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

Catalog Number	8065753057
Medical Device Problem Code	Suction Problem (2170)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/06/2026
Type of Reportable Event	Malfunction

• Brand Name: CENTURION Vision System (Active Sentry)
• 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: 50099637
• Report Number: 2028159-2026-01210
• Device Sequence Number: 9913481
• Product Code: HQC
• UDI-Device Identifier: 00380657530571
• UDI-Public: (01)00380657530571(17)330919(11)230922(10)167FVC
• Combination Product (Y/N): N
• Initial Reporter Country: MU
• PMA/510(K) Number: K161794
• 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): 07/31/2026

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: 8065753057
• Device Lot Number: 167FVC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 07/09/2026
• Initial Report FDA Received Date: 07/31/2026
• Date Device Manufactured: 09/22/2023
• 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