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

Catalog Number 8065752914

Device Problem Excess Flow or Over-Infusion (1311)

Patient Problem Capsular Bag Tear (2639)

Event Date 06/12/2023

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 physician reported that during a surgery while using a phacoemulsification handpiece and the fluidics management system (fms) pack there was a surge in perfusion and patient experienced capsule rupture.The surgery was completed without product replacement, and vitrectomy treatment for capsular rupture was performed by using another console.

Manufacturer Narrative

The product under investigation is not a serviceable device.Therefore, a service record review was not performed.However, a phaco handpiece (hp) was returned for testing on this investigation.A non-conformance-based review of the 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.The hp was received for testing on this investigation.A visual assessment of the returned sample revealed no nonconformities found.The hp was connected to a calibrated centurion.The handpiece was connected to dynamic tuning fixture (dtf) for stroke length testing on the longitudinal and torsional movements which found the handpiece to meet specifications.The handpiece was found to meet specifications.Therefore, the root cause of the reported event is 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, ACCESSORY, ACTIVE SENTRY HANDPIECE
• 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: 17255117
• MDR Text Key: 318373794
• Report Number: 2028159-2023-00943
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K161794
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8065752914
• Device Lot Number: 156YUN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/11/2023
• Initial Date FDA Received: 07/05/2023
• Supplement Dates Manufacturer Received: 09/12/2023
• Supplement Dates FDA Received: 10/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/28/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: CENTURION SURGICAL PROCEDURE PAK; CENTURION VISION SYSTEM
• Patient Outcome(s): Other; Required Intervention