Zero Phaco HDP 30DEG 12/b
Catalogue number SUP03, listed by Bausch & Lomb Incorporated, United States, under Unit, Phacofragmentation. 4 manufacturers in China are registered for this product code.
4manufacturers in China registered for this device type
1catalogue number
11510(k) clearances naming this product code
18recalls on this 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 | Bausch & Lomb Incorporated, United States |
|---|---|
| FDA product code | HQC |
| Device type | Unit, Phacofragmentation |
| Device class | Class 2 |
| Regulation | 21 CFR 886.4670 |
| Establishment | Remanufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2016-07-15 |
| Record revised | 2024-07-17 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| SUP03 | 12 | In distribution |
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 |
| Constellation | Alcon Laboratories, Inc. | 16 |
| 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 |
Showing 12 of 619. All products under Unit, Phacofragmentation
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K170052 | 2017-04-19 |
| K162342 | 2017-03-24 |
| K133486 | 2014-03-12 |
| K133242 | 2014-02-14 |
| K101325 | 2010-08-17 |
| K082473 | 2009-01-05 |
| K082132 | 2008-08-28 |
| K073023 | 2008-03-12 |
| K063331 | 2006-12-19 |
| K041998 | 2004-08-16 |
| K033653 | 2003-12-17 |
Recalls
1 of these is 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 |
|---|---|---|---|---|---|
| 2012-08-31 | Class II | Process control | Posterior fluidics modules installed in the system may need to be recalibrated. | 124 units | 2013-07-11 |
| 2011-07-27 | Not classified | Nonconforming Material/Component | The aspiration channel on the affected vacuum cassettes may be blocked due to a molding malfunction | 229/6-unit cases | 2013-06-21 |
| 2011-07-27 | Not classified | Nonconforming Material/Component | The aspiration channel on the affected vacuum cassettes may be blocked due to a molding malfunction | 6/6-unit cases | 2013-06-21 |
| 2011-07-27 | Not classified | Nonconforming Material/Component | The aspiration channel on the affected vacuum cassettes may be blocked due to a molding malfunction | 9/6-unit cases | 2013-06-21 |
| 2011-07-27 | Not classified | Nonconforming Material/Component | The aspiration channel on the affected vacuum cassettes may be blocked due to a molding malfunction | 2/6-unit cases | 2013-06-21 |
| 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 | 280/6-pouch 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 | 7,256/12-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 | 8,964/6-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 | 308/6-pouch 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 | 1,958/6-pouch 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 | 6,111/6-pouch 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 | 286/6-pouch 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 | 233/6-pouch 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 | 783/6-pouch 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 | 2,282/6-pouch 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 | 1,265/6-pack boxes | 2012-04-02 |
| 2003-08-25 | Not classified | Other | The firm’s DP8200 Microflow Needle Packs were labeled with the firm’s DP8115 Phaco Needle Packs and visa versa. | 44 boxes | 2003-12-15 |
| 2003-08-25 | Not classified | Other | The firm’s DP8200 Microflow Needle Packs were labeled with the firm’s DP8115 Phaco Needle Packs and visa versa. | 22 boxes | 2003-12-15 |
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.