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

Catalog Number	8065753041
Medical Device Problem Code	Unexpected Shutdown (4019)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information was provided in sections d9, h3, h.6 and h.11.A non-conformance-based review of the serial number was performed and did not reveal any potential contributing factors to the reported complaint.A manufacturing batch record (mbr) review was performed prior to product release to ensure that the product was manufactured in compliance with the medical device file.Based on the assessment, the product met release criteria.A review for complaints reported against this serial number was performed.No similar complaints were reported for the product lot/batch/serial under investigation.Service history was reviewed for the system.A service record relevant to the reported complaint was found.Service record (sr) was opened to address the reported event.A company representative performed an on-site assessment and was unable to confirm or replicate the reported event.The representative noticed that the power cord pins was loose.As a preventative measure, the representative replaced the molded power cord, then found the system to perform as intended.A company representative performed an on-site assessment and was unable to confirm or replicate the reported event.The representative noticed that the power cord pins were loose.As a preventative measure, the representative replaced the molded power cord, then found the system to perform as intended.The system was found to have no problem; therefore, the root cause of the reported event is inconclusive.Through investigation of this complaint, it has been determined that the product had no problem.Therefore, no corrective actions will be pursued at this time.Quality assurance has reviewed this complaint and will continue to monitor data for evidence of adverse trending and take further action, as appropriate.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: 50158482
• Report Number: 2028159-2026-01237
• Device Sequence Number: 10708704
• Product Code: HQC
• UDI-Device Identifier: 00380657530410
• UDI-Public: (01)00380657530410(17)340915(11)240917(10)172A7A
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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,Followup
• Report Date (Section B): 09/23/2026

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: 172A7A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 07/16/2026
• Supplement Date Received by Manufacturer: 08/31/2026
• Initial Report FDA Received Date: 08/06/2026
• Supplement Report FDA Received Date: 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/17/2024
• 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