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

Catalog Number	8065000331
Medical Device Problem Codes	Suction Problem (2170); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A customer reported that lost vacuum multiple times during surgery.The procedure type was unknown.The surgery was completed by replacing with new cassette.There was no patient impact.This report pertains to cassette involved in this reported event.
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
The sample was not received at the investigating site for this complaint report; visual inspection or functional testing could not be conducted.Clinical information review: it was reported during a case where the demo unit was being used, where there was a loss in ¿vacuum mode¿ multiple times before and after reported cassette.System messages (sm) displayed which gave the instructions to replace the items.The case was completed without patient harm.Additional related information was not provided.Operators manual offers informant on this issue: in aspiration flow mode, the console uses the peristaltic pump.Suction panel in flow mode one vacuum power toggle ¿ enables or disables the suction function.Two intelligent aspiration icon ¿ indicates whether intelligent aspiration is on or off.Three vacuum parameter ¿ opens the vacuum dialog box.Four aspiration flow parameter ¿ opens the aspiration flow dialog box when selected.Note: the aspiration flow dialog box includes an additional toggle for intelligent aspiration.Turn on intelligent aspiration to display aspiration flow as zero or near zero when the vacuum limit is set to 700+ and full occlusion is detected.Five message ¿ indicates if there is an occlusion, reflux, or vent issue.Note: l always monitor the fill state of the fluidics management system (fms) drain bag during operation.L during aspiration, ensure the fms aspiration line does not have bubbles.L if the system has low flow, release the treadle.L when the vacuum feature is enabled, the tone generated by the console varies in pitch relative to vacuum strength.For instance, a higher pitch may indicate a flow restriction.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).

• Brand Name: UNITY TOTAL PLUS POSTERIOR 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: 23025663
• Report Number: 1644019-2025-03357
• Device Sequence Number: 15878461
• Product Code: LRO
• UDI-Device Identifier: 00380650003317
• UDI-Public: (01)00380650003317(17)270228(11)250326(10)17AH53
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K880961
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/01/2025

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: 8065000331
• Device Lot Number: 17AH53
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/19/2025
• Supplement Date Received by Manufacturer: 11/07/2025
• Initial Report FDA Received Date: 09/11/2025
• Supplement Report FDA Received Date: 12/02/2025
• Date Device Manufactured: 03/26/2025
• 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