TransEquator (VTE)
TransEquator (VTE): 1 catalogue number listed by Volk Optical Inc., United States, under Lens, Fundus, Hruby, Diagnostic. 1 manufacturer in China is registered for this product code.
1manufacturer
1catalogue number
1recall
Who Else Makes It
Registered in Beijing.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Beijing Hongdee Corporation | Beijing | Beijing | Private-label distributor | 43 |
Record
| Listed by | Volk Optical Inc., United States |
|---|---|
| FDA product code | HJI |
| Device type | Lens, Fundus, Hruby, Diagnostic |
| Device class | Class 1 |
| Regulation | 21 CFR 886.1395 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2016-09-29 |
| Record revised | 2020-09-30 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| VTE | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Heine Omega 180 | Sontec Instruments, Inc. | 2 |
| PDT Laser (Vpdt) | Volk Optical Inc. | 1 |
| Alcon Grieshaber | Alcon Laboratories, Inc. | 1 |
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 |
|---|---|---|---|---|---|
| 2015-02-27 | Class III | Other | Mislabeling. The incorrect lot number was engraved on the anodized aluminum ring. The correct lot number is BE03356; however, BD03356 was engraved on the ring in error. | 78 units | 2016-02-04 |
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.