FDA product code MVN: Lens, Contact, (Disposable)
MVN is the FDA product code for lens, contact, (disposable). It is a Class II device, regulated under 21 CFR 886.5925 and reviewed by the Ophthalmic panel. FDA has cleared 26 510(k) submissions under MVN, 1 in the last five years, from 14 different applicants. The average 510(k) review took 84 days (median 64); 36 days on average over the last three years. FDA has posted 17 recalls for MVN devices, 6 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Lens, Contact, (Disposable) |
| Device class | Class II |
| Regulation | 21 CFR 886.5925 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for MVN
| Year | Clearances | Avg. review days |
|---|---|---|
| 2020 | 2 | 28 |
| 2026 | 1 | 36 |
Compare with all 510(k) review times · Search every MVN clearance
Top MVN applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Ciba Vision Corporation | 6 | 2005-05-27 |
| Bausch & Lomb, Inc. | 3 | 2011-10-25 |
| Alcon Laboratories, Inc. | 2 | 2020-09-22 |
| Yung Sheng Optical Co., Ltd. | 2 | 2015-06-15 |
| Sauflon Pharmaceuticals, Ltd. | 2 | 2013-07-26 |
9 more applicants have MVN clearances. See the full list in Caduvo.
Most recent MVN clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K261812 | HOYA Lamphun , Ltd. | HOYA Illumina (sorafilcon A) Daily Disposable Soft Contact Lens; HOYA Illumina (sorafilcon A) Toric Daily Disposable Soft Contact Lens; HOYA Illumina (sorafilcon A) Multifocal Daily Disposable Soft Contact Lens | 2026-07-07 | 36 |
| K202448 | Alcon Laboratories, Inc. | DAILIES AquaComfort Plus (DACP) / DACP FreshTech / DACP Toric / DACP Multifocal | 2020-09-22 | 27 |
| K202036 | Alcon Laboratories, Inc. | Focus DAILIES / Focus DAILIES Toric / Focus DAILIES Progressives, DAILIES AquaComfort Plus (DACP) / DACP FreshTech / DACP Toric / DACP Multifocal | 2020-08-21 | 29 |
| K150630 | Yung Sheng Optical Co., Ltd. | Eye Secret 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear, Eye Secret 55 UV Aspheric ( methafilcon A) Soft (hydrophilic) Contact lens for Daily Wear | 2015-06-15 | 96 |
| K143190 | Yung Sheng Optical Co., Ltd. | Eye Secret 38 UV Aspheric (polymacon) 1-Day Soft (hydrophilic) Contact Lens | 2015-01-16 | 72 |
Recalls for MVN devices
17 product recalls in 11 recall events; 6 initiated in the last five years and 6 still open. Most recent: 2026-08-12.
| Year | Recalls |
|---|---|
| 2017 | 2 |
| 2018 | 4 |
| 2024 | 1 |
| 2025 | 4 |
| 2026 | 1 |
Frequently asked questions
What is FDA product code MVN?
MVN is the FDA product code for lens, contact, (disposable). It is a Class II device, regulated under 21 CFR 886.5925 and reviewed by the Ophthalmic panel.
What device class is MVN?
Class II, regulation 21 CFR 886.5925. Typical premarket route: 510(k).
How long does a 510(k) take for product code MVN?
Across 26 cleared submissions the average was 84 days from receipt to decision (median 64).
Which companies have the most MVN clearances?
Ciba Vision Corporation (6); Bausch & Lomb, Inc. (3); Alcon Laboratories, Inc. (2); Yung Sheng Optical Co., Ltd. (2); Sauflon Pharmaceuticals, Ltd. (2).
Have MVN devices been recalled?
Yes: 17 product recalls across 11 recall events; the most recent began 2026-08-12.
Next steps
- Run an FDA pathway report with predicate devices for product code MVN
- Run a recall and safety report across every MVN manufacturer
- Watch product code MVN for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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