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

Catalog Number	8065000340
Medical Device Problem Codes	Suction Problem (2170); Infusion or Flow Problem (2964); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/05/2025
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 customer reported that cassette and handpiece passed prime when started to operate in chop mode an error message appeared and no fluidics, no vacuum, no phaco were available.The surgery was completed by changing the product.No patient impact was reported.This report pertains to cassette involved in this reported event.
Additional Manufacturer Narrative
Additional information provided in d.9., h.3., h.6.And h.11.Two paks were visually inspected and were tested using a console.The products could prime and tune with an handpiece, the returned tips and infusion sleeves successfully.No message code appeared on the screen.The sensor accuracy, aspiration and irrigation flow rates were tested and functioned per specification.The maximum vacuum level was measured and met specifications.The product met specification.No problem was found with the returned cassettes fluidics.The investigation conducted a non-conformance review of the reported lot number.No deviations that could have contributed to this event were identified and all corresponding production release specifications defined in the device master record were met.Based on the evaluation of the information and materials received, the investigation was unable to identify the root cause or origin of the reported event as the returned products met specifications.Additionally, no manufacturing-related deficiencies were found that potentially could have contributed to the complaint.No further investigative or manufacturing actions are warranted at this time due to the product meeting specifications.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: 22932638
• Report Number: 1644019-2025-03136
• Device Sequence Number: 18730446
• Product Code: LRO
• UDI-Device Identifier: 00380650003409
• UDI-Public: (01)00380650003409(17)261231(11)250127(10)177JP5
• 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,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/19/2025

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: 8065000340
• Device Lot Number: 177JP5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/05/2025
• Supplement Date Received by Manufacturer: 11/21/2025
• Initial Report FDA Received Date: 09/02/2025
• Supplement Report FDA Received Date: 12/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/27/2025
• 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