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	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/02/2026
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 health care professional reported that the tip of an infusion line was clogged with one pak during set up for vitrectomy surgery.The surgery was completed post replacement of console but nothing was wrong with console as it was confirmed that the infusion cannula was found to be clogged.There was no impact to the patient.
Additional Manufacturer Narrative
Additional information provided in d.9., h.3., h.6.And h.11.The wet pack was visually inspected.Flash in the straight through connector restricted fluid to flow to the infusion cannula tip.The system is designed to perform quality safety to detect for this unwarranted condition and alert the user during priming, prior to surgery.The straight through connector is a molded component by our supplier manufacturer.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.The root cause of the customer¿s complaint is related to insufficient draft on the core pin led to material adhesion and subsequent degradation of the shutoff surface, resulting in intermittent flash and/or occlusion of the molded bore.Action was taken and to address root cause the supplier has replaced damaged core pins, repaired tool damage, and completed gate area tooling repairs.Production of the part will also be run at nominal parameters for a minimum prescribed period with engineering batch review, along with engineering trials to evaluate increased draft effectiveness.Additionally, supplier will execute verification production runs under heightened inspection to confirm absence of stretched necks, flash, or bore occlusion.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: 24466911
• Report Number: 1644019-2026-01110
• Device Sequence Number: 18473056
• Product Code: LRO
• UDI-Device Identifier: 00380650004840
• UDI-Public: (01)00380650004840(17)270531(11)250605(10)17FFH5
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K880961
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/26/2026

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: 17FFH5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/05/2026
• Supplement Date Received by Manufacturer: 05/05/2026
• Initial Report FDA Received Date: 02/27/2026
• Supplement Report FDA Received Date: 05/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/05/2025
• 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