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

Catalog Number	8065752192
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A customer reported a fluidics management system (fms) pack received with a damaged phacoemulsification tip.The phacoemulsification tip was noted to be curved in an unusual way prior to patient contact during calibration of cataract surgery (with intraocular lens implant).The surgery was completed with another fluidics management system (fms) pak.There was no patient impact.
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
One opened phacoemulsification (phaco) tip, without a wrench, tapped to the label part of the of the tray was received.The returned sample was visually inspected and was found to be non-conforming as the phaco tip was bent above the aspiration bypass (ab) hole.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.Photos were reviewed by the manufacturing site.Photo 1 shows a pak label, the reported product and lot information is confirmed.Photo 2 shows a phaco tip with a bent cannula.The reported issue is confirmed from the photo review.The exact root cause could not be determined from the investigation performed.The returned sample is visually non-conforming with the phaco tip bent; therefore, a bent phaco tip was confirmed; however, how and when the phaco tip became bent could not be determined.Most likely root cause is handling during placement of the phaco tip onto the handpiece.The exact root cause for the bent phaco tip is unknown, therefore specific action with regards to this complaint cannot be taken.All phaco tips are 100% visually inspected by trained operators using 30x magnification during the manufacturing process.Any nonconformance, such as the phaco tip cannula bent exhibited on the returned opened sample, 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 further actions are required.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: 21642856
• Report Number: 1644019-2025-00738
• Device Sequence Number: 7662304
• Product Code: LRO
• UDI-Device Identifier: 00380657521920
• UDI-Public: (01)00380657521920(17)260930(11)241026(10)1744XR
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K880961
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/17/2025

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: 09/30/2026
• Device Catalogue Number: 8065752192
• Device Lot Number: 1744XR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/26/2025
• Supplement Date Received by Manufacturer: 05/27/2025
• Initial Report FDA Received Date: 03/19/2025
• Supplement Report FDA Received Date: 06/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/26/2024
• 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