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

Catalog Number	8065000133
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/03/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A customer reported that the balanced tip was broken inside a patient's eye and all pieces were removed during sculpt mode of the cataract extraction with intraocular lenses implant procedure.The fragment was never loose inside the eye and it stayed inside the irrigation sleeve.The surgery was completed after replacing the product with new one.There was no patient harm.
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.A sample was not received at the manufacturing site for evaluation for the report; however, the attached customer picture confirms the reported issue of broken phaco tip.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 report of the broken phaco tip is confirmed based on the picture attached to the parent complaint.However, because a sample was not received at the manufacturing site and the device history record review of the lot number provided indicated the product was released to the product¿s acceptable criteria, the root cause for customer complaint issue of broken tip cannot be determined.The exact root cause for this complaint is unknown, therefore, specific action with regards to this complaint cannot be taken.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.No adverse trends have been observed associated with the reported product and event.No additional action is required at this time.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
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: 19371604
• Report Number: 1644019-2024-01067
• Device Sequence Number: 7703774
• Product Code: LRO
• UDI-Device Identifier: 00380650001337
• UDI-Public: (01)00380650001337(17)251231(11)240109(10)16EJKH(21)NA
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K880961
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/27/2024

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: 12/31/2025
• Device Catalogue Number: 8065000133
• Device Lot Number: 16EJKH
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/03/2024
• Supplement Date Received by Manufacturer: 08/04/2024; 08/30/2024
• Initial Report FDA Received Date: 05/22/2024
• Supplement Report FDA Received Date: 08/30/2024; 09/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/09/2024
• 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