MAUDE Adverse Event Report: Alcon Research, LLC - Irvine Technology Center UNITY VCS Console; Unit, phacofragmentation

Catalog Number	8065000296
Medical Device Problem Codes	Improper Flow or Infusion (2954); Pressure Problem (3012); Unexpected Shutdown (4019); Suction Failure (4039); Priming Problem (4040)
Health Effect - Clinical Code	Intraocular Pressure Decreased (4468)
Type of Reportable Event	Serious Injury
Event or Problem Description
A customer reported that during a vitrectomy procedure with silicone oil removal and endolaser treatment, the ophthalmic system exhibited a system message and shut down on two occasions while transitioning to the laser procedural step.Following each shutdown, infusion was lost, the patient experienced decreased intraocular pressure, and the surgeon observed softening of the patient's eye.The procedure was interrupted while the system was rebooted and reprimed.After the first event, replacement of the infusion tubing and vitrectomy probe was required to successfully complete priming.During the second event, the surgeon reported a more rapid loss of intraocular pressure, consistent with active aspiration of air or air backflow through the air infusion line.The current status of the patient was unknown.Additional information received that during the system message, the residual pressure loss was observed for ten to twenty seconds.The representative advised the physician to reboot the system.The surgeon manually assessed the eye before reboot and noted pressure loss, then performed manual air injection to maintain stability of the patient's eye.The fluidics management system (fms) was later found to be ejected.The representative suspected system message may have contributed to this, but this was not confirmed.The fluidics management system (fms) was reengaged before the system was brought back up and reprimed.The ophthalmic system exhibited system message again, during the second event the surgeon reported pressure loss was more rapid the second time.
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).

• Brand Name: UNITY VCS Console
• Common Device Name: Unit, phacofragmentation
• Manufacturer (Section D): Alcon Research, LLC - Irvine Technology Center; 15800 alton parkway; irvine CA 92618
• Manufacturer (Section G): Alcon Research, LLC - Irvine Technology Center; 15800 alton parkway; irvine CA 92618
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; +1(800)757-9780
• MDR Report Key: 50176479
• Report Number: 2028159-2026-01253
• Device Sequence Number: 18210493
• Product Code: HQC
• UDI-Device Identifier: 00380650002969
• UDI-Public: (01)00380650002969(17)351105(11)251107(10)17PWXK
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K233876
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/07/2026

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: 8065000296
• Device Lot Number: 17PWXK
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 07/16/2026
• Initial Report FDA Received Date: 08/07/2026
• Date Device Manufactured: 11/07/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Unknown