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 Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/10/2025
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 phacoemulsification tip bent before the surgery.The procedural type was unknown.The surgery completion and replacement details were unknown.There was no information about patient impact.
Event or Problem Description
Additional information was received and confirmed that there was no contact with the patient.
Additional Manufacturer Narrative
Corrected information was updated in b.5 and h.6.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 and tip wrench in a small parts tray (smpt) was received for the report.The returned sample was visually inspected and was found to be non-conforming with cannula of the phaco tip was bent above the aspiration bypass (ab) hole.A nick with bent back metal at the bevel with tool marks at nicked area was also observed.No wear was observed.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 non-conformance review of the reported lot number.No deviations were identified and all corresponding production release specifications defined in the device master record were met.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.All phaco tips are 100% visually inspected by trained operators using 30x magnification during the manufacturing process.Any nonconformance is removed from the lot and scrapped.Complaint data for all company 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: 24033687
• Report Number: 1644019-2026-00234
• Device Sequence Number: 16049345
• Product Code: LRO
• UDI-Device Identifier: 00380657529179
• UDI-Public: (01)00380657529179(17)270331(11)250430(10)17D5X5
• 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,Followup
• Report Date (Section B): 05/13/2026

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: 17D5X5
• 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: 12/16/2025
• Supplement Date Received by Manufacturer: 01/12/2026; 04/21/2026
• Initial Report FDA Received Date: 01/12/2026
• Supplement Report FDA Received Date: 02/09/2026; 05/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/30/2025
• 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