Dutch Ophthalmic USA, Inc.
Dutch Ophthalmic USA, Inc. has 3 FDA enforcement events on this register (3 product records) between 2019 and 2021: 3 device; the busiest year was 2021 with 2.
0% of its events are Class I; the most common class is Class II (3). 2 events are listed as ongoing; the recalling firm's address is in NH.
Recall classification reflects the relative degree of health hazard. Event counts depend on a firm's size and product range; they are not a comparison of one firm with another.
Enforcement events
| Initiated | Product (first record) | Type | Class | Records | Status |
|---|---|---|---|---|---|
| 14 Apr 2021 | Illuminated Stepped Laser Probe Curved-for use in combination with 23G vitrectomy system Product Code: 7510.ALC | Device | Class II | 1 | Ongoing |
| 25 Feb 2021 | Disposable Replacement Backflush Brush Needles (23 gauge/0.6mm)-for use in vitreoretinal surgery Product Number: labeled as 1281.B1D, product is 1281.B1D06 | Device | Class II | 1 | Terminated |
| 21 May 2019 | The device is a 25-gauge infusion line that is part of 25-gauge surgical pack labeled TDC Vitrectomy Pack VGPC 25g , Product Number 8525.201. | Device | Class II | 1 | Ongoing |
By type and class
Class I: 0% of this firm's events; 18% of all events on the register.
Events by year
Questions and answers
How many FDA recalls has Dutch Ophthalmic USA, Inc. had?
3 enforcement events (3 product records) on this register, 2019–2021: 3 device.
Are any Dutch Ophthalmic USA, Inc. recalls ongoing?
2 events are listed as ongoing in the current openFDA export.
What class are Dutch Ophthalmic USA, Inc. recalls?
3 Class II. 0% are Class I against 18% of all events on the register. Class reflects the relative degree of health hazard of the product, not the firm.
Where does this data come from?
openFDA food, drug and device enforcement reports (CC0), export dated 28 Sep 2026.
Provenance
Source: openFDA enforcement reports (CC0), export dated 28 Sep 2026. Firm names are grouped exactly as FDA spells them; the same company can appear under several spellings. Only organisations are shown. See the methodology.