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

Catalog Number	8065752193
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/02/2024
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 physician reported that the phacoemulsification tip was bent before cataract surgery.The procedure was completed by replacing the phacoemulsification tip with new one.There was no patient impact.
Additional Manufacturer Narrative
Additional information provided in d.9, h.3, h.6, and h.11.One opened phacoemulsification tip taped to a form in a tray was received for the report.Sample was visually inspected and found to be nonconforming.Phacoemulsification tip was bent in upward position & not in down position as per specifications.At bevel area tip was bent in with a scratch on cannula at bent in tip area.Wear on threads, back of flange, & nut corners consistent with threading on 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 that the phacoemulsification tip was bent in wrong direction.The root cause is a manufacturing related at the bevel process of phacoemulsification tips and was missed during downstream inspection.The complaint evaluation also observed that tip was bent in at bevel with a scratch on cannula at bent in tip area.How and when the phacoemulsification tip bevel became deformed cannot be determined from this evaluation.The most likely cause of a deformed tip is from improper handling of the product.An investigation was completed for the bevel of the phacoemulsification tip bent in wrong direction.All phacoemulsification tips are 100% visually inspected by trained operators using 30x magnification during the manufacturing process.Any nonconformance, such as the bent phacoemulsification tip exhibited on the returned opened sample, are removed from the lot and scrapped.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: 20564476
• Report Number: 1644019-2024-02521
• Device Sequence Number: 7988371
• Product Code: LRO
• UDI-Device Identifier: 00380657521937
• UDI-Public: (01)00380657521937(17)251031(11)231122(10)16C5XP
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K880961
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/12/2025

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: 10/31/2025
• Device Catalogue Number: 8065752193
• Device Lot Number: 16C5XP
• 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: 10/03/2024
• Supplement Date Received by Manufacturer: 02/16/2025
• Initial Report FDA Received Date: 10/30/2024
• Supplement Report FDA Received Date: 03/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/22/2023
• 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