MAUDE Adverse Event Report: Alcon Research, LLC - Irvine Technology Center CONSTELLATION Vision System; Unit, phacofragmentation

Model Number	TABLETOP
Medical Device Problem Codes	Failure to Power Up (1476); Failure to Cut (2587); Computer Operating System Problem (2898); Suction Failure (4039)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/02/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A physician reported that, during a vitrectomy surgery, an ophthalmic console took significantly longer than expected to start up, and there was an unexpected change in the saved surgical settings.In addition, while using the foot pedal for vitrectomy, the cutter rate progressively decreased without user intervention, and the aspiration level gradually diminished until no aspiration was present.The procedure was completed on the same day.No adverse patient outcome was reported.Additional information has been requested; however, none has been received to date.
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).

• Brand Name: CONSTELLATION Vision System
• 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: 50426303
• Report Number: 2028159-2026-01329
• Device Sequence Number: 13055918
• Product Code: HQC
• UDI-Device Identifier: 00380657511501
• UDI-Public: (01)00380657511501(17)271019(11)171019(10)11X25F
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K101285
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/25/2026

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 Model Number: TABLETOP
• Device Catalogue Number: 8065751150
• Device Lot Number: 11X25F
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 08/04/2026
• Initial Report FDA Received Date: 08/25/2026
• Date Device Manufactured: 10/19/2017
• 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