023
• Supplement Dates Manufacturer Received: 09/05/2023
• Supplement Dates FDA Received: 09/29/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1