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

Catalog Number	8065752217
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Intraocular Pressure Decreased (4468)
Date of Event	06/19/2024
Type of Reportable Event	Serious Injury
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 error code displayed resulting in sudden anterior chamber collapse and the infusion volume was very slow or even did not produce water, which cannot reach the required infusion pressure during surgery.The procedure type was unknown.The surgery was completed after replacement of new product.The patient had no adverse reactions after surgery.
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.One wet and one unused fluidics management system (fms) in a tray was visually inspected.A wet sample drain bag was detached from the drain bag tape on the cover due to saturation.The drain bag tape was adhered on the cassette properly.The aspiration, irrigation manifolds and drip chamber were cut off in the returned condition.Used lab stock manifolds and drip chamber to perform functionality testing.An unused sample, the manifolds and luers were intact.The samples were tested using a system console.The samples could be recognized by the console.The samples primed and tuned with a sentry handpiece and a 0.9mm abs tip and infusion sleeve from lab stock, successfully and the service data could be retrieved.No system message code displayed on console screen.Both cassettes max vacuum and aspiration flow rates, and irrigation flow rates were measured and met specifications.No problem was found with the returned cassettes fluidics.The root cause of the customer's complaint could not be established; the returned samples functioned per specification.This complaint has been reviewed and it is determined that no further actions will be pursed at this time as the sample met specifications.Based on our current tracking, there are no adverse trends for this reported complaint.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: 19708485
• Report Number: 1644019-2024-01508
• Device Sequence Number: 17883765
• Product Code: LRO
• UDI-Device Identifier: 00380657522170
• UDI-Public: (01)00380657522170(17)260131(11)240209(10)16J63J(21)NA
• 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): 10/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2026
• Device Catalogue Number: 8065752217
• Device Lot Number: 16J63J
• 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: 06/19/2024
• Supplement Date Received by Manufacturer: 10/03/2024
• Initial Report FDA Received Date: 07/10/2024
• Supplement Report FDA Received Date: 10/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/09/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown