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

Catalog Number	8065752192
Medical Device Problem Codes	Signal Artifact/Noise (1036); Defective Device (2588); Suction Failure (4039)
Health Effect - Clinical Code	Eye Burn (2523)
Date of Event	07/21/2022
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 customer reported a cassette malfunction which led to temporal wound burn, the handpiece was unable to aspirate upon initiating the phacoemulsification (phaco) and delivery ultrasound energy during the cataract procedure.Whitening of viscoelastic was also noted with occlusion sounding on phaco which immediately ceased.The temporal wound burn was noted and copious irrigation with balance salt solution (bss) applied.The cassette was replaced with a new one and once again primed with the same handpiece and now the procedure was completed successfully.Additional information was received confirming wound burn as corneal burn.
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 wet fms (fluidics management system) in a tray was visually inspected.The vent spike was cut off the administration line in the returned condition.A lab stock vent spike was used to perform functionality testing.The sample was tested using a console.The sample could be recognized by the console.The sample primed and tuned with the handpiece and the 0.9mm abs (aspiration bypass) tip and infusion sleeve from lab stock, successfully and the service data could be retrieved.The sample functioned within specification.Aspiration and irrigation rates met specifications.The root cause of the customer's complaint could not be established; the returned sample 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: 15174069
• Report Number: 1644019-2022-00648
• Device Sequence Number: 6269925
• Product Code: LRO
• UDI-Device Identifier: 00380657521920
• UDI-Public: 00380657521920
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/27/2022

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: 07/31/2023
• Device Catalogue Number: 8065752192
• Device Lot Number: 2512820H
• 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: 07/21/2022
• Supplement Date Received by Manufacturer: 12/05/2022
• Initial Report FDA Received Date: 08/05/2022
• Supplement Report FDA Received Date: 12/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/26/2021
• 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