MAUDE Adverse Event Report: ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER CENTURION VISION SYSTEM (ACTIVE SENTRY); UNIT, PHACOFRAGMENTATION

Catalog Number 8065753057

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Eye Burn (2523); Eye Pain (4467)

Event Date 02/06/2023

Event Type  Injury  

Event Description

A healthcare professional reported that during a cataract surgery a patient experienced corneal burn during the phacoemulsification step and had eye pain.The surgeon placed an amniograft to seal the wound on the eye during the same day of surgery.An ophthalmic operating console gave an occlusion bell during the procedure.The patient's eye status was improving.No further procedures have been scheduled but the patient will be monitored.This report is for the ophthalmic operating console involved in the event.

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).

Manufacturer Narrative

Service history was reviewed for the system.No service record relevant to the complaint reported event was found.However, the system was last serviced prior to the reported event.The service record (sr) was for installation of the system.The system found to meet all cosmetic and performance standards a non-conformance-based review of the batch/lot/serial number was performed and did not reveal any potential contributing factors to the reported complaint.A manufacturing device history record (dhr) review was performed prior to product release to ensure that the product was manufactured in compliance with the device master record.Based on the assessment, the product met release criteria.A review for complaints reported against this serial number was performed.No similar complaints were reported for the product serial under investigation.Based on the information obtained, the root cause of the reported event can be attributed to use error related to surgical technique, as the surgeon was not familiar with the functionality of the system.The surgeon continued to apply phaco after occlusion tones sounded and multiple trainings on the system.Manufacturers 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 VISION SYSTEM (ACTIVE SENTRY)
• Type of Device: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER; 15800 alton parkway; irvine CA 92618
• Manufacturer (Section G): ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER; 15800 alton parkway; irvine CA 92618
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 16596334
• MDR Text Key: 311818639
• Report Number: 2028159-2023-00333
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161794
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 8065753057
• Device Lot Number: 1566U9
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/06/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/11/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: ACTIVE SENTRY HANDPIECE.
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 68 YR
• Patient Sex: Male