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

Catalog Number	8065752917
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/17/2025
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 physician reported that tip angle was different during the surgery.The procedural type was unknown.The surgery was completed on the same day after replacing the product with another one.There was no information about patient impact.
Event or Problem Description
Upon further assessment, it was confirmed that the reported mix product issue involving the ultrasound tip was attributable to the use of an incorrect item.
Additional Manufacturer Narrative
Corrected information was updated in b.2., b.5 and h.11.Upon further assessment, it was confirmed that the mix product issue involving the ultrasound tip was attributable to the use of an incorrect item.This event does not meet the criteria for reporting under the applicable regulations.Accordingly, no further reports will be submitted under manufacturer report number 1644019-2026-00286.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: 24050768
• Report Number: 1644019-2026-00286
• Device Sequence Number: 9420940
• Product Code: LRO
• UDI-Device Identifier: 00380657529179
• UDI-Public: (01)00380657529179(17)270731(11)250812(10)17L3U5
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K880961
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/22/2026

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 Catalogue Number: 8065752917
• Device Lot Number: 17L3U5
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/18/2025
• Supplement Date Received by Manufacturer: 04/10/2026
• Initial Report FDA Received Date: 01/13/2026
• Supplement Report FDA Received Date: 04/22/2026
• Date Device Manufactured: 08/12/2025
• 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