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

Catalog Number	8065000478
Medical Device Problem Codes	Fluid/Blood Leak (1250); Improper Flow or Infusion (2954)
Health Effect - Clinical Codes	Eye Injury (1845); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	08/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A customer reported a leaky valved cannula and a lack of air entering the eye, which resulted in the patient's eye starting to collapse with choroidal during vitrectomy surgery.The procedure was completed after replacing the replace all the infusion tubing up to the cassette, and then back into the eye under air and air began to flow normally at that time.There was no patient impact.
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.
Additional Manufacturer Narrative
Corrected additional information updated in b 2.B.5.H.6.And h.11.Correction h.6 supplemental medical device report (smdr1) is being filed to correct the h.6, codes a050401, e0819, g04133 to a1405, e2402, and g04084.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
This report represents the surgical procedure pack (25g) contributed to the lack of air to eye.
Additional Manufacturer Narrative
Additional information provided in d.9., h.3., h.6.And h.11.Only the used infusion cannula line, infusion manifold connecting to the yellow stopcock were returned and visually inspected.No obvious defect was observed.The product was tested with the lab stock posterior fluidics management system pak using the console with the current software.The product passed priming, and no system message code appeared on the console screen.Fluid air exchange function at the setting of 30 millimeters of mercury was performed on the infusion manifold for 5 times.With the infusion control on, fluid flowed from the cassette continuously without generating air to the infusion line.When the fluid/air exchange (f/ax) control was on, only air was introduced from the cassette to the infusion line.The infusion flow rate was successfully achieved.No leakage occurred from the returned components during testing.The product passed functionality per procedure.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.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 product functioned per 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 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 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: 23082167
• Report Number: 1644019-2025-03476
• Device Sequence Number: 12003449
• Product Code: LRO
• UDI-Device Identifier: 00380650004789
• UDI-Public: (01)00380650004789(17)270331(11)250425(10)17CP2K
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K880961
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/01/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 8065000478
• Device Lot Number: 17CP2K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/20/2025
• Supplement Date Received by Manufacturer: 09/29/2025; 12/08/2025
• Initial Report FDA Received Date: 09/18/2025
• Supplement Report FDA Received Date: 10/24/2025; 01/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/25/2025
• 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 CATARACT PROCEDURE PACK; UNITY TOTAL PLUS POSTERIOR PROCEDURE PACK; UNITY TOTAL PLUS POSTERIOR PROCEDURE PACK
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown