EVA Vitrectomy Pack Gravity Input 20g
Catalogue number 8300.20G01, listed by D.o.r.c. Dutch Ophthalmic Research Center (International) B.V., Netherlands, under Instrument, Vitreous Aspiration And Cutting, Ac-Powered. 1 manufacturer in China is registered for this product code.
Who Else Makes It
Registered in Guangdong. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| ABA Medical Technology Co Ltd | Guang Dong | Guangdong | Contract manufacturer | 6 |
Record
| Listed by | D.o.r.c. Dutch Ophthalmic Research Center (International) B.V., Netherlands |
|---|---|
| FDA product code | HQE |
| Device type | Instrument, Vitreous Aspiration And Cutting, Ac-Powered |
| Device class | Class 2 |
| Regulation | 21 CFR 886.4150 |
| Establishment | Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K190875 |
| Record published | 2016-09-23 |
| Record revised | 2025-01-09 (version 7) |
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 |
| Distribution end date | 2024-12-31 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 8300.20G01 | 6 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Bausch + Lomb | Bausch & Lomb Incorporated | 108 |
| Unity | Alcon Laboratories, Inc. | 47 |
| Synergetics | Synergetics USA, Inc. | 44 |
| Bi-Blade® | Medical Instrument Development Laboratories, Inc. | 28 |
| Instrument, Vitreous Aspiration And Cutting, Ac-Powered | Medical Instrument Development Laboratories, Inc. | 21 |
| Alcon | Alcon Laboratories, Inc. | 14 |
| Constellation | Alcon Laboratories, Inc. | 9 |
| Stellaris | Bausch & Lomb Incorporated | 6 |
| EVA Nexus™ Posterior 25G TDC Pack | D.o.r.c. Dutch Ophthalmic Research Center (International) B.V. | 4 |
| EVA Nexus™ Posterior 23G TDC Pack | D.o.r.c. Dutch Ophthalmic Research Center (International) B.V. | 4 |
| EVA Nexus™ Posterior 27G TDC Pack | D.o.r.c. Dutch Ophthalmic Research Center (International) B.V. | 4 |
| Engauge, Vektor | Alcon Laboratories, Inc. | 3 |
Showing 12 of 65. All products under Instrument, Vitreous Aspiration And Cutting, Ac-Powered
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Dutch Ophthalmic USA, Inc. | 510(k) number | 2019-05-21 | Class II | Under Investigation by firm | Labeled 25-gauge surgical pack, TDC Vitrectomy Pack VGPC 25g, containing 23-gauge infusion line | 16 boxes |
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 |
|---|---|---|---|---|
| 2026-04-30 | Class II | Process design | An increase in incidence in complaints of a loose outer knife and reports of the outer knife becoming loose during use. | 2068 boxes totaling 12408 units |
| 2026-04-30 | Class II | Process design | An increase in incidence in complaints of a loose outer knife and reports of the outer knife becoming loose during use. | 261 boxes totaling 1566 units |
| 2026-04-30 | Class II | Process design | An increase in incidence in complaints of a loose outer knife and reports of the outer knife becoming loose during use. | 314 boxes, totaling 1884 units |
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.