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	Suction Problem (2170); Free or Unrestricted Flow (2945); Improper Flow or Infusion (2954)
Health Effect - Clinical Codes	Blurred Vision (2137); Intraocular Pressure Decreased (4468)
Date of Event	09/18/2025
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
The physician reported that an ophthalmic operating system was used for the vitro retinal surgery.During the surgery the system pressure was too high, and physician attempted to switch to air mode, but system did not deliver the air and patient had poor vision, severe hypotony and patient received decaline injection to flatten the retina.The surgeon attempted to inject silicone, but instead of using the trocar as recommended.The surgery was completed on the same day with another system.The current condition of the patient condition was unknown.Additional information has been requested and none received till date.
Additional Manufacturer Narrative
Additional information provided in d.9., h.2., h.3., h.6.And h.11.Two turbid packs were visually inspected.Only one probe manifold, and one infusion cannula line connecting to the yellow stopcock was observed with the returned product.The returned probe manifold and the infusion cannula line were used to test both products.The drain bags detached due to saturation.The irrigation and aspiration luers were intact.Flare shape was observed in the blue socket fittings at the aspiration tubing insertion end.The infusion airline leak test was performed by generating pressure and met specifications.No leakage was observed from the auto stopcock filters.The o-rings presented on the low-pressure air system (lpas) connectors.The products were tested using the unity console, and current software version.The products could prime and pass calibration successfully.No message code appeared on the screen.The irrigation pressure sensor (ips) / redundant pressure sensor (rps) / aspiration pressure sensor (aps) accuracy, infusion and auxiliary aspiration flow rate tests, and max vacuum level from the prime test results data all passed performance specifications.After priming, fluid air-exchange function at the prescribed setting 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 air control was on, only air was introduced from the console to the infusion cannula line, and no fluid was aspirated from the probe aspiration line and the auxiliary line.The product met specification.We were unable to replicate the customer's experience during laboratory evaluation.The investigation conducted a non-conformance review of the reported lot number.No deviation was identified that would have contributed to this event and all corresponding production release specifications defined in the device master record were met.Review of the event report provides details the system was misused at one point.Based on the evaluation of the information and materials received, the root cause of the customer's complaint could not be established; the returned product functioned per specifications.Based on the evaluation of the information and materials received, the product met specifications and therefore no corrective action is required.Before release from manufacturing, every pak batch must pass quality testing and inspection confirming that the batch meets all product and packaging specifications.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).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: 23298053
• Report Number: 1644019-2025-04015
• Device Sequence Number: 4890186
• Product Code: LRO
• UDI-Device Identifier: 00380650004789
• UDI-Public: (01)00380650004789(17)270331(11)250424(10)17CP2D
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K880961
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/21/2026

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: 17CP2D
• 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: 09/18/2025
• Supplement Date Received by Manufacturer: 12/24/2025
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 01/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/24/2025
• 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: BSS STERILE IRRIGATING SOLUTION.; UNITY VCS CONSOLE.
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Male