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

Catalog Number	8065000484
Medical Device Problem Code	Suction Problem (2170)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/23/2025
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).
Event or Problem Description
A healthcare professional reported that cutter stopped aspirating in the midway during vitrectomy surgery.A new pak was opened to complete the surgery on the same day.There was no information about patient impact.
Additional Manufacturer Narrative
Additional information provided in h.6.And h.11.No technical inquiries were received from the customer.A sample was not received at the investigation site for evaluation; therefore, the condition of the product could not be verified.A review of the device history record traceable to the reported lot number, indicates that the reported product was processed and released according to the reported product¿s acceptance criteria.The photo attached to the file was reviewed by the manufacturing site.The photo contains four photos all in one document.One photo shows a pak label, reported product and lot information is confirmed.The other three photos show different screens of the console relating to an error.The reported issue could not be confirmed.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.As the root cause and its origin are inconclusive, further investigative or manufacturing actions are not warranted at this time.All probes are 100% visually inspected and tested for actuation, aspiration, and cut during manufacturing.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).
Additional Manufacturer Narrative
No technical inquiries were received from the customer.One opened probe was received, without 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 on the welded cap.The sample was then functionally tested for actuation and aspiration.The sample was found to be nonconforming for both tests.The probe was disassembled and the components inspected.No/minimal wear observed on inner cutter when compared to the degree of wear based on continuous actuation of the probe visual standard photos.Gauge 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 actuation and aspiration with the probe driver and was able to actuate and aspirate.The initial actuation and aspiration test failed due to an interference in the aspiration path and once the interference was removed the probe was able to aspirate.The probe engine was disassembled, and the components were inspected.O-rings, spacer, and diaphragm were all intact.A review of the device history record traceable to the lot number obtained from the device¿s radio frequency identification (rfid) tag, indicates that the reported product was processed and released according to the reported product¿s acceptance criteria.The photos attached to the file were reviewed by the manufacturing site.One photo shows a pak label, reported product and lot information is confirmed.The other three photos show different screens of the console relating to an error.The reported issue could not be confirmed.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 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 COMBINED 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: 23595424
• Report Number: 1644019-2025-04875
• Device Sequence Number: 21147101
• Product Code: LRO
• UDI-Device Identifier: 00380650004840
• UDI-Public: (01)00380650004840(17)270430(11)250512(10)17E3FY
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/27/2026

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: 8065000484
• Device Lot Number: 17E3FY
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/23/2025
• Supplement Date Received by Manufacturer: 01/23/2026; 04/03/2026
• Initial Report FDA Received Date: 11/19/2025
• Supplement Report FDA Received Date: 02/18/2026; 04/27/2026
• Date Device Manufactured: 05/12/2025
• 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