Constellation
Constellation Vision System Irrigation/Aspiration Tubing Set
4manufacturers in China registered for this device type
16catalogue numbers in this listing
8510(k) clearances naming this product code
Who Else Makes It
Concentrated in Guangdong (2), Shanghai (1), Jiangsu (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Sanmina | Kunshan | Jiangsu | Contract manufacturer | 15 |
| Providence Enterprise Limited | Shenzhen | Guangdong | Contract manufacturer | 9 |
| ABA Medical Technology Co Ltd | Guang Dong | Guangdong | Contract manufacturer | 6 |
| Sterigenics Shanghai ETO Ltd. | Shanghai | Shanghai | Contract manufacturer | 65 |
Record
| Listed by | Alcon Laboratories, Inc., United States |
|---|---|
| FDA product code | HQC |
| Device type | Unit, Phacofragmentation |
| Device class | Class 2 |
| Regulation | 21 CFR 886.4670 |
| Record published | 2016-09-24 |
| Record revised | 2024-03-22 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Packaging | Box of 6, box of 12, pack of 12 |
| Distribution end date | 2021-12-31 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 8065750968 | In distribution | |
| 8065750920 | In distribution | |
| 8065751162 | In distribution | |
| 8065751541 | In distribution | |
| 8065750958 | 20 Gauge | In distribution |
| 8065751885 | In distribution | |
| 8065751163 | In distribution | |
| 8065750888 | In distribution | |
| 8065751540 | In distribution | |
| 8065750918 | In distribution | |
| 8065750917 | In distribution | |
| 8065750914 | In distribution | |
| 8065750957 | In distribution | |
| 8065751155 | In distribution | |
| 8065752537 | Withdrawn | |
| 8065751158 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Bausch + Lomb | Bausch & Lomb Incorporated | 109 |
| Alcon | Alcon Laboratories, Inc. | 95 |
| Oertli® | Oertli Instrumente AG | 66 |
| Laminar | Johnson & Johnson Surgical Vision, Inc. | 40 |
| Engauge | Alcon Laboratories, Inc. | 18 |
| Unity | Alcon Laboratories, Inc. | 18 |
| MST/Packard A1.7mm Phaco Tip Bent Dewey 30° | Microsurgical Technology, Inc. | 11 |
| Whitestar Signature | Johnson & Johnson Surgical Vision, Inc. | 10 |
| Alcon, Infiniti, MicroSmooth, ABS | Alcon Laboratories, Inc. | 10 |
| Compact Intuitiv | Johnson & Johnson Surgical Vision, Inc. | 9 |
| Alcon, Infiniti, Intrepid | Alcon Laboratories, Inc. | 9 |
| MST.7mm A1 Bent Phaco Tip 45° | Microsurgical Technology, Inc. | 8 |
Showing 12 of 619. All products under Unit, Phacofragmentation
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K233876 | 2024-06-21 |
| K233902 | 2024-01-10 |
| K121555 | 2012-12-21 |
| K021566 | 2002-07-02 |
| K981103 | 1998-06-23 |
| K955789 | 1996-03-21 |
| K952213 | 1995-08-09 |
| K911808 | 1991-06-25 |
Recalls Naming This Product
1 recall names this product by its own identifier, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Alcon Research, LLC | UDI-DI | 2025-08-05 | Class II | Process control | Due to incomplete seals in the pouch which provide the sterile barrier. | 25,778 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.