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

Catalog Number 8065753008

Device Problems Suction Problem (2170); Noise, Audible (3273)

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

Event Date 12/19/2023

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 physician reported that the during the epi-nucleus step there was no pull of harder cores and fragments, noises during ultrasound-in-use and console was stopped with system message.The procedure details and patient impact was not reported.

Manufacturer Narrative

The company representative was able to confirm the issue (via event log review) but was unable to replicate it.The fluidics module and fluidics controller were both replaced to address the issue.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 non-conformance based review of the serial number was performed and a potential contributing factor to the reported complaint was identified.A review for complaints reported against this serial number was performed.A potentially relevant complaint was found and reviewed as part of this investigation.The root cause of the reported event is attributed to the nonconforming fluidics module and fluidics controller.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).

Event Description

Additional information received indicating that the patient underwent cataract surgery on (b)(6) 2023.

Manufacturer Narrative

The manufacturer internal reference number is: (b)(4).

• Brand Name: CENTURION SILVER SYSTEM
• 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: 18424143
• MDR Text Key: 331923043
• Report Number: 2028159-2024-00007
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K121555
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8065753008
• Device Lot Number: 15YJLW
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/04/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/20/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1