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	Insufficient Information (4580)
Date of Event	10/27/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A non-conformance based review of the batch/lot/serial number was performed and did not reveal any potential contributing factors to the reported complaint.A manufacturing device history record (dhr) review was performed prior to product release to ensure that the product was manufactured in compliance with the device master record.Based on the assessment, the product met release criteria.A review for complaints reported against this lot/batch/serial number was performed.No similar complaints were reported for the product lot/batch/serial under investigation.A review for service records relevant to the reported complaint was performed.No service records relevant to the reported complaint were found.No photo(s) and/or video(s) was provided for evaluation by the reporter and a sample was not received at the investigation site for evaluation.The reported complaint was evaluated and does not meet criteria for reporting per applicable medical device regulations, does not meet criteria for a critical event, and a customer response was not requested.A review of production information, complaint history, and servicing (as applicable) was performed and did not reveal any potential contributing factors to the complaint.A complaint sample, photo, and/or video was not provided for evaluation.Based on the investigation, a failure of the device, labeling, or packaging to meet specifications could not be confirmed.Quality assurance has evaluated and investigated this complaint.Complaints are reviewed and monitored for adverse trends on a monthly basis and company will continue to monitor data for evidence of adverse trending and take further action, if appropriate.Receipt of complaint sample or additional information pertinent to this complaint will result in re-evaluation of the complaint investigation.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 health care professional reported that fluidics management system (fms) had no ultrasound during cataract surgery (with intraocular lens implant).The procedure was completed by replacing the product with new one.There was patient contact with suspect product but no information was reported about patient impact.

• 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: 24739689
• Report Number: 1644019-2026-01766
• Device Sequence Number: 21394427
• Product Code: LRO
• UDI-Device Identifier: 00380657522019
• UDI-Public: (01)00380657522019(17)270430(11)250510(10)17DMKR
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/31/2026

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: 17DMKR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/05/2026
• Initial Report FDA Received Date: 03/31/2026
• Date Device Manufactured: 05/10/2025
• 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.; CENTURION VISION SYSTEM.
• Patient Sex: Unknown