Visitec®
Cortical Cleaving Hydrodissector [Grabow] .30 x 16mm (30G x 5/8in) (40 Degrees)
6manufacturers in China registered for this device type
124catalogue numbers in this listing
10recalls on this code
Who Else Makes It
Concentrated in Jiangsu (4), 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 |
| Asol Co., Ltd. | Huaian | Jiangsu | Manufacturer | 22 |
| Belle Healthcare Technology Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 20 |
| Huaian Frimen Co., Ltd. | Huaian | Jiangsu | Manufacturer | 16 |
Record
| Listed by | Beaver-Visitec International, Ltd, United Kingdom |
|---|---|
| FDA product code | HMX |
| Device type | Cannula, 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 | 2021-11-01 |
| Record revised | 2021-11-12 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Radiation Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Special storage condition: Store in a dry place. |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 585021 | 5 | In distribution | |
| 585292 | 1,000 | In distribution | |
| 585110 | 3 | In distribution | |
| 585046 | 10 | In distribution | |
| 585104 | 3 | In distribution | |
| 585291 | 1,000 | In distribution | |
| 585186 | 5 | In distribution | |
| 585223 | 10 | In distribution | |
| 585782 | 100 | In distribution | |
| 585226 | 10 | In distribution | |
| 585198 | 10 | In distribution | |
| 585754 | In distribution | ||
| 585143 | 10 | In distribution | |
| 581645 | In distribution | ||
| 585035 | 5 | In distribution | |
| 585742 | 100 | In distribution | |
| 585217 | 10 | In distribution | |
| 585229 | 10 | In distribution | |
| 585250 | 10 | In distribution | |
| 585205 | 10 | In distribution | |
| 581605 | In distribution | ||
| 585294 | 10 | In distribution | |
| 585159 | 10 | In distribution | |
| 585783 | 100 | In distribution | |
| 585252 | 10 | In distribution | |
| 585224 | 10 | In distribution | |
| 585745 | 10,000 | In distribution | |
| 585075 | 10 | In distribution | |
| 585199 | 10 | In distribution | |
| 585029 | 10 | In distribution | |
| 585863 | In distribution | ||
| 585107 | 10 | In distribution | |
| 585032 | 5 | In distribution | |
| 585282 | 1,000 | In distribution | |
| 585184 | 5 | In distribution | |
| 585114 | 10 | In distribution | |
| 585238 | 1,000 | In distribution | |
| 585045BS | 1,000 | In distribution | |
| 585733 | In distribution | ||
| 585003 | 10 | In distribution | |
| 585227 | 10 | In distribution | |
| 585018 | 10 | In distribution | |
| 581277 | In distribution | ||
| 585295 | 10 | In distribution | |
| 585200 | 10 | In distribution | |
| 585212 | 10 | In distribution | |
| 585216 | 5 | In distribution | |
| 585041 | 10 | In distribution | |
| 585148 | 10 | In distribution | |
| 585017 | 10 | In distribution | |
| 585219 | 5 | In distribution | |
| 585007 | 10 | In distribution | |
| 585099 | 10 | In distribution | |
| 581619 | In distribution | ||
| 585006 | 10 | In distribution | |
| 581604 | In distribution | ||
| 581615 | In distribution | ||
| 585068 | 10 | In distribution | |
| 585196 | 3 | In distribution | |
| 585789 | 100 | In distribution | |
| 585149 | 5 | In distribution | |
| 585197 | 10 | In distribution | |
| 585009 | 10 | In distribution | |
| 585119 | 5 | In distribution | |
| 585037 | 10 | In distribution | |
| 585283 | 10 | In distribution | |
| 585086 | 3 | In distribution | |
| 585047 | 5 | In distribution | |
| 585176 | 10 | In distribution | |
| 581276 | In distribution | ||
| 585191 | 10 | In distribution | |
| 585026 | 10 | In distribution | |
| 585274 | 10 | In distribution | |
| 585015 | 10 | In distribution | |
| 585757 | In distribution | ||
| 585804 | In distribution | ||
| 585005 | 10 | In distribution | |
| 585278 | 10 | In distribution | |
| 585195 | 10 | In distribution | |
| 585061 | 3 | In distribution | |
| 585147 | 10 | In distribution | |
| 585091 | 10 | In distribution | |
| 585092 | 5 | In distribution | |
| 585155 | 10 | In distribution | |
| 585743 | 100 | In distribution | |
| 581592 | In distribution | ||
| 585139 | 5 | In distribution | |
| 585173 | 5 | In distribution | |
| 585016 | 5 | In distribution | |
| 585193 | 10 | In distribution | |
| 587002 | 10 | In distribution | |
| 581624 | In distribution | ||
| 585764 | 100 | In distribution | |
| 585192 | 3 | In distribution | |
| 585040 | 10 | In distribution | |
| 585802 | In distribution | ||
| 585281 | 1,000 | In distribution | |
| 585259 | 10 | In distribution | |
| 585288 | 1,000 | In distribution | |
| 585288BNS | In distribution | ||
| 581639 | In distribution | ||
| 585158 | 10 | In distribution | |
| 585036 | 10 | In distribution | |
| 585228 | 5 | In distribution | |
| 585282BNS | 1,000 | In distribution | |
| 585163 | 10 | In distribution | |
| 587003 | 10 | In distribution | |
| 585106 | 10 | In distribution | |
| 585803 | In distribution | ||
| 585157 | 10 | In distribution | |
| 581595 | In distribution | ||
| 585777 | 100 | In distribution | |
| 581614 | In distribution | ||
| 585287 | 10 | In distribution | |
| 585025 | 10 | In distribution | |
| 585033 | 5 | In distribution | |
| 585090 | 10 | In distribution | |
| 585271 | 10 | In distribution | |
| 585222 | 10 | In distribution | |
| 585027 | 10 | In distribution | |
| 585280 | 10 | In distribution | |
| 585123 | 10 | In distribution | |
| 585774 | 100 | In distribution | |
| 585078 | 10 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Anodyne Surgical | Psi/Eye-Ko, Inc. | 909 |
| Walcott Rx Products | Walcott Rx Product Inc | 663 |
| MR Phaco | Crestpoint Management Ltd. | 625 |
| MSI Precision Specialty Instruments | MED Saver, Inc. | 511 |
| Ambler Surgical | Ambler Surgical, LLC | 447 |
| Millennium | Avalign Technologies, Inc. | 270 |
| Ophthalmic Cannula | Katena Products, Inc. | 251 |
| Surgistar | Surgistar, Inc. | 179 |
| Bausch + Lomb | Bausch & Lomb Incorporated | 137 |
| Walcott Rx Products | Psi/Eye-Ko, Inc. | 133 |
| Surgical Direct | Surgical Direct, Inc. | 127 |
| Stephens Instruments | Krishna Imports Inc | 108 |
Showing 12 of 1,064. All products under Cannula, Ophthalmic
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 |
|---|---|---|---|---|---|---|
| Mckesson Medical-Surgical Inc. Corporate Office | UDI-DI | 2022-05-25 | Class II | Environmental control | Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21. | 1 Box |
Recalls
3 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 |
|---|---|---|---|---|---|
| 2024-02-02 | Class II | Under Investigation by firm | Pack and pouch label is missing the manufacturing and expiration date. | 3,000 units (US and OUS) | |
| 2018-11-30 | Class II | Process control | Certain lots are missing a protective sheath component over the silicone tip, which may result in the silicone tip breaking or detaching at the metal tube component. If the tip becomes detached during a procedure while in the eye, the fragm | 3430 units | 2020-05-01 |
| 2014-05-06 | Class II | Packaging process control | Contains a sharp tip needle when the product should contain a blunt tip cannula | 9970 units | 2014-09-05 |
| 2010-12-17 | Not classified | Component change control | Restricted or no fluid flow for Visitec High Viscosity Injector. | 1500 units | 2013-07-03 |
| 2010-12-17 | Not classified | Component change control | Restricted or no fluid flow for Visitec High Viscosity Injector. | 7614 units | 2013-07-03 |
| 2010-12-17 | Not classified | Component change control | Restricted or no fluid flow for Visitec High Viscosity Injector. | 2480 units | 2013-07-03 |
| 2010-12-17 | Not classified | Component change control | Restricted or no fluid flow for Visitec High Viscosity Injector. | 3990 units | 2013-07-03 |
| 2010-12-17 | Not classified | Component change control | Restricted or no fluid flow for Visitec High Viscosity Injector. | 1000 units | 2013-07-03 |
| 2010-12-17 | Not classified | Component change control | Restricted or no fluid flow for Visitec High Viscosity Injector. | 2545 units | 2013-07-03 |
| 2008-09-15 | Not classified | Employee error | Product labeled as 4 mm High Viscosity Injector tip contains a 6 mm tip. | 1485 units | 2012-02-29 |
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.