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

Catalog Number	8065752183
Medical Device Problem Code	Ambient Noise Problem (2877)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2025
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 during the ultrasound mode of cataract surgery (with intra ocular lens implantation), there was an unpleasant noise coming from the cassette and roller area.The surgery was completed without product replacement.There was no impact to the patient.
Additional Manufacturer Narrative
Additional information provided in d.9., h.3., h.6.And h.11.One turbid fluidics management system in a tray was visually inspected and was tested using a console.The product could be recognized by the console.The product primed and tuned with a handpiece and a 0.9 millimeter aspiration bypass system tip and infusion sleeve from lab stock, successfully and the service data could be retrieved.No system message code displayed on console screen.No leakage or occlusion was detected from the tubing insertion to the fittings and the four aspiration ports on the pump region of the cassette base.No abnormal noise occurred during testing.From lab experience, noise occurs when there is excessive surgical residue in the aspiration fluid path of the tubing and the cassette, but it does not affect the functionality.The products functioned within specification.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.The investigation conducted a non-conformance review of the reported lot number.No deviations 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 alcon 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: 21665188
• Report Number: 1644019-2025-00798
• Device Sequence Number: 7755800
• Product Code: LRO
• UDI-Device Identifier: 00380657521838
• UDI-Public: (01)00380657521838(17)260531(11)240617(10)16VEUH
• 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): 06/18/2025

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 Expiration Date: 05/31/2026
• Device Catalogue Number: 8065752183
• Device Lot Number: 16VEUH
• 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: 02/26/2025
• Supplement Date Received by Manufacturer: 05/28/2025
• Initial Report FDA Received Date: 03/21/2025
• Supplement Report FDA Received Date: 06/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/17/2024
• 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