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

Catalog Number 8065752485

Device Problems Overheating of Device (1437); Device Displays Incorrect Message (2591)

Patient Problem Eye Burn (2523)

Event Date 11/12/2020

Event Type  Injury  

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 during the sculpt phase of a cataract extraction procedure the patient experienced a corneal burn.System messages were noted during priming of the handpiece.The handpiece had too much ultrasound in respect to its settings and the tip got hot.There was a wound gap that required sutures for closure.The patient does have corneal opacity and astigmatism.This is one of three reports from this facility for the reported event above.

Manufacturer Narrative

A sample was not received at the manufacturing site for evaluation for the report of very hot tip, corneal burn, wound leakage, opacity and astigmatism; therefore, the condition of the product could not be verified.No lot number was identified with this complaint; therefore, a device history record review could not be conducted.A sample was not received at the manufacturing site and no lot information was provided; therefore, the root cause for the customer complaint issue cannot be determined.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
• MDR Report Key: 10955165
• MDR Text Key: 219923009
• Report Number: 1644019-2020-00659
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 8065752485
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CENTURION ACTIVE SENTRY HANDPIECE; CENTURION ACTIVE SENTRY SYSTEM
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR