EVA Nexus™ Combined 25g TDC Pack
Catalogue number 9310.25G02, listed by D.o.r.c. Dutch Ophthalmic Research Center (International) B.V., Netherlands, under Unit, Phacofragmentation. 4 manufacturers in China are registered for this product code.
4manufacturers in China registered for this device type
1catalogue number
3recalls on this code
Who Else Makes It
Concentrated in Guangdong (2), Shanghai (1), Jiangsu (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Sanmina | Kunshan | Jiangsu | Contract manufacturer | 15 |
| Providence Enterprise Limited | Shenzhen | Guangdong | Contract manufacturer | 9 |
| ABA Medical Technology Co Ltd | Guang Dong | Guangdong | Contract manufacturer | 6 |
| Sterigenics Shanghai ETO Ltd. | Shanghai | Shanghai | Contract manufacturer | 65 |
Record
| Listed by | D.o.r.c. Dutch Ophthalmic Research Center (International) B.V., Netherlands |
|---|---|
| FDA product code | HQC |
| Device type | Unit, Phacofragmentation |
| Device class | Class 2 |
| Regulation | 21 CFR 886.4670 |
| Establishment | Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K213467 |
| Record published | 2022-07-08 |
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 |
|---|---|---|---|
| 9310.25G02 | 6 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Bausch + Lomb | Bausch & Lomb Incorporated | 109 |
| Alcon | Alcon Laboratories, Inc. | 95 |
| Oertli® | Oertli Instrumente AG | 66 |
| Laminar | Johnson & Johnson Surgical Vision, Inc. | 40 |
| Engauge | Alcon Laboratories, Inc. | 18 |
| Unity | Alcon Laboratories, Inc. | 18 |
| Constellation | Alcon Laboratories, Inc. | 16 |
| MST/Packard A1.7mm Phaco Tip Bent Dewey 30° | Microsurgical Technology, Inc. | 11 |
| Whitestar Signature | Johnson & Johnson Surgical Vision, Inc. | 10 |
| Alcon, Infiniti, MicroSmooth, ABS | Alcon Laboratories, Inc. | 10 |
| Compact Intuitiv | Johnson & Johnson Surgical Vision, Inc. | 9 |
| Alcon, Infiniti, Intrepid | Alcon Laboratories, Inc. | 9 |
Showing 12 of 619. All products under Unit, Phacofragmentation
Recalls Naming This Product
6 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| D.o.r.c. Dutch Ophthalmic Research Center (International) B.V. | 510(k) number | 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 |
| D.o.r.c. Dutch Ophthalmic Research Center (International) B.V. | 510(k) number | 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 |
| D.o.r.c. Dutch Ophthalmic Research Center (International) B.V. | 510(k) number | 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 |
| D.o.r.c. Dutch Ophthalmic Research Center (International) B.V. | 510(k) number | 2024-01-15 | Class II | Process control | When using those products you may experience difficulties to extend or retract the laser fiber, and in some occasions may also have difficulties to direct the laser fiber tip precisely. | 14 boxes x 6 units per box = 84 units |
| D.o.r.c. Dutch Ophthalmic Research Center (International) B.V. | 510(k) number | 2024-01-15 | Class II | Process control | When using those products you may experience difficulties to extend or retract the laser fiber, and in some occasions may also have difficulties to direct the laser fiber tip precisely. | 21 boxes x 6 units each = 126 units |
| D.o.r.c. Dutch Ophthalmic Research Center (International) B.V. | 510(k) number | 2024-01-15 | Class II | Process control | When using those products you may experience difficulties to extend or retract the laser fiber, and in some occasions may also have difficulties to direct the laser fiber tip precisely. | 13 boxes x 6 units per box = 78 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.