Disposable Infusion Sleeve for 2.2 Mm Phaco Needle Including Test Chamber
Catalogue number 3008.IRD22, 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 | 2025-08-12 (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 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 3008.IRD22 | 6 | In distribution |
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.