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

Catalog Number	8065752181
Medical Device Problem Code	Suction Failure (4039)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/07/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A physician reported that aspiration failure occurred during ultrasound (us) mode, during cataract surgery (with intraocular lens implant).The surgery was completed after replacing the product with another 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
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.A used active fluidics management system (fms) in a tray was visually inspected and was tested using a console.The sample could be recognized by the console.The sample primed and tuned with the handpiece and the 0.9 millimeter abs (aspiration bypass system) tip and infusion sleeve from lab stock, successfully and the service data could be retrieved.No system message code displayed on console screen.Cassette max vacuum and aspiration flow rate, and irrigation flow rate were measured and met specifications.No problem was found with the returned cassette fluidics.Although the sample met specifications, the root cause of complaints investigated for message code was inconclusive.The most likely root cause is suspected to be operator error during socket bonding due to inadequate process set-up.Action was taken to determine root cause and implement corrective actions based on an observed trend for complaints of a similar nature.No patient risk is associated with message code as the error occurs during the priming and calibration of the cassette.To address root cause of system message code occurring during the vacuum test stage/priming test sequence, two corrective actions were initiated.¿ the first corrective and preventative action was to implement methods to increase drying/curing time after socket bonding and prior to testing on pods ¿ the second is to update the procedure after the first corrective action is completed.Complaints are reviewed and will be continued to be monitored at regular intervals for adverse trends.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: 18308325
• Report Number: 1644019-2023-01828
• Device Sequence Number: 12290940
• Product Code: LRO
• UDI-Device Identifier: 00380657521814
• UDI-Public: 00380657521814
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/11/2024

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: 10/31/2024
• Device Catalogue Number: 8065752181
• Device Lot Number: 155HFV
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/09/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/16/2023
• Supplement Date Received by Manufacturer: 02/15/2024
• Initial Report FDA Received Date: 12/12/2023
• Supplement Report FDA Received Date: 03/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/03/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CENTURION VISION SYSTEM
• Patient Sex: Unknown