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

Catalog Number	8065000138
Medical Device Problem Code	Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/05/2024
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 non healthcare professional reported that the phacoemulsification tip with metal shard in it during cataract surgery (with (iol) intraocular lens implant).The procedure was completed with use of another tip.There was no patient impact.
Additional Manufacturer Narrative
Additional information provided in d.9., h.3., h.6.And h.11.One opened phacoemulsification (phaco) tip without a wrench was received in a plastic container with lid from the report.The returned sample was visually inspected and was found to be non-conforming.The sample had raised metal inside the bevel and on the outside ledge of the bevel.Nicks were observed on the outside of the cannula's tip and the bevel surface.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.Photo attached to the file was reviewed by the manufacturing site.Photo is a screenshot of the initial reported issue with a photo of a pak label.Reported product and lot information is confirmed.The reported issue could not be confirmed from the photo review.The complaint evaluation confirms the phaco tip with metal shard for the reported complaint.The root cause is a manufacturing related as the bevel burr identified could have been missed during inspection.A non-conformance record has been completed for the issue of phaco tip with metal shard.All phaco tips are 100% visually inspected by trained operators using 30x magnification during the manufacturing process.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: 21032220
• Report Number: 1644019-2024-03191
• Device Sequence Number: 9133403
• Product Code: LRO
• UDI-Device Identifier: 00380650001382
• UDI-Public: (01)00380650001382(17)260731(11)240826(10)170YJU
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K880961
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/05/2025

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: 07/31/2026
• Device Catalogue Number: 8065000138
• Device Lot Number: 170YJU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/06/2024
• Supplement Date Received by Manufacturer: 04/11/2025
• Initial Report FDA Received Date: 12/29/2024
• Supplement Report FDA Received Date: 05/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/26/2024
• 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