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

Catalog Number	8065752216
Medical Device Problem Code	Incomplete or Inadequate Connection (4037)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/16/2025
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 customer reported via health authority that the handpiece could not pass the test and indicating that the phacoemulsification tip was loose before cataract with intraocular lens implantation surgery for the left eye.The surgery was completed on the same day after replacing the sterilization tip with a new one, then the handpiece test passed.There was no impact to the patient.This report pertains to the phacoemulsification tip involved in this complaint.
Additional Manufacturer Narrative
Additional information provided in h.6.And h.11.No technical inquiries were received from the customer.A sample was not received at the manufacturing site for evaluation; therefore, the condition of the product could not be verified.A review of the device history record traceable to the reported lot number, indicates that the reported product was processed and released according to the reported product¿s acceptance criteria.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 concluded that the root cause of the reported event is related to use error.The following factors outlined in the reported product¿s direction for use, there are warnings that instruct the user that tips are intended for one procedure only.Do not reuse or reprocess the device.Additionally, no manufacturing-related deficiencies were found that potentially could have contributed to the complaint.Since the cause of this complaint is due to user error, specific action with regards to this complaint cannot be taken.All phacoemulsification tips are 100% visually inspected by trained operators using 30x magnification during the manufacturing process.Any nonconformance is removed from the lot and scrapped.Complaints are reviewed and monitored at regular intervals for any significant adverse trends.No adverse trends have been observed associated with the reported product and event.No additional action is required at this time.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: 23814460
• Report Number: 1644019-2025-05518
• Device Sequence Number: 21184501
• Product Code: LRO
• UDI-Device Identifier: 00380657522163
• UDI-Public: (01)00380657522163(17)261031(11)241130(10)175U74
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K880961
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 03/18/2026

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: 8065752216
• Device Lot Number: 175U74
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/21/2025
• Supplement Date Received by Manufacturer: 02/23/2026
• Initial Report FDA Received Date: 12/16/2025
• Supplement Report FDA Received Date: 03/18/2026
• Date Device Manufactured: 11/30/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CENTURION VISION SYSTEM, ACCESSORY, HANDPIECE.
• Patient Age: 59 YR
• Patient Sex: Female