60d Clear
Catalogue number V60C, listed by Volk Optical Inc., United States, under Lens, Condensing, Diagnostic. 6 manufacturers in China are registered for this product code.
6manufacturers in China registered for this device type
1catalogue number
1recall
Who Else Makes It
Concentrated in Jiangsu (3), Shanghai (2), Beijing (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Beijing Hongdee Corporation | Beijing | Beijing | Private-label distributor | 43 |
| Taizhou City K&W International Trade Co., Ltd. | Jiangyan | Jiangsu | Repacker / relabeller | 38 |
| Lianyungang Tiannuo Optical Instrument Co., Ltd. | Lianyungang | Jiangsu | Contract manufacturer | 31 |
| 66 Vision Tech Co., Ltd. | Suzhou | Jiangsu | Private-label distributor | 24 |
| Shanghai Canton Optics Equipment Co., Ltd. | Shanghai | Shanghai | Manufacturer | 14 |
| Shanghai Mediworks Precision Instruments Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 13 |
Record
| Listed by | Volk Optical Inc., United States |
|---|---|
| FDA product code | HJL |
| Device type | Lens, Condensing, Diagnostic |
| Device class | Class 1 |
| Regulation | 21 CFR 886.1380 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2020-09-24 |
| Record revised | 2022-06-17 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| V60C | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| MaxLight® Standard 90D Slit Lamp Indirect Lens w/Large Ring | Ocular Instruments, Inc. | 6 |
| MaxField® Standard 90D Slit Lamp Indirect Lens w/Large Ring (Red) | Ocular Instruments, Inc. | 6 |
| MaxLight® Triple Two Panfundus Binocular Indirect Lens (Purple) | Ocular Instruments, Inc. | 6 |
| Righton | Right MFG. Co., Ltd. | 4 |
| Mediworks | Shanghai Mediworks Precision Instruments Co., Ltd. | 3 |
| Ophthalmoscopy Lens A.R. | Heine Optotechnik Gmbh & Co. KG. | 3 |
| MaxLight® Ultra Mag 60D Slit Lamp Indirect Lens (Green) | Ocular Instruments, Inc. | 2 |
| DirectView 4 Mirror NF w/ Handle | ION Vision, Inc. | 2 |
| SuperField® NC, Custom Color | Volk Optical Inc. | 1 |
| Osher Maxfield® 78D Slit Lamp Indirect Lens (Green) | Ocular Instruments, Inc. | 1 |
| MaxField® High Mag 78 Slit Lamp Indirect Lens (Purple) | Ocular Instruments, Inc. | 1 |
| MaxField® 60D Slit Lamp Indirect Lens (Purple) | Ocular Instruments, Inc. | 1 |
Showing 12 of 354. All products under Lens, Condensing, Diagnostic
Recalls
1 of these is Class III. 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 |
|---|---|---|---|---|---|
| 2012-10-25 | Class III | Employee error | The defect was with mis-engraving of the lot # directly on the product and its packaging. Mixed up device engraving of V20LC (lot # BB09213) with that from V60C (lot # BB09205). | 40 devices | 2013-06-11 |
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.