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

Catalog Number 8065752200

Device Problem Obstruction of Flow (2423)

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

Event Date 02/14/2024

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 they got signal for occlusion during phacoemulsification chop step.The surgery was completed by changing the cassette.There was no patient harm.

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.A signal for occlusion during surgery was reported.A wet active fluidics management system in a tray was visually inspected and was tested using a console.The sample could be recognized by the console.The sample primed and tuned with the handpiece and aspiration bypass system tip and infusion sleeve from lab stock, successfully and the service data could be retrieved.No system message code displayed on console screen.The sample functioned within specification.Cassette maximum vacuum and aspiration flow rate, and irrigation flow rate were measured and met specifications.No problem was found with the returned cassette fluidics.The root cause of the customer's complaint could not be established; the returned sample functioned per specification.This complaint has been reviewed and it is determined that no further actions will be pursed at this time as the sample met specifications.Based on our current tracking, there are no adverse trends for this reported complaint.Quality assurance has reviewed this complaint and 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 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: 18874628
• MDR Text Key: 337334794
• Report Number: 1644019-2024-00442
• Device Sequence Number: 1
• Product Code: LRO
• UDI-Device Identifier: 00380657522002
• UDI-Public: 00380657522002
• Combination Product (y/n): N
• Reporter Country Code: SW
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/11/2024

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: 8065752200
• Device Lot Number: 1692W6
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/19/2024
• Initial Date FDA Received: 03/11/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/21/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1