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

Catalog Number	8065752216
Medical Device Problem Codes	Complete Blockage (1094); Leak/Splash (1354); No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/15/2024
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 (b)(3).
Event or Problem Description
Nurse reported that products had blockage or even no fluid flow, resulting in abnormal anterior chamber and increasing surgical risks during the surgery.The procedure type was unknown, the surgery was completed after replacing the product with another one.There was no patient harm.
Additional Manufacturer Narrative
Additional information provided in h.6.And h.11.A review of the device history record traceable to the reported lot number indicates that the product was processed and released according to the product¿s acceptance criteria.It's important to remind the customer the fluidic management system (fms) cassette directions-for-use states during setup "good clinical practice dictates the testing for adequate irrigation and aspiration flow prior to entering the eye." no sample has been returned for evaluation; therefore, the condition of the product could not be verified.There was also no specific images or evidence provided to ascertain causality and confirm this reported event.Receipt of complaint sample or additional information pertinent to this complaint will result in re-evaluation of the complaint investigation.The root cause of the customer's complaint could not be conclusively determined as a sample was not received and the condition of the product could not be verified.As the root cause is unknown, the relationship, if any, of the device to the reported incident cannot be determined.The root cause for this complaint is not known, therefore, specific action with regards to this complaint cannot be taken.Current tracking indicates no adverse trend for this lot for this event.Before release from manufacturing, each final pack must pass quality testing and inspection confirming that the unit meets all product specifications.Quality assurance has reviewed this complaint and will continue to monitor data for evidence of adverse trending and take further action, as appropriate.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: 20681785
• Report Number: 1644019-2024-02708
• Device Sequence Number: 7229800
• Product Code: LRO
• UDI-Device Identifier: 00380657522163
• UDI-Public: (01)00380657522163(17)251231(11)240119(10)16FAFM
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 02/10/2025

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: 12/31/2025
• Device Catalogue Number: 8065752216
• Device Lot Number: 16FAFM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/16/2024
• Supplement Date Received by Manufacturer: 01/16/2025
• Initial Report FDA Received Date: 11/14/2024
• Supplement Report FDA Received Date: 02/10/2025
• Date Device Manufactured: 01/19/2024
• 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