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

Catalog Number 8065753057

Device Problem Decrease in Suction (1146)

Patient Problem Vitreous Hemorrhage (2143)

Event Date 10/22/2021

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 healthcare professional reported that during a cataract/ vitrectomy combination surgery, an ophthalmic operating console had with no aspiration.The surgeon changed the anterior vitrectomy probe, and then operated after the connections and priming, the irrigation worked along with cutting, however there was no aspiration.The system was primed again but the issues were persisted.Movement of the flow of fluid or air bubbles in the aspiration tube was checked for but there was no issue found.There was no system occlusion tone heard.The second phacoemulsification console connected with probe and it worked without any issue.The vitrectomy was completed with the second console.The cortical mass was cleaned up and the aspiration of the healon was completed by first console with the irrigation/aspiration probe.The required procedure was completed on the same day.There was an intraocular bleed which tracked into the vitreous.There was a delay in completing the surgery as due to repeated priming and a change of console.The patient is being followed up for the vitreous hemorrhage.

Manufacturer Narrative

The company service representative examined the system and was unable to confirm or replicate the reported event.The system was then tested and met all product specifications.A system 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.The system was found to meet specifications; therefore, the root cause of the reported events are inconclusive.Manufacturer 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: 12879858
• MDR Text Key: 281331967
• Report Number: 2028159-2021-01407
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K161794
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 8065753057
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/26/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other