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 Rupture (2208); Intraocular Pressure Decreased (4468)

Event Date 10/19/2023

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 cataract surgery while using an ophthalmic system the patient experienced posterior capsular rupture on right eye and due to which vitrectomy was performed.The surgery was completed after extracapsular fixation of the lens and the patient's condition is improving.

Event Description

Additional information received and reported that patient also experienced the event anterior chamber instability.

Manufacturer Narrative

The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

The company representative was unable to confirm nor replicate the reported event.However, the fluidics module and ai module were both replaced as a preventive measure.Both were returned for testing on this investigation.The system was tested and found to meet product specifications.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.Potentially relevant complaints were found and reviewed as part of this investigation.The system was involved in separate reported events with different dates/patient identifiers, and these are captured.The investigations of all four complaints will mirror each other.The fluidics module and ai module were received for testing on this investigation.A visual assessment of the returned samples revealed no obvious non-conformities in either module.The fluidics module was installed into a calibrated system, and no system messages displayed at startup.The fluidics module passed the surgical test in sculpt mode 3 times consecutively and passed all functional tests.The module then passed surgical tests in sculpt mode for 5 minutes.Per customer request, an additional surgical test in sculpt mode was performed while occluding the suction line intentionally then opening again to see if the iop (intraocular pressure) function¿s recovery takes longer than normal.The pressure came back to normal immediately.The iop recovery time was the same when testing with a known working fluidics module.The ai module also passed the same functional tests when installed into the calibrated system.No system messages were observed at startup or when the balanced salt solution (bss) bag and cassette were inserted into the system/fluidics module.The ai module passed all required tests.The additional test request to check iop recovery was also performed while the ai module was installed.The pressure again went back to normal immediately and the iop recovery time was the same when testing with a known working ai module.The system and two of its components were 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 (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: 18308963
• MDR Text Key: 330222220
• Report Number: 2028159-2023-01664
• Device Sequence Number: 1
• Product Code: HQC
• UDI-Device Identifier: 00380657530571
• UDI-Public: 00380657530571
• 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,Followup
• Report Date: 02/20/2024

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: 8065753057
• Device Lot Number: 15LX7W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/15/2023
• Initial Date FDA Received: 12/12/2023
• Supplement Dates Manufacturer Received: 12/20/2023; 01/26/2024
• Supplement Dates FDA Received: 01/12/2024; 02/20/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/15/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other
• Patient Age: 67 YR
• Patient Sex: Male