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

Catalog Number	8065000297
Medical Device Problem Code	Air/Gas in Device (4062)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Event or Problem Description
A non-healthcare professional reported that bubbles during quad, cortex, and visco removal.The surgeon stated that these bubbles are affecting visibility during surgery.The procedure type was unknown.The issue persisted despite adjustments to the intraocular pressure ramp and incision size/tip sleeve settings.These changes reduced the frequency of the bubbles; however, bubbles during cortex and/or viscoelastic removal continued to occur in approximately 50 percent of cases, and bubbles during quadrant removal was observed in 5 cases.Although the issue was no longer present in every case, the surgeon continued to report impaired visualization.The surgery completion details were unknown.There was no information about the patient impact.This complaint pertains to the ophthalmic system involved in the reported events and represents three of the three reports received from the same facility.
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.

• Brand Name: UNITY CS 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: 50755655
• Report Number: 2028159-2026-01443
• Device Sequence Number: 18529471
• Product Code: HQC
• UDI-Device Identifier: 00380650002976
• UDI-Public: (01)00380650002976(17)360203(11)260205(10)17X0ND
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K233876
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/14/2026

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: 8065000297
• Device Lot Number: 17X0ND
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/18/2026
• Initial Report FDA Received Date: 09/14/2026
• Date Device Manufactured: 02/05/2026
• 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
• Patient Sex: Unknown