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

Catalog Number 8065752182

Device Problems Mechanical Jam (2983); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Burn, Thermal (2530)

Event Date 12/03/2020

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 surgeon reported a thermal burn was brought by the irrigation solution not running well during the fragmentation phase of the ultrasound oscillation and bubbles came out of the tip.In addition, the tube felt stuck between the tray and console.The procedure was completed without product replacement.Additional information indicated the tip replaced however it was determined the issue was related to the cassette tubing getting stuck.This is one of two reports for this facility.

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.No sample has been returned for evaluation; therefore, the condition of the product could not be verified.It's important to remind the customer, the directions for use instruct the user to observe the stream of irrigating fluid from the irrigation and aspiration ports when the fill button is depressed.If the stream of fluid is weak or absent, good fluidics response will be jeopardized.Good clinical practice dictates the testing for adequate irrigation and aspiration fl ow prior to entering the eye.The root cause of the customer's complaint could not be established as a sample has not been received and the condition of the product could not be verified.Without analysis of the sample, it is not possible to isolate the root cause.As the root cause is unknown, the relationship, if any, of the device to the reported incident cannot be determined.The root cause for this complaint is not known, therefore, specific action with regards to this complaint cannot be taken.In-process controls are established to ensure each final assembled cassette is verified that all required tests have been performed and all acceptance criteria are met prior to release.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

This event does not meet criteria as a reportable malfunction based on information received following submission of the initial report.The manufacturer internal reference number is: (b)(4).

Event Description

Additional information was provided by the surgeon who indicated there was no product defect and the issue was due to his procedural technique which caused aspiration of ocular viscoelastic device (ovd) without injection of infusion when the handpiece was placed in the eye.In addition, he reported this was the third of five procedures and both, the thermal burn and corneal edema, were not serious / resolved the surgeon indicated the vision did not improve immediately after the procedure but has since recovered without any problems.

• 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: 11003899
• MDR Text Key: 222021567
• Report Number: 1644019-2020-00684
• Device Sequence Number: 1
• Product Code: LRO
• 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,Followup
• Report Date: 07/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2022
• Device Catalogue Number: 8065752182
• Device Lot Number: 2368629H
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CENTURION VISION SYSTEM; PHACO TIP