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

Catalog Number	8065752917
Medical Device Problem Code	Suction Problem (2170)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/29/2026
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 health care professional reported that encounter whitish content at sculpt mode and unable to phaco well during intraocular lens implantation surgery.The other surgery details were unknown.There was no information about any impact on patient.
Additional Manufacturer Narrative
Additional information provided in d.9., h.3., h.6.And h.11.One fluid management system (fms) cassette assembly was returned for evaluation.Inspection of the product found no obvious defects that would have contributed to the reported event.The fluid management system (fms) cassette was tested on a console, primed and tuned with the ultrasonic hand piece successfully and could achieve maximum vacuum.No system message was generated during functional testing.No fluid or air leaks, and no cracks were observed from the connectors.The irrigation and aspiration flow rates were measured and found to be within specifications.Fluid flowed from the balanced salt solution (bss) bottle through the irrigation path continuously, no fluidic anomalies were observed.No occlusion or obstruction was identified during inspection and functional testing.We were unable to replicate the customer's experience during laboratory evaluation.The investigation conducted a non-conformance review of the reported lot number.No deviation were identified that would have contributed to this event and all corresponding production release specifications defined in the device master record were met.Based on the evaluation of the information and materials received, the root cause of the customer's complaint could not be established, the returned product functioned per specifications.In the absence of a confirmed device malfunction and considering the customer¿s acknowledgement that the fluid management system (fms) cassette was not suspected to be causal, non-device factors cannot be excluded as potential contributors to the reported event.Based on the evaluation of the information and materials received, the product met specifications and therefore no corrective action is required.Before release from manufacturing, every pack batch must pass quality testing and inspection confirming that the batch meets all product and packaging specifications.Complaint data for all products is reviewed monthly to monitor for adverse trends.During the last review, no adverse trends were observed for the reported product and event combination.Quality assurance has reviewed this complaint and will continue to monitor data for evidence of adverse trending and take further action, as appropriate.No further action warranted at this time.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: 24413672
• Report Number: 1644019-2026-01058
• Device Sequence Number: 5879615
• Product Code: LRO
• UDI-Device Identifier: 00380657529179
• UDI-Public: (01)00380657529179(17)270731(11)250829(10)17LJPD
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/27/2026

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: 8065752917
• Device Lot Number: 17LJPD
• 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: 01/30/2026
• Supplement Date Received by Manufacturer: 03/26/2026
• Initial Report FDA Received Date: 02/23/2026
• Supplement Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/29/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CENTURION VISION SYSTEM, ACCESSORY, HANDPIECE.
• Patient Sex: Unknown