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

Catalog Number	8065752081
Medical Device Problem Code	Suction Failure (4039)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/19/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A customer reported that there was no vacuum occurred during the cataract surgery.The surgery was completed after replacing the cassette.There was patient contact but 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.The sample was not received at the investigating site for this complaint report; visual inspection or functional testing could not be conducted.If a sample is returned at a later date, the investigation will be reopened, and the sample evaluated.The root cause of the customer's complaint could not be determined as a sample was not returned.As the root cause is unknown, the relationship, if any, of the device to the reported incident cannot be determined; however potential root causes are listed.The system operator's manual provides the following in regard to loss of aspiration/suction issues: insufficient aspiration.Probable cause: 1.Loose blue luer fittings.2.Damaged o-ring (ultra flow irrigation aspiration (i/a) handpiece only).3.Clogged tip.4.Kinked or damaged tubing.5.Cracked blue fitting.Recommended solutions: 1.Reconnect securely 2.Inspect o-ring and replace, as necessary.3.Flush tip with sterile water or balanced salt solution (bss) sterile irrigation solution.Retest.Replace tip.Retest.4.Check tubing and/or replace fluidics management system (fms).5.Check fitting and/or replace fms.After the investigation of this complaint, it has been determined that no action will be taken at this time as a sample was not returned.No adverse trends have been observed associated with the reported product and event.Quality assurance will continue to monitor customer complaints via the complaint review and will take action for any future occurrences as is deemed necessary.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 fluidics management system (fms) was visually inspected and was tested using an console.The fms primed and tuned with the handpiece, a 0.9-millimeter (mm) aspiration bypass system (abs) tip and infusion sleeve from lab stock successfully.Cassette maximum vacuum and aspiration flow rate was measured and met specifications.No problem was found with the returned cassette fluidics.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: INFINITI 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: 17332614
• Report Number: 1644019-2023-00895
• Device Sequence Number: 20485082
• Product Code: LRO
• UDI-Device Identifier: 00380657520817
• UDI-Public: 00380657520817
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: K880961
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/14/2024

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: 12/31/2023
• Device Catalogue Number: 8065752081
• Device Lot Number: 146K7E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/19/2023
• Supplement Date Received by Manufacturer: 09/15/2023; 12/20/2023
• Initial Report FDA Received Date: 07/17/2023
• Supplement Report FDA Received Date: 10/11/2023; 01/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/06/2022
• 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
• Patient Age: 71 YR
• Patient Sex: Male