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

Catalog Number 8065751763

Device Problem Operating System Becomes Nonfunctional (2996)

Patient Problem Capsular Bag Tear (2639)

Event Date 01/25/2024

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 nurse reported that during cataract surgery the patient experienced posterior capsule rupture.The physician proceeded with anterior vitrectomy due to with an ophthalmic probe due to posterior capsule rupture.At the end of the anterior vitrectomy procedure advisory messages were appeared and nurse continued by closing without noticing the advisory messages.The vitrectomy probe stopped working and a warning message for the pump appeared.The anterior vitrectomy step was not available as the console was not functional and did not have the option to do the calibration after opening new ophthalmic probe.The calibration steps were still not available even after the restart of console.

• Brand Name: CENTURION VISION SYSTEM
• 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: 18674373
• MDR Text Key: 334947481
• Report Number: 2028159-2024-00201
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• Reporter Country Code: CY
• PMA/PMN Number: K121555
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8065751763
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/26/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/24/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: CENTURION ULTRAVIT PROBE PROCEDURE PAK; CENTURION ULTRAVIT PROBE PROCEDURE PAK
• Patient Outcome(s): Required Intervention; Other
• Patient Age: 79 YR
• Patient Sex: Male