Dutch Ophthalmic USA, Inc.
United StatesFDA applicant, unverified
- Devices
- 10
- FDA recalls
- 31 ongoing
At a glance
Market reach
- United States
- FDA recalls
What Dutch Ophthalmic USA, Inc. makes
Dutch Ophthalmic USA, Inc. manufactures ophthalmic surgical instruments and illumination systems, including vitrectomy tools like the Harmony Total Vitrectomy System and the Harmony Total TTC Vitrectomy System. Their portfolio also covers cryosurgical devices such as the CryoStar Cryosurgical System and the Ophthalmic Cryo Unit, as well as illumination probes like the Hexon Illumination System and fiber optic endoillumination probes. Additional offerings include microdiathermy systems, light sources like the Solux, and temporary keratoprostheses such as the Eckhardt Temporary Keratoprosthesis.
These devices are classified under FDA categories Class I and Class II, with regulatory submissions supported via the 510(k) pathway. The company’s products are listed in the FDA’s 510(k) registry. Dutch Ophthalmic USA, Inc. is based in the United States.
Catalogue
D.O.R.C. Hexon Illumination System Ref K973229
Regimes: 510(k) Registry: 510(k)D.O.R.C. Microdiathermy System Ref K962135
Regimes: 510(k) Registry: 510(k)D.O.R.C. Vfi/Vfe System Ref K954842
Regimes: 510(k) Registry: 510(k)D.O.R.C. Solux Light Source Ref K973757
Regimes: 510(k) Registry: 510(k)D.O.R.C. Cryostar Cryosurgical System Ref K012821
Regimes: 510(k) Registry: 510(k)Fiber Optic Endoillumination Probe Ref K980636
Regimes: 510(k) Registry: 510(k)D.O.R.C. Harmony Total Ttc Vitrectomy System Ref K010082
Regimes: 510(k) Registry: 510(k)Eckhardt Temporary Keratoprosthesis Ref K902491
Regimes: 510(k) Registry: 510(k)D.O.R.C. Harmony Total Vitrectomy System Ref K983797
Regimes: 510(k) Registry: 510(k)Ophthalmic Cryo Unit Ref K940373
Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 3 recalls initiated by Dutch Ophthalmic USA, Inc., the earliest on 2019-05-21 and the most recent on 2021-04-14. By recorded status: 2 ongoing and 1 terminated. The reasons filed fall into these groups: labeling or instructions for use. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
Recalls initiated per year
- 2017 0
- 2018 0
- 2019 1
- 2020 0
- 2021 2
- 2022 0
- 2023 0
- 2024 0
- 2025 0
- 2026 0
2021
- 14 Apr 2021 Z-2097-2021 Class II Ongoing Barcode label extended expiration date. Barcode located at the short side of the outer box shows 2025-10-27 when scanned, while the correct expiry date is 2024-10-01
- 25 Feb 2021 Z-2091-2021 Class II Terminated Mislabeled: 1281.B1D Disposable Replacement Backflush Brush Needles label states (20 gauge/0.9 mm) instead of the correct size of 23 gauge/0.6 mm and the correct product code 1281.B1D06
2019
- 21 May 2019 Z-2252-2021 Class II Open since 2019 Labeled 25-gauge surgical pack, TDC Vitrectomy Pack VGPC 25g, containing 23-gauge infusion line
Frequently asked questions
How many devices does Dutch Ophthalmic USA, Inc. have in the registry?
The registry currently lists 10 devices for Dutch Ophthalmic USA, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Dutch Ophthalmic USA, Inc.'s devices?
Among its 10 most recently registered devices, Dutch Ophthalmic USA, Inc. has devices listed in FDA 510(k) (10 devices).
What risk classes do Dutch Ophthalmic USA, Inc.'s devices fall under?
Among its 10 most recently registered devices, the classes recorded for Dutch Ophthalmic USA, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Dutch Ophthalmic USA, Inc.?
FDA recall records list 3 recalls initiated by Dutch Ophthalmic USA, Inc., the most recent initiated on 2021-04-14. 2 of them are recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Dutch Ophthalmic USA, Inc. in the registry?
The most recently registered devices listed for Dutch Ophthalmic USA, Inc. include D.O.R.C. HEXON ILLUMINATION SYSTEM, D.O.R.C. MICRODIATHERMY SYSTEM, D.O.R.C. VFI/VFE SYSTEM and D.O.R.C. SOLUX LIGHT SOURCE.