Millennium
Millennium Phaco Handpice
1manufacturer
1catalogue number
28recalls on this code
Who Else Makes It
Registered in Guangdong. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| ABA Medical Technology Co Ltd | Guang Dong | Guangdong | Contract manufacturer | 6 |
Record
| Listed by | Bausch & Lomb Incorporated, United States |
|---|---|
| FDA product code | HQE |
| Device type | Instrument, Vitreous Aspiration And Cutting, Ac-Powered |
| Device class | Class 2 |
| Regulation | 21 CFR 886.4150 |
| Establishment | Remanufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2016-09-24 |
| Record revised | 2024-05-15 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| CX7000 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Bausch + Lomb | Bausch & Lomb Incorporated | 108 |
| Unity | Alcon Laboratories, Inc. | 47 |
| Synergetics | Synergetics USA, Inc. | 44 |
| Bi-Blade® | Medical Instrument Development Laboratories, Inc. | 28 |
| Instrument, Vitreous Aspiration And Cutting, Ac-Powered | Medical Instrument Development Laboratories, Inc. | 21 |
| Alcon | Alcon Laboratories, Inc. | 14 |
| Constellation | Alcon Laboratories, Inc. | 9 |
| Stellaris | Bausch & Lomb Incorporated | 6 |
| EVA Nexus™ Posterior 25G TDC Pack | D.o.r.c. Dutch Ophthalmic Research Center (International) B.V. | 4 |
| EVA Nexus™ Posterior 23G TDC Pack | D.o.r.c. Dutch Ophthalmic Research Center (International) B.V. | 4 |
| EVA Nexus™ Posterior 27G TDC Pack | D.o.r.c. Dutch Ophthalmic Research Center (International) B.V. | 4 |
| Engauge, Vektor | Alcon Laboratories, Inc. | 3 |
Showing 12 of 65. All products under Instrument, Vitreous Aspiration And Cutting, Ac-Powered
Recalls
13 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2018-08-08 | Class II | Nonconforming Material/Component | The back cap separates from the body of the vitrectomy cutter. | 9 cases | 2019-08-28 |
| 2018-08-08 | Class II | Nonconforming Material/Component | The back cap separates from the body of the vitrectomy cutter. | 103.33 cases | 2019-08-28 |
| 2018-08-08 | Class II | Nonconforming Material/Component | The back cap separates from the body of the vitrectomy cutter. | 39.33 cases | 2019-08-28 |
| 2018-08-08 | Class II | Nonconforming Material/Component | The back cap separates from the body of the vitrectomy cutter. | 94 cases | 2019-08-28 |
| 2018-08-08 | Class II | Nonconforming Material/Component | The back cap separates from the body of the vitrectomy cutter. | 10 cases | 2019-08-28 |
| 2018-08-08 | Class II | Nonconforming Material/Component | The back cap separates from the body of the vitrectomy cutter. | 16 cases | 2019-08-28 |
| 2018-08-08 | Class II | Nonconforming Material/Component | The back cap separates from the body of the vitrectomy cutter. | 97.33 cases | 2019-08-28 |
| 2018-08-08 | Class II | Nonconforming Material/Component | The back cap separates from the body of the vitrectomy cutter. | 33 cases | 2019-08-28 |
| 2018-08-08 | Class II | Nonconforming Material/Component | The back cap separates from the body of the vitrectomy cutter. | 131 cases | 2019-08-28 |
| 2018-08-08 | Class II | Nonconforming Material/Component | The back cap separates from the body of the vitrectomy cutter. | 66 cases | 2019-08-28 |
| 2018-08-08 | Class II | Nonconforming Material/Component | The back cap separates from the body of the vitrectomy cutter. | 15.33 cases | 2019-08-28 |
| 2018-08-08 | Class II | Nonconforming Material/Component | The back cap separates from the body of the vitrectomy cutter. | 19.33 cases | 2019-08-28 |
| 2018-08-08 | Class II | Nonconforming Material/Component | The back cap separates from the body of the vitrectomy cutter. | 67 cases | 2019-08-28 |
| 2010-01-08 | Not classified | Component design/selection | Users may incorrectly assemble the plastic needle wrench to the phacoemulsification needle resulting in the generation of plastic particulate | 11,039/6-pack boxes | 2012-04-02 |
| 2010-01-08 | Not classified | Component design/selection | Users may incorrectly assemble the plastic needle wrench to the phacoemulsification needle resulting in the generation of plastic particulate | 1,198/6-pack boxes | 2012-04-02 |
| 2010-01-08 | Not classified | Component design/selection | Users may incorrectly assemble the plastic needle wrench to the phacoemulsification needle resulting in the generation of plastic particulate | 2,243/6-pack boxes | 2012-04-02 |
| 2010-01-08 | Not classified | Component design/selection | Users may incorrectly assemble the plastic needle wrench to the phacoemulsification needle resulting in the generation of plastic particulate | 635/6-pack boxes | 2012-04-02 |
| 2010-01-08 | Not classified | Component design/selection | Users may incorrectly assemble the plastic needle wrench to the phacoemulsification needle resulting in the generation of plastic particulate | 74/6-pack boxes | 2012-04-02 |
| 2010-01-08 | Not classified | Component design/selection | Users may incorrectly assemble the plastic needle wrench to the phacoemulsification needle resulting in the generation of plastic particulate | 14,685/6-pack boxes | 2012-04-02 |
| 2010-01-08 | Not classified | Component design/selection | Users may incorrectly assemble the plastic needle wrench to the phacoemulsification needle resulting in the generation of plastic particulate | 18.998/6-pack boxes | 2012-04-02 |
| 2010-01-08 | Not classified | Component design/selection | Users may incorrectly assemble the plastic needle wrench to the phacoemulsification needle resulting in the generation of plastic particulate | 345/6-pack boxes | 2012-04-02 |
| 2010-01-08 | Not classified | Component design/selection | Users may incorrectly assemble the plastic needle wrench to the phacoemulsification needle resulting in the generation of plastic particulate | 9,967/6-pack boxes | 2012-04-02 |
| 2010-01-08 | Not classified | Component design/selection | Users may incorrectly assemble the plastic needle wrench to the phacoemulsification needle resulting in the generation of plastic particulate | 437/6-pack boxes | 2012-04-02 |
| 2010-01-08 | Not classified | Component design/selection | Users may incorrectly assemble the plastic needle wrench to the phacoemulsification needle resulting in the generation of plastic particulate | 272/6-pack boxes | 2012-04-02 |
| 2007-02-09 | Not classified | Other | The cutter probe tip breaks during use. | 32,190 units of Catalog No: CX 5825 | 2009-04-07 |
| 2007-02-09 | Not classified | Other | The cutter probe tip breaks during use. | 13,685 units of Catalog No: CX4925 | 2009-04-07 |
| 2006-12-14 | Not classified | Other | The cutter tip could break during a procedure | Cat. CX4920 – 4,475 packs; and Cat. CX4920A – 40 packs | 2009-04-07 |
| 2006-12-14 | Not classified | Other | The cutter tip could break during a procedure | Cat. CX4804 – 3,485 Cutter Tips | 2009-04-07 |
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.