Whitestar Signature
Remote, Whitestar Signature, Refurbished
4manufacturers in China registered for this device type
10catalogue numbers in this listing
2510(k) clearances naming this product code
7recalls 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 | Johnson & Johnson Surgical Vision, Inc., United States |
|---|---|
| FDA product code | HQC |
| Device type | Unit, Phacofragmentation |
| Device class | Class 2 |
| Regulation | 21 CFR 886.4670 |
| Establishment | Specification developer, Manufacturer |
| Record published | 2016-09-02 |
| Record revised | 2024-06-25 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Storage | Storage environment temperature -20 to 60 °C; Handling environment temperature -20 to 60 °C; Storage environment humidity 95 to 95 % RH; Handling environment humidity 95 to 95 % RH |
| Packaging | Box of 6 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| NGP680300 | In distribution | |
| NGP680702 | In distribution | |
| NGP680136R | In distribution | |
| OPO73 | In distribution | |
| NGP680135R | In distribution | |
| NGP680701 | In distribution | |
| NGP680701R | In distribution | |
| NGP680136 | In distribution | |
| NGP680702R | In distribution | |
| OPO70 | 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 |
| 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 |
|---|---|
| K203060 | 2021-03-12 |
| K191933 | 2019-08-16 |
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 |
|---|---|---|---|---|---|---|
| Johnson & Johnson Surgical Vision, Inc. | UDI-DI | 2022-12-07 | Class II | Process control | Weld protrusion/physical gap between the housing and phaco pack cover, may exceed design specification, which could lead to priming cycle failure and/or suboptimal vacuum delivered to the phacoemulsification and irrigation/aspiration handpi | 7644 |
Recalls
6 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 |
|---|---|---|---|---|
| 2024-03-14 | Class II | Process control | Due to a manufacturing variation of the irrigation sleeves which could result in a missing port hole, this non-conformity could lead to insufficient flow to cool the ultrasonic phaco tip, potentially leading to an unstable anterior chamber | 3,428 units |
| 2023-05-30 | Class II | Process control | Weld protrusion/physical gap between the housing and pack cover, may exceed design specification, due to a manufacturing issue, which could lead to priming cycle failure and/or suboptimal vacuum delivered to the phacoemulsification and irri | 148,941 |
| 2022-12-07 | Class II | Process control | Weld protrusion/physical gap between the housing and phaco pack cover, may exceed design specification, which could lead to priming cycle failure and/or suboptimal vacuum delivered to the phacoemulsification and irrigation/aspiration handpi | 384 |
| 2022-12-07 | Class II | Process control | Weld protrusion/physical gap between the housing and phaco pack cover, may exceed design specification, which could lead to priming cycle failure and/or suboptimal vacuum delivered to the phacoemulsification and irrigation/aspiration handpi | 3133 |
| 2022-09-01 | Class II | Under Investigation by firm | As a result of returned product complaints for Veritas Phaco packs related to broken or cracked irrigation luer due to a manufacturing issue. | 53,624 units |
| 2022-04-06 | Class II | Under Investigation by firm | Potential breach in the sterility barrier for tray ring covers. |
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.