Vortex Surgical Inc.
Lindsell Sutured IOL Marker
3manufacturers in China registered for this device type
1catalogue number
1recall
Who Else Makes It
Concentrated in Jiangsu (2), Hubei (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 |
| Hubei Lanbin Medical Group Co., Ltd. | Xiaogan | Hubei | Contract manufacturer | 33 |
| Sihong Ophsurin Co., Ltd. | Suqian | Jiangsu | Manufacturer | 17 |
Record
| Listed by | Vortex Surgical, Inc., United States |
|---|---|
| FDA product code | HMQ |
| Device type | Marker, Sclera |
| Device class | Class 1 |
| Regulation | 21 CFR 886.4570 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2025-04-18 |
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 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| VS0390 | 5 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Stephens Instruments | Krishna Imports Inc | 61 |
| MSI Precision Specialty Instruments | MED Saver, Inc. | 31 |
| Malosa Medical | Beaver-Visitec International, Ltd | 2 |
| Braunstein Marker | Blink Medical Ltd | 1 |
| Marker Double Ended 3.5mm-4mm | Blink Medical Ltd | 1 |
| Thornton TWO RAY Meridian Marker | Sontec Instruments, Inc. | 1 |
| Bausch + Lomb | Bausch & Lomb Incorporated | 1 |
| Dual Tip Marker Pen – Methylene Blue | Hurricane Medical | 1 |
| Thornton Corneal Marker | Sontec Instruments, Inc. | 1 |
| Scleral Marker | Katena Products, Inc. | 1 |
| Marker Pad – Methylene Blue | Hurricane Medical | 1 |
| Dual Tip Marker Pen – Gentian Violet | Hurricane Medical | 1 |
Showing 12 of 16. All products under Marker, Sclera
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 |
|---|---|---|---|---|
| 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) |
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.