Visitec® EdgeAhead®
Knife 2.25MM 60DEG BEV Down Crescent (5/SP)
12manufacturers in China registered for this device type
17catalogue numbers in this listing
22recalls on this code
Who Else Makes It
Concentrated in Jiangsu (9), Shanghai (1), Shandong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Hospital & Homecare IMP. & EXP. Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 179 |
| 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 |
| 2nd Sight Medical Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 1 |
| Shaanxi Xingmao Industry Co., Ltd. | Xi An | Shaanxi | Private-label distributor | 1 |
Record
| Listed by | Beaver-Visitec International, Ltd, United Kingdom |
|---|---|
| FDA product code | HNN |
| Device type | Knife, 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 | 2024-06-06 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Radiation Sterilization |
| Supplied sterile | Yes |
| Storage | Special storage condition: Store in a dry place. |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 581118 | In distribution | |
| 581137 | In distribution | |
| 581141 | In distribution | |
| 581109 | In distribution | |
| 581125 | In distribution | |
| 581107 | In distribution | |
| 581121 | In distribution | |
| 581111 | In distribution | |
| 581119 | In distribution | |
| 581129 | In distribution | |
| 581112 | In distribution | |
| 581116 | In distribution | |
| 581139 | In distribution | |
| 581127 | In distribution | |
| 581123 | In distribution | |
| 581105 | In distribution | |
| 581135 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Ambler Surgical | Ambler Surgical, LLC | 283 |
| Mani Ophthalmic Knife | Mani, Inc. | 234 |
| Unique Edge | Unique Technologies, Inc. | 186 |
| Sharpoint | Surgical Specialties México, S. de R.L. de C.V. | 162 |
| MSI Precision Specialty Instruments | MED Saver, Inc. | 154 |
| Mastel Precision Surgical Instruments, Inc. | Mastel Surgical Inc. | 146 |
| Anodyne Surgical | Psi/Eye-Ko, Inc. | 115 |
| Ophthalmic Knife | Ovation International | 81 |
| Ophthalmic Knife | Katena Products, Inc. | 72 |
| Premier Edge® Microsurgical Knives | Oasis Medical, Inc. | 69 |
| Micro Feather Disposable Ophthalmic Scalpel with plastic handle | Feather Safety Razor Co., Ltd. | 63 |
| ExactEtch | Diamatrix | 63 |
Showing 12 of 434. All products under Knife, Ophthalmic
Recalls
8 of these are Class II. Class II means a temporary or reversible health consequence. Class III is unlikely to cause harm at all → typically a labelling or documentation fault. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2024-05-10 | Class II | Process control | The wrong configuration of the blade was in the package. The bevel was on the opposite side, instead of being in front (bevel up) it was in the back (bevel down). | 1300 units | |
| 2024-05-10 | Class II | Process control | The wrong configuration of the blade was in the package. The bevel was on the opposite side, instead of being in front (bevel up) it was in the back (bevel down). | 126 units | |
| 2023-10-10 | Class II | Under Investigation by firm | One lot of Part Number 373025, Xstar Kojo Safety Slit Knife 2.5mm 45 bevel up, incorrectly contains a bevel down blade instead of a bevel up blade. | 2160 units | |
| 2023-08-25 | Class II | Under Investigation by firm | One lot of Conventional Crescent Knife 2.5mm, 55 degrees bevel-up contains a bevel down blade. | 1980 units | |
| 2022-11-30 | Class II | Under Investigation by firm | Packaging sterile barrier has been compromised. Open seals can lead to a loss of device sterility and may lead to infection | 599 units (US): 410 units; 189 kits | |
| 2021-10-08 | Class II | Under Investigation by firm | Product packaged as Beaver Xstar Crescent Knife, 2.5mm, 55 degrees bevel-down blades contain bevel-up blades | 5950 eaches | |
| 2019-03-12 | Class II | Packaging process control | Mislabeled. The package labeling indicates a size 2.4mm, 45 degree Double Bevel knife however, the marking on device shows a 2.75mm size device | 196 boxes (10units/box) | 2020-08-11 |
| 2019-02-19 | Class III | Error in labeling | The product contains a misprinted expiration date on the peel pack. Both were printed as “180615”, which is the lot number. The Lot number is correct. | 97 boxes (10units/box) | 2020-07-21 |
| 2018-06-18 | Class II | Packaging process control | Mislabel of product 373726 Lot 6001700 with 374891 Lot 6001701 on individual packages within the correctly labeled shelf carton. | 440 | 2019-10-30 |
| 2010-04-06 | Not classified | Packaging process control | A field action was initiated due to a recent customer complaint from Japan there is a labeling mixup and that some of the BD Visitec EdgeAhead MVR Knife 0.90mm (20G), REF 585230, shelf packs may contain BD Visitec EdgeAhead Slit Knife 2.3m | 1170 (US 810, OUS 360) | 2012-08-06 |
| 2006-12-26 | Not classified | Other | Product sterility may be compromised due to incomplete package seal | 28,224 units | 2016-03-07 |
| 2006-12-26 | Not classified | Other | Product sterility may be compromised due to incomplete package seal | 249,000 units | 2016-03-07 |
| 2006-12-26 | Not classified | Other | Product sterility may be compromised due to incomplete package seal | 47,304 units | 2016-03-07 |
| 2006-12-26 | Not classified | Other | Product sterility may be compromised due to incomplete package seal | 91,704 units | 2016-03-07 |
| 2006-12-26 | Not classified | Other | Product sterility may be compromised due to incomplete package seal | 33,300 units | 2016-03-07 |
| 2006-12-26 | Not classified | Other | Product sterility may be compromised due to incomplete package seal | 2,000 units | 2016-03-07 |
| 2006-12-26 | Not classified | Other | Product sterility may be compromised due to incomplete package seal | 136,032 units | 2016-03-07 |
| 2006-12-26 | Not classified | Other | Product sterility may be compromised due to incomplete package seal | 2,934 units | 2016-03-07 |
| 2006-12-26 | Not classified | Other | Product sterility may be compromised due to incomplete package seal | 43,600 units | 2016-03-07 |
| 2006-12-26 | Not classified | Other | Product sterility may be compromised due to incomplete package seal | 29,952 units | 2016-03-07 |
| 2006-02-28 | Not classified | Other | Product labeled as a 2.8 mm may contain a 3.2 mm Xstar slit knife | 3430 units | 2006-09-13 |
| 2004-09-16 | Not classified | Other | Blade may become detached from the handle | 6945 units | 2005-02-17 |
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.