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)
Health Effect - Clinical Code	Intraocular Pressure Decreased (4468)
Date of Event	11/18/2024
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 nurse reported that the phacoemulsification fluid management system package had leaked liquid, the fluid flow of most products was blocked or even absent, resulting in abnormal anterior chamber during surgery and increased surgical risks.The surgery was completed after replacing the product with another one.There was no information about patient harm.The procedure type was unknown.
Additional Manufacturer Narrative
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.Six used and two unused fluidics management system (fms) paks were returned and inspected.The two unused packs were tested and met specifications with no leakage or occlusion observed.1 of the 6 used fms cassettes also was tested and met specifications.Irrigation and aspiration pressure was measured and met specifications for these 3 cassettes.5 of the 6 used fms cassettes generated system message 161 indicating a vacuum check error.The drip chambers were replaced and the samples retested and could pass priming and calibration successfully.The drip chambers were tested for leakage and no leakage was observed.The investigation was able to isolate the malfunction to the drip chamber, however, it was noted the condition of the cassettes were consistent with reuse although this cannot be confirmed.The customer should be remined these are single-use devices designed for one surgical procedure on one patient.The drip chamber is manufactured by an approved supplier.The most likely root cause of the customer¿s complaint is related to an error that occurred during the supplier¿s manufacturing process.The supplier manufacturer has been notified and made aware of this complaint issue.No further action will be taken for this occurrence.Based on our current tracking, there are no adverse trends for this reported complaint and lot.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: 20900642
• Report Number: 1644019-2024-02998
• Device Sequence Number: 13020074
• 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): 04/16/2025

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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/18/2024
• Supplement Date Received by Manufacturer: 03/21/2025
• Initial Report FDA Received Date: 12/11/2024
• Supplement Report FDA Received Date: 04/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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