ACTU8 Adaptive Forceps
Ophthalmic Forceps
12manufacturers in China registered for this device type
2catalogue numbers in this listing
2recalls on this code
Who Else Makes It
Concentrated in Jiangsu (9), Shanghai (1), Shandong (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Malosa Medical Instruments (Changshu) Limited | Changshu | Jiangsu | Contract manufacturer | 24 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Hubei Lanbin Medical Group Co., Ltd. | Xiaogan | Hubei | Contract manufacturer | 33 |
| 66 Vision Tech Co., Ltd. | Suzhou | Jiangsu | Private-label distributor | 24 |
| Asol Co., Ltd. | Huaian | Jiangsu | Manufacturer | 22 |
| Huaian Tisurg Medical Instruments Co., Ltd. | Huaian | Jiangsu | Contract manufacturer | 22 |
| Belle Healthcare Technology Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 20 |
| Sihong Ophsurin Co., Ltd. | Suqian | Jiangsu | Manufacturer | 17 |
| Huaian Frimen Co., Ltd. | Huaian | Jiangsu | Manufacturer | 16 |
| Huaian Wolfram Surgical Instruments | Huaian | Jiangsu | Manufacturer | 14 |
| Visuscience Meditech Co., Ltd. | Wuxi | Jiangsu | Specification developer | 9 |
Record
| Listed by | Vortex Surgical, Inc., United States |
|---|---|
| FDA product code | HNR |
| Device type | Forceps, Ophthalmic |
| Device class | Class 1 |
| Regulation | 21 CFR 886.4350 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-03-15 |
| Record revised | 2022-11-21 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 23ga | In distribution | |
| 25ga | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Ambler Surgical | Ambler Surgical, LLC | 812 |
| MSI Precision Specialty Instruments | MED Saver, Inc. | 542 |
| Walcott Rx Products | Walcott Rx Product Inc | 365 |
| Sklar | Sklar Corporation | 346 |
| Millennium | Avalign Technologies, Inc. | 329 |
| MR Phaco | Crestpoint Management Ltd. | 322 |
| Bausch + Lomb | Bausch & Lomb Incorporated | 313 |
| Epsilon USA | Epsilon EYE Care PVT., Ltd. | 283 |
| Stephens Instruments | Krishna Imports Inc | 275 |
| Wexler Surgical, Inc. | Wexler Surgical, Inc. | 256 |
| Rumex | Rumex International Co. | 248 |
| Assi | Accurate Surgical & Scientific Instruments Corp. | 195 |
Showing 12 of 1,959. All products under Forceps, Ophthalmic
Recalls
2 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 |
|---|---|---|---|---|---|
| 2025-12-16 | Class II | Employee error | There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination which could lead to infection. | 14,789 (8651 US; 6138 OUS) | |
| 2023-12-18 | Class II | Device Design | Reason for the voluntary recall is residue was identified on the two forceps tips of a customer in Korea. The residue is associated with one lot of forceps tips which were utilized in two lots of ACTU8 Adaptive Forceps Tips occurring in 0.2 | 800 devices | 2024-04-04 |
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.