MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HOUSTON CENTURION SURGICAL PROCEDURE PAK; GENERAL SURGERY TRAY (KIT)

Catalog Number 8065752182

Event Date 04/14/2021

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 an abnormal sound was generated near the fluid management system (fms) cassette insertion port of the console body, air was mixed into the aspiration tube, and the aspiration pressure decreased during the ultrasound phase of a cataract procedure.The product was replaced with another one and the procedure was resumed.There was no harm to the patient.

Manufacturer Narrative

Based on this information received following submission of the initial report, the issue was related to poor aspiration during ultrasound phase of the cataract procedure, this event does not meet criteria for reporting as a malfunction.The manufacturer internal reference number is: (b)(4).

Event Description

The issue was related to poor aspiration during ultrasound phase of the cataract procedure.

• Brand Name: CENTURION SURGICAL PROCEDURE PAK
• Type of Device: GENERAL SURGERY TRAY (KIT)
• Manufacturer (Section D): ALCON RESEARCH, LLC - HOUSTON; 9965 buffalo speedway; houston TX 77054
• MDR Report Key: 11741123
• MDR Text Key: 248861476
• Report Number: 1644019-2021-00291
• Device Sequence Number: 1
• Product Code: LRO
• UDI-Device Identifier: 00380657521821
• UDI-Public: 00380657521821
• Combination Product (y/n): N
• PMA/PMN Number: K880961
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 05/20/2021

1 Device 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: 10/31/2022
• Device Catalogue Number: 8065752182
• Device Lot Number: 2431411H
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/26/2021
• Initial Date FDA Received: 04/28/2021
• Supplement Dates Manufacturer Received: 04/28/2021
• Supplement Dates FDA Received: 05/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No