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

Catalog Number	8065752918
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	03/12/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A nurse reported that the balanced phacoemulsification tip broke during the lens emulsification portion of cataract surgery with intraocular lens implantation.A metal piece of the tip became dislodged inside the patient's eye.The surgeon had to widen the wound to remove the broken tip and used sutures to close the wound due to its size.The surgery was completed on the same day, and the patient¿s symptoms are being monitored frequently.
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).
Additional Manufacturer Narrative
No technical inquiries were received from the customer.One opened phaco tip without a wrench, in a bag was received for the report.The returned sample was visually inspected and was observed to be broken in two pieces at the aspiration bypass hole and the breakage was very jagged.The wall thickness was observed to be even.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 was unable to identify the root cause or origin of the reported event.The complaint evaluation confirms the phacoemulsification tip was broken.The root cause for the broken phacoemulsification tip cannot be determined from this evaluation.Additionally, no manufacturing-related deficiencies were found that potentially could have contributed to the complaint.As the root cause and its origin are inconclusive, further investigative or manufacturing actions are not warranted at this time.All phacoemulsification tips are 100% visually inspected by trained operators using 30 times magnification during the manufacturing process.Receipt of additional relevant information or supporting materials will prompt a re-evaluation of the complaint investigation.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: 21772618
• Report Number: 1644019-2025-00899
• Device Sequence Number: 12817173
• Product Code: LRO
• UDI-Device Identifier: 00380657529186
• UDI-Public: (01)00380657529186(17)260630(11)240721(10)16YK6W
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/11/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2026
• Device Catalogue Number: 8065752918
• Device Lot Number: 16YK6W
• 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: 03/11/2025
• Supplement Date Received by Manufacturer: 08/04/2025
• Initial Report FDA Received Date: 04/04/2025
• Supplement Report FDA Received Date: 08/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/21/2024
• 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
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Unknown