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 Codes	Particulates (1451); Obstruction of Flow (2423); Excessive Heating (4030)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/12/2026
Type of Reportable Event	Malfunction
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).
Event or Problem Description
A customer reported that milky-white smoke, as described by the surgeon, came out of the tip of an ophthalmic handpiece during a cataract removal procedure with intraocular lens placement.The event occurred during the procedure while the system was in quadrant removal mode, and an occlusion message was displayed.The handpiece was removed and replaced with a different handpiece, and the procedure was completed on the same day.There was patient contact however, no visible patient impact was observed, and no additional medical intervention was required.

• 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: 50689251
• Report Number: 2028159-2026-01413
• Device Sequence Number: 17636171
• Product Code: HQC
• UDI-Device Identifier: 00380657529148
• UDI-Public: (01)00380657529148(17)350728(11)250730(10)17JTM9
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K161794
• 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): 09/09/2026

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: 17JTM9
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/19/2026
• Initial Report FDA Received Date: 09/09/2026
• Date Device Manufactured: 07/30/2025
• 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
• Patient Age: 67 YR
• Patient Sex: Female