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

Catalog Number	8065752917
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/14/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A health care professional reported that small metal shard broke off phaco tip inside the eye and retinal forceps used to remove the shard during the intraocular implantation surgery.The surgery was completed on the same day after opening new pack.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
Additional information provided in h.6.And h.11.No technical inquiries were received from the customer.A sample was not received at the manufacturing site for evaluation for the report; therefore, the condition of the product could not be verified.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 photo attached was reviewed by the manufacturing site.The photos 1 shows, phaco tip inside wrench and pak lot number.Photo 2 shows phaco tip in the wrench with some material and photo 3 shows phaco material broke off from the phaco tip.Reported issue confirmed from photo 3.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 evaluation of the attached photo confirms the small metal shard broke off phaco tip.Based on the evaluation of the information, since the sample was not received at the manufacturing site, how and when the metal broke off from the phaco tip 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.All phaco tips are 100% visually inspected by trained operators using 30x magnification during the manufacturing process.Receipt of additional relevant information or supporting materials will prompt a re-evaluation of the complaint investigation 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: 24342207
• Report Number: 1644019-2026-00846
• Device Sequence Number: 9836337
• Product Code: LRO
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/25/2026

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: 17C5KW
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/09/2026
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/18/2026
• Supplement Date Received by Manufacturer: 04/30/2026; 09/03/2026
• Initial Report FDA Received Date: 02/16/2026
• Supplement Report FDA Received Date: 05/21/2026; 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/06/2025
• 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