MAUDE Adverse Event Report: Alcon Research, LLC - Irvine Technology Center CENTURION Vision System, Accessory, Active Sentry Handpiece; Unit, phacofragmentation

Catalog Number	8065752914
Medical Device Problem Code	No Device Output (1435)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/01/2026
Type of Reportable Event	Malfunction

• Brand Name: CENTURION Vision System, Accessory, Active Sentry Handpiece
• 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: 50924040
• Report Number: 2028159-2026-01529
• Device Sequence Number: 12206719
• Product Code: HQC
• UDI-Device Identifier: 00380657529148
• UDI-Public: (01)00380657529148(17)330821(11)230824(10)1644WA
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K161794
• 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
• Report Date (Section B): 09/28/2026

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: 8065752914
• Device Lot Number: 1644WA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 09/04/2026
• Initial Report FDA Received Date: 09/28/2026
• Date Device Manufactured: 08/24/2023
• 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