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

Catalog Number	8065000296
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Capsular Bag Tear (2639)
Date of Event	08/11/2026
Type of Reportable Event	Serious Injury

• 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: 50630012
• Report Number: 2028159-2026-01401
• Device Sequence Number: 16126638
• Product Code: HQC
• UDI-Device Identifier: 00380650002969
• UDI-Public: (01)00380650002969(17)351106(11)251108(10)17PWY3
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/01/2026

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 8065000296
• Device Lot Number: 17PWY3
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 09/09/2026
• Initial Report FDA Received Date: 09/05/2026
• Supplement Report FDA Received Date: 10/01/2026
• Date Device Manufactured: 11/08/2025
• 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