MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HOUSTON UNITY CATARACT FMS PROCEDURE PACK; GENERAL SURGERY TRAY (KIT)

Catalog Number	8065000339
Medical Device Problem Codes	Suction Problem (2170); Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2026
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).H.10 reflects all related report numbers associated with this product event that have been submitted at this time.
Event or Problem Description
A nurse reported that priming was done without issue and completed phacoemulsification (phaco) part of surgery, followed by irrigation/aspiration (i/a).Subsequently, an error message indicating ¿fluidics not operational¿ was displayed.At this point, there was no irrigation or aspiration or vacuum or phaco available during cataract with intraocular lens implant surgery.Connected lines to test could see foot pedal being depressed but no fluidics.The handpiece and fluid management system (fms) was then removed.The system was powered down.The surgeon did not require i/a again to complete the case.After rebooting the system, the remaining of the procedure was completed without further issues.There was no impact to the patient.This report pertains to the cassette involved for this complaint.
Additional Manufacturer Narrative
Additional information provided in h.6.And h.11.The product was not received at the investigating site for this complaint report; visual inspection or functional testing could not be conducted.The customer did provide a photo of the console screen with a priming failed message; however, without the product we are unable to confirm root cause.The investigation conducted a non-conformance review of the reported lot number.No relevant deviations were identified, all corresponding production release specifications defined in the device master record were met.As the root cause and its origin are inconclusive, further investigative or manufacturing actions are not warranted at this time.Receipt of additional relevant information or supporting materials will prompt a re-evaluation of the complaint investigation.No further investigative or manufacturing actions are warranted at this time due to the product not being returned to the manufacturing site for testing.Receipt of additional relevant information or supporting materials will prompt a re-evaluation of the complaint investigation.Complaint data for all company products is reviewed monthly to monitor for adverse trends.During the last review, no adverse trends were observed for the reported product and event combination.Quality assurance has reviewed this complaint and will continue to monitor data for evidence of adverse trending and take further action, as appropriate.No further action warranted at this time.The manufacturer internal reference number is: (b)(4).H.10 reflects all related report numbers associated with this product event that have been submitted at this time.

• Brand Name: UNITY CATARACT FMS PROCEDURE PACK
• 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: 24554615
• Report Number: 1644019-2026-01411
• Device Sequence Number: 15819241
• Product Code: LRO
• UDI-Device Identifier: 00380650003393
• UDI-Public: (01)00380650003393(17)270131(11)250218(10)178UKA
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/29/2026

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 Catalogue Number: 8065000339
• Device Lot Number: 178UKA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/08/2026
• Supplement Date Received by Manufacturer: 05/01/2026
• Initial Report FDA Received Date: 03/10/2026
• Supplement Report FDA Received Date: 05/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/18/2025
• 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: UNITY VCS CONSOLE.
• Patient Sex: Unknown