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

Catalog Number 8065752201

Device Problem Blocked Connection (2888)

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

Event Date 10/07/2021

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.A product sample has been received by the manufacturer and it is awaiting evaluation.The manufacturer internal reference number is: (b)(4).

Event Description

A physician reported the aspiration tube occluded with two different cassette pak during a cataract procedure.The procedure was completed with the third replacement.There was no harm to the patient.This is two of two reports for this event.

Manufacturer Narrative

A review of the device history record traceable to the reported lot number, indicates that the product was processed and released according to the product¿s acceptance criteria.The wet fluidics management system (fms), in the tray was visually inspected and functionally tested.Both irrigation and aspiration luers were intact.Flare shape was observed, in the blue socket fitting at the aspiration tubing insertion end.The sample primed and tuned with a handpiece successfully.The sample could be recognized and the service data could be retrieved from the console.The sample passed functionality testing.The root cause of the customer's complaint could not be established, since the returned sample met specifications.No contributing factors could be identified, that could cause the reported complaint.After the investigation of this complaint.It has been determined, that this sample met specifications.Therefore, no action will be taken at this time.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).

• 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
• Manufacturer (Section G): ALCON RESEARCH, LLC - HOUSTON; 9965 buffalo speedway; houston TX 77054
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 12746802
• MDR Text Key: 279944291
• Report Number: 1644019-2021-00684
• Device Sequence Number: 1
• Product Code: LRO
• UDI-Device Identifier: 00380657522019
• UDI-Public: 00380657522019
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K880961
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 01/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2023
• Device Catalogue Number: 8065752201
• Device Lot Number: 2463336H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/05/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1