510(k) K141065 ยท HQE Instrument, Vitreous Aspiration And Cutting, Ac-Powered
CONSTELLATION VISION SYSTEM
| Applicant | Alcon Research, Ltd., Lake Forest CA, US |
| Decision | Substantially Equivalent, Aug 22, 2014 |
| Received | Apr 24, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K141065
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 24, 2025 | Alcon Research LLC Brand Name: Alcon Laboratories, Inc.
Product Name: Accessory devices for Unity and Constellation surgical consoles
Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List'
8065000250 UN Open, Classified |
MLZ | None listed |
| Oct 24, 2025 | Alcon Research LLC Brand Name: Alcon Laboratories, Inc.
Product Name: Accessory devices for Unity and Constellation surgical consoles
Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List'
8065750918 PA Open, Classified |
HQC | None listed |
| Jul 10, 2025 | Alcon Research LLC Brand Name: Alcon Laboratories, Inc.
Product Name: Constellation Vision System Vitrectomy Procedure Pak
Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List'
Software Version: N/A
Pr Open, Classified |
MLZ | None listed |
| Jul 10, 2025 | Alcon Research LLC Brand Name: Alcon Laboratories, Inc.
Product Name: Constellation Vision System Combined Procedure Pak
Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List'
Software Version: N/A
Prod Open, Classified |
HQC | None listed |
| Oct 11, 2023 | Alcon Research, LLC Constellation Vision System, REF: 8065751150 Open, Classified |
HQC | None listed |
| Aug 16, 2023 | Alcon Research, LTD. Constellation Procedure Pak Open, Classified |
HQC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.