MAUDE Adverse Event Report: ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER CONSTELLATION VISION SYSTEM; UNIT, PHACOFRAGMENTATION

Catalog Number	8065753041
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/01/2026
Type of Reportable Event	Malfunction

• 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 ; 8007579780
• MDR Report Key: 25838481
• Report Number: 2028159-2026-01063
• Device Sequence Number: 18581921
• Product Code: HQC
• UDI-Device Identifier: 00380657530410
• UDI-Public: (01)00380657530410(17)300124(11)200127(10)13J4Y9
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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): 07/16/2026

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: 8065753041
• Device Lot Number: 13J4Y9
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/25/2026
• Initial Report FDA Received Date: 07/16/2026
• Date Device Manufactured: 01/27/2020
• 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