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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/27/2025
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 nurse reported that the balanced tip was crooked before cataract with intraocular lens implantation surgery.The surgery was completed on the same day after replacing the product with another one.There was no information about patient impact.
Additional Manufacturer Narrative
Additional information provided in d.9., h.3., h.6.And h.11.No technical inquiries were received from the customer.One opened phacoemulsification (phaco) tip and wrench loose in a bag was received.The tip was not within the wrench.The sample was visually inspected and found to be nonconforming with phaco tip is bent in a couple areas and no wear is present on the threads, back of flange, or nut corners.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 nonconformance review of the reported lot.Two non-conformances were found for phaco bent tip.These non-conformances could have potentially contributed to the reported event of bent phaco tip.The returned sample was found to be visually nonconforming with a bent phaco tip.How and when the phaco tip became bent could not be determined due to that the tip was loose in the bag without the protective wrench.However, because no wear was found on the threads a potential manufacturing related root cause could not be ruled out.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.As the root cause and its origin are inconclusive, further investigative or manufacturing actions are not warranted at this time.However, an investigation has been initiated to determine root cause of the bent phaco tip.Additionally, nonconformance investigations were initiated for the related nonconformances identified on the nonconformance report.All phaco tips are 100% visually inspected by trained operators using 30 times magnification during the manufacturing process.Any nonconformance is removed from the lot and scrapped.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: 23613703
• Report Number: 1644019-2025-04914
• Device Sequence Number: 9032058
• Product Code: LRO
• UDI-Device Identifier: 00380657529179
• UDI-Public: (01)00380657529179(17)270630(11)250730(10)17JR9T
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• 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): 01/19/2026

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 Catalogue Number: 8065752917
• Device Lot Number: 17JR9T
• 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: 10/28/2025
• Supplement Date Received by Manufacturer: 12/23/2025
• Initial Report FDA Received Date: 11/21/2025
• Supplement Report FDA Received Date: 01/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/30/2025
• 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