MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HOUSTON CENTURION SURGICAL PROCEDURE PAK; GENERAL SURGERY TRAY (KIT)

Catalog Number	8065752201
Medical Device Problem Code	Suction Problem (2170)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/23/2025
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
A physician reported that aspiration failure occurred during surgery (unknown procedure type).The surgery was completed after replacing the product with another one.There was no patient impact.
Additional Manufacturer Narrative
Two turbid fluidics management system (fms) in trays were visually inspected and were tested using a console.The products could be recognized by the console.Product #1 primed and tuned with the sentry handpiece and the 0.9 milli meter aspiration bypass system tip and infusion sleeve from lab stock, successfully and the service data could be retrieved.Cassette maximum vacuum and aspiration flow rate, and irrigation flow rate were measured and met specifications.No problem was found with the returned cassette fluidics.Product #2 failed to prime and generated a system message code.A leak occurred at the aspiration tubing to cassette insertion due to a lack of solvent which created channeling between the wall of the cassette and the aspiration tubing.The investigation conducted a non-conformance review of the reported lot number.No deviations that could have contributed to this event were identified and all corresponding production release specifications defined in the device master record were met.Based on the evaluation of the information and product 2 received, the root cause of the system message code could not be conclusively confirmed.Based on the investigation findings, the root cause is unassignable.Product 2 failed, and product 1 met specifications.The broader investigation identified potential contributing factors that may influence the occurrence of system message that include variability in socket bonding performance and gaps in operator training related to the bonding process.An internal investigation was completed.Preventative action plans were initiated to address the contributing factors at the manufacturing site prior to june 2026.¿ preventive: create and implement on the job training documents that detail the precise process for socket bonding manifolds to fmss.¿ preventive: update fms modified atmosphere packaging (map) and techno ideal method of procedure (mop) to include the details outlined in the on-the-job training.Complaints are reviewed and will continue to be monitored at regular intervals for adverse trends.Quality assurance has reviewed this complaint and will continue to monitor data for evidence of adverse trends and take further action, as appropriate the manufacturer internal reference number is: (b)(4).

• Brand Name: CENTURION SURGICAL PROCEDURE PAK
• Common Device Name: GENERAL SURGERY TRAY (KIT)
• Manufacturer (Section D): ALCON RESEARCH, LLC - HOUSTON; 9965 buffalo speedway; houston TX 77054
• Manufacturer (Section G): ALCON RESEARCH, LLC - HOUSTON; 9965 buffalo speedway; houston TX 77054
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 24118451
• Report Number: 1644019-2026-00445
• Device Sequence Number: 15795582
• Product Code: LRO
• UDI-Device Identifier: 00380657522019
• UDI-Public: (01)00380657522019(17)270430(11)250525(10)17ET20
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K880961
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 8065752201
• Device Lot Number: 17ET20
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/25/2025
• Supplement Date Received by Manufacturer: 04/03/2026
• Initial Report FDA Received Date: 01/20/2026
• Supplement Report FDA Received Date: 04/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/25/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown