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	11/21/2025
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).H.10 reflects all related report numbers associated with this product event that have been submitted at this time.
Event or Problem Description
A customer reported that while a cataract extraction surgery by phacoemulsification was initiated by physician, there was a lack in vacuum strength when using the handpiece, during the cortical phase (despite of screen indicating that the vacuum was increasing) and as well in the viscoelastic aspiration phase.For the next surgery, the equipment was restarted and the cassette was replaced and the problem was resolved.The surgery was completed on the same day.There was no impact to the patient.This report pertains to cassette involved in reported event.
Additional Manufacturer Narrative
Additional information provided in d.9., h.3., h.6.And h.11.The turbid fluidics management system in the tray was visually inspected.The drain bag was detached from the drain bag tape on the cover due to saturation.The drain bag tape was adhered on the cassette properly.Both irrigation and aspiration luers were intact.Flare shape was observed in the blue socket fitting at the aspiration tubing insertion end.The product was tested using the console software.The product could be recognized by the console.The product primed and tuned with the sentry handpiece and the 0.9 milli meter aspiration bypass system tip and infusion sleeve from the lab stock, successfully and the service data could be retrieved.No system message code displayed on console screen.Neither leakage, nor occlusion was detected from the tubing insertion to the fittings and the four aspiration ports on the pump region of the cassette base.The product functioned within specification.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 materials received, the investigation was unable to identify the root cause or origin of the reported event as the returned product met specifications.Additionally, no manufacturing-related deficiencies were found that potentially could have contributed to the complaint.No further investigative or manufacturing actions are warranted at this time due to the product meeting specifications.Receipt of additional relevant information or supporting materials will prompt a re-evaluation of the complaint investigation.Complaint data for all company 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).H.10 reflects all related report numbers associated with this product event that have been submitted at this time.

• 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: 23847281
• Report Number: 1644019-2025-05573
• Device Sequence Number: 9572375
• Product Code: LRO
• UDI-Device Identifier: 00380657521821
• UDI-Public: (01)00380657521821(17)270531(11)250602(10)17F6A5
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K880961
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/13/2026

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: 17F6A5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/24/2025
• Supplement Date Received by Manufacturer: 03/20/2026
• Initial Report FDA Received Date: 12/19/2025
• Supplement Report FDA Received Date: 04/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/02/2025
• 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.; CENTURION VS, ACCESSORY, CENTURION OZIL HP.
• Patient Sex: Unknown