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

Catalog Number	8065000134
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/07/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A nurse reported that the phacoemulsification (phaco) tip was broke off in the patient's eye but remained securely within the sleeve and did not come loose during the cataract [with intraocular lens (iol) implant] surgery.The phaco tip was removed during the same surgery without requiring the surgeon to remove the broken piece directly.The surgery was completed on same day by replacing the phaco tip.There was no impact on the patient.
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
Additional information provided in d.9., h.3., h.6.And h.11.One opened phacoemulsification (phaco) tip with part of phaco tip in wrench and other half of phaco tip was received in a plastic cup with lid.The returned phaco tip was visually inspected and was found to be non-conforming, broken at the cone to cannula transition area, and cracks on the cannula of both broken pieces.The back hole was concentric.Uneven wall thickness was observed on both broken pieces.Wear was observed on the threads, back of flange, and nut corners consistent with threading on a handpiece.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 complaint evaluation confirms the phaco tip is broken.The reason for breakage is due to a uneven wall thickness creating a weak region at the thinner section.The uneven wall thickness is a known potential risk with the phaco tip from the milling process.Manufacturing controls are already in place to minimize the creation of this defect.An investigation has been completed and a nonconformance record opened for this file is for the defect of uneven wall thickness of the phaco tip.All phaco tips are 100% visually inspected by trained operators using 30x magnification throughout the manufacturing process.Complaints are reviewed and monitored at regular intervals for any significant adverse trends.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: 20829523
• Report Number: 1644019-2024-02903
• Device Sequence Number: 11728174
• Product Code: LRO
• UDI-Device Identifier: 00380650001344
• UDI-Public: (01)00380650001344(17)260831(11)240929(10)172TNL
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K880961
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/22/2025

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: 08/31/2026
• Device Catalogue Number: 8065000134
• Device Lot Number: 172TNL
• 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: 11/07/2024
• Supplement Date Received by Manufacturer: 02/27/2025
• Initial Report FDA Received Date: 12/03/2024
• Supplement Report FDA Received Date: 03/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/29/2024
• 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