# MVN: Lens, Contact, (Disposable)

- Device class: 2; regulation: 21 CFR 886.5925; FDA's rule: 510(k) required
- FDA decisions: 26
- Recalls: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2003: 1
- 2005: 3
- 2006: 4
- 2007: 1
- 2008: 2
- 2011: 1
- 2013: 1
- 2015: 2
- 2020: 2
- 2026: 1

## Most-cited predicates
- K061948: Proclear (Omafilcon a) Daily Disposable/Daily Wear Soft Contact Lens (2006), cited by 5
- K050213: Freshlook One-Day Color Contact Lens (2005), cited by 5
- K984273: Focus Dailies Visitint (Nelfilcon a) One-Day Contact Lens (1999), cited by 4
- K130331: Sauflon Clariti 1 Day (Somofilcon a) Soft (Hydrophilic) Daily Disposable Contact Lens with UV Blocker (2013), cited by 3
- K051900: Acuvue (Etafilcon a) Contact Lens, Clear and with Visibility Tint with UV Blocker, for Daily Wear (2005), cited by 3
- K020389: Biomedics 52 (Ocufilcon B) UV Blocking Daily Wear Soft Contact Lens (2002), cited by 3
- K010636: Focus Dailies (Nelfilcon a) One-Day Soft Contact Lenses, Focus Dailies Progressives (Nelfilcon a) One-Day Soft Contact (2001), cited by 3
- K003826: Focus Dailies Progressives (2001), cited by 3
- K061157: Soflens One Day Plus Disposable (Hilafilcon B) Visibility Tinted Contact Lens (2006), cited by 3
- K080632: CLEAR1-Day Hioxifilcon Daily Disposable Soft Contact Lens (2008), cited by 3

Source page: https://510kreport.com/product-code/MVN
Data by year (CSV): https://510kreport.com/product-code/MVN.csv