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

Catalog Number	8065752180
Medical Device Problem Code	Suction Problem (2170)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/22/2025
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 healthcare professional reported that aspiration error occurred during cataract surgery (with intraocular lenses implant).The surgery was completed after replacing the product with another one.There was no information about patient impact.
Additional Manufacturer Narrative
Product evaluation was not able to be performed since the reported product was not received at the investigation site for evaluation.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, the investigation was unable to conclusively identify the root cause or origin of the reported event.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 not being returned to the manufacturing site for testing.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).
Additional Manufacturer Narrative
Additional information provided in d.9., h.3., h.6.And h.11.One fluidics management system (fms) in the tray was visually inspected, and no obvious defects were observed.The drain bag was detached from the drain bag tape on the cover of the cassette due to saturation.The drain bag tape was securely adhered on the cover.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 with the current software procedure.The product could be recognized by the console.The product primed and tuned with the handpiece and the 0.9-millimeter aspiration bypass system (abs) tip and infusion sleeve from the lab stock successfully and the service data could be retrieved.No system message code displayed on console screen and no occlusion found.Cassette max vacuum and aspiration flow rate, and irrigation flow rate were measured and met specifications.No problem was found with the returned cassette fluidics.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.The root cause of the customer's complaint could not be established; the returned sample functioned per specifications.No contributing factors could be identified that could cause the customer¿s experience.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).

• 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: 23299173
• Report Number: 1644019-2025-04020
• Device Sequence Number: 4798090
• Product Code: LRO
• UDI-Device Identifier: 00380657521807
• UDI-Public: (01)00380657521807(17)270228(11)250305(10)179HLR
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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,Followup
• Report Date (Section B): 01/06/2026

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: 8065752180
• Device Lot Number: 179HLR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/22/2025
• Supplement Date Received by Manufacturer: 10/22/2025; 12/10/2025
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 11/17/2025; 01/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/05/2025
• 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