Staar
***NON-Sterile*** Staar Plunger, 3MM PVA W/DK Blue Handle, Bulk (600/SP)
7manufacturers in China registered for this device type
1catalogue number
1recall
Who Else Makes It
Concentrated in Zhejiang (3), Guangdong (3), 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 |
|---|---|---|---|---|
| GRI Medical & Electronic Technology Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 71 |
| Huizhou Foryou Medical Devices Co., Ltd. | Huizhou | Guangdong | Contract manufacturer | 18 |
| Wenzhou Duola Trade Co., Ltd. | Wenzhou | Zhejiang | Contract manufacturer | 4 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Shenzhen JPY ION-Tech. Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 20 |
| Shenzhen Create Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 9 |
| Wenzhou Easy & Lucky Optical Trade Co., Ltd. | Wenzhou | Zhejiang | Contract manufacturer | 4 |
Record
| Listed by | Beaver-Visitec International, Ltd, United Kingdom |
|---|---|
| FDA product code | HOZ |
| Device type | Sponge, Ophthalmic |
| Device class | Class 2 |
| Regulation | 21 CFR 886.4790 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2024-06-27 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Storage | Special storage condition: Store in a dry place. |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| STAAR35030150 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Eyetec | Network Medical Products, Ltd. | 71 |
| Ultracell | Beaver-Visitec International, Ltd | 44 |
| Merocel | Beaver-Visitec International, Ltd | 27 |
| Sugi | Questalpha GmbH & Co. KG | 22 |
| MSI Precision Specialty Instruments | MED Saver, Inc. | 18 |
| Netcell | Network Medical Products, Ltd. | 18 |
| DeRoyal | Deroyal Industries, Inc. | 17 |
| Eyetec | Summit Medical LLC | 17 |
| PRO-Paks®️ | Microspecialities, Inc. | 16 |
| Kitpack | Network Medical Products, Ltd. | 16 |
| Atlanta Healthcare Services OcuDrape® | Atlanta Healthcare Services | 14 |
| Coronet | Network Medical Products, Ltd. | 14 |
Showing 12 of 64. All products under Sponge, Ophthalmic
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 |
|---|---|---|---|---|
| 2022-12-20 | Class II | Process control | Device packaging may contain open seals, compromising product sterility. | 4640 units in total |
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.