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

Model Number	TABLETOP
Medical Device Problem Code	Pressure Problem (3012)
Health Effect - Clinical Code	Intraocular Pressure Decreased (4468)
Type of Reportable Event	Malfunction
Event or Problem Description
A customer reported that an ophthalmic console exhibited an unstable intraocular pressure and patient experienced hypotony during the aspiration phase of vitrectomy surgery.The current outcome of the patient condition was unknown.Additional information has been received and none received at the time of this report.
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: 50219193
• Report Number: 2028159-2026-01274
• Device Sequence Number: 21478767
• Product Code: HQC
• UDI-Device Identifier: 00380657511501
• UDI-Public: (01)00380657511501(17)281125(11)181126(10)NA
• Combination Product (Y/N): N
• Initial Reporter Country: RS
• PMA/510(K) Number: K101285
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/12/2026

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 07/17/2026
• Initial Report FDA Received Date: 08/12/2026
• Date Device Manufactured: 11/26/2018
• 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