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

Catalog Number	8065000296
Medical Device Problem Codes	Restricted Flow rate (1248); Air/Gas in Device (4062)
Health Effect - Clinical Codes	Capsular Bag Tear (2639); Zonular Dehiscence (2698)
Date of Event	08/31/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
A physician reported that during cataract surgery while using an ophthalmic system the phacoemulsification phase was completed without incident.During the cortex removal phase, reflux was unavailable despite the physician activating the foot pedal to the left approximately six to seven times.The physician continued attempting to activate reflux, after which a small surge of bubbles occurred in the eye and obstructed the surgical view.Subsequently, patient experienced zonular weakness and posterior capsular tear necessitating an anterior vitrectomy.As the patient had a history of glaucoma, and the patient was left aphakic.The patient underwent second surgery, and a sutured intraocular lens (iol) was inserted on a different day.Current patient condition was unknown.Additional information has been requested but is not available at the time of this report.
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 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: 50885271
• Report Number: 2028159-2026-01514
• Device Sequence Number: 10667645
• Product Code: HQC
• UDI-Device Identifier: 00380650002969
• UDI-Public: (01)00380650002969(17)350727(11)250729(10)17JY3R
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K233876
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/24/2026

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: 17JY3R
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 09/01/2026
• Initial Report FDA Received Date: 09/24/2026
• Date Device Manufactured: 07/29/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: UNITY Cataract FMS Procedure Pack
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 82 YR
• Patient Sex: Unknown