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

Catalog Number	8065752182
Medical Device Problem Code	Suction Problem (2170)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information provided in d.9., h.3., h.6.And h.11.A wet fluid management system in a tray was visually inspected and was tested using a console.The product could be recognized and the service data could be retrieved from the console.However, the product failed to prime and generated a system message code.A leak was found at the aspiration luer fitting.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 received, the root cause of the no suction report which resulted in system message code was determined to be a leak found at the aspiration luer fitting.The broader investigation looking into the global trend associated with system message code reports was not able to assign a commonly shared root cause due to the variety of findings from multiple associated product evaluations.A number of potential contributing factors have been identified and are listed below.The broader investigation identified potential contributing factors that were associated with the global system message trend.These factors 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 fluid management systems.Preventive: update fluid management systems 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 trending and take further action, as appropriate.Consumables manufacturing management has been made aware of this complaint through the consumer affairs review meeting.The manufacturer internal reference number is: (b)(4).
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 there was no suction in the fluid management system during ultrasound mode of cataract surgery.The procedure type was unknown.The procedure was completed on the same day by replacing with similar product.There was patient contact but no impact to the patient.

• 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: 24220681
• Report Number: 1644019-2026-00595
• Device Sequence Number: 15475151
• Product Code: LRO
• UDI-Device Identifier: 00380657521821
• UDI-Public: (01)00380657521821(17)270131(11)250222(10)178W8K
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/29/2026

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: 8065752182
• Device Lot Number: 178W8K
• 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: 01/06/2026
• Supplement Date Received by Manufacturer: 04/07/2026
• Initial Report FDA Received Date: 01/30/2026
• Supplement Report FDA Received Date: 04/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/22/2025
• 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