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

Catalog Number	8065000331
Medical Device Problem Code	Suction Failure (4039)
Health Effect - Clinical Code	Insufficient Information (4580)
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 non-health care professional reported that suction was failed during surgery.The procedure type was unknown.The surgery was completed by replacing another pack.There was no information about patient impact.
Additional Manufacturer Narrative
Additional information provided in d.9., h.3., h.6.And h.11.Corrected information was provided in h.6 (food and drug administration component code search).One opened probe was received, with a tip protector, in a tray.The sample was visually inspected and found to be nonconforming with orange/brown foreign material on the port face and slightly bent needle.The sample was then functionally tested for actuation and aspiration.The sample was found to be conforming for actuation and nonconforming for aspiration.The probe was disassembled and the components inspected.Nominal wear observed on inner cutter when compared to the degree of wear based on continuous actuation of the probe visual standard photos.Wear marks observed at bend area.The sample was tested with a syringe and resistance was felt.A wire was inserted through the aspiration path.The sample was retested with a syringe, and no resistance was felt.The sample was retested for aspiration with the probe driver and was able to aspirate.The initial aspiration test failed due to an interference in the aspiration path and once the interference was removed the probe was able to aspirate.A review of the device history record traceable to the lot number obtained from the device¿s radio frequency identification tag, indicates that the reported product was processed and released according to the reported product¿s acceptance criteria.The investigation conducted a non-conformance review of the reported lot number.No deviations 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.Additionally, no manufacturing-related deficiencies were found that potentially could have contributed to the complaint.The complaint evaluation confirms the probe had an aspiration failure.The root cause of the aspiration failure is an interference in the aspiration path once the interference was removed the probe was able to aspirate.However, the exact root cause of the interference could not be determined from the evaluation performed.As the root cause and its origin are inconclusive, further investigative or manufacturing actions are not warranted at this time as the probe sample was able to aspirate once the observed interference was removed.All probes are 100% visually inspected and tested for actuation, aspiration, and cut during manufacturing.Any non-conformances found are removed from the lot and scrapped.Receipt of additional relevant information or supporting materials will prompt a re-evaluation of the complaint investigation.Complaint data for all 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: 23862591
• Report Number: 1644019-2025-05635
• Device Sequence Number: 9386523
• Product Code: LRO
• UDI-Device Identifier: 00380650003317
• UDI-Public: (01)00380650003317(17)270228(11)250326(10)17AH5Y
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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): 04/20/2026

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: 8065000331
• Device Lot Number: 17AH5Y
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/25/2025
• Supplement Date Received by Manufacturer: 03/30/2026
• Initial Report FDA Received Date: 12/22/2025
• Supplement Report FDA Received Date: 04/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sex: Unknown