# K050065: Focus Dailies, Focus Dailies Toric and Focus Dailies Progressives

- Pathway: 510(k) (Traditional)
- Applicant: Ciba Vision Corporation
- Decided: May 27, 2005 after 135 days
- Product code: MVN (Lens, Contact, (Disposable))
- Device class: 2
- Regulation: 21 CFR 886.5925
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to P820021 (1983). 7 ancestors in all.
11 later devices descend from it; 1 cites it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K963487: Dailies (Nelfilcon a) One-Day Soft Contact Lens, Ciba Vision Corporation (1996). Our reading of the summary gave K943487, FDA’s number for BIO74-PF Crown & Bridge Alloy (Jeneric/Pentron, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “CIBA Vision's Focus DAILIES (nelfilcon A) One-Day Contact Lens clear…”. Summary page 2.
- K984273: Focus Dailies Visitint (Nelfilcon a) One-Day Contact Lens, Ciba Vision Corporation (1999) Summary page 1.
- K010636: Focus Dailies (Nelfilcon a) One-Day Soft Contact Lenses, Focus Dailies Progressives (Nelfilcon a) One-Day Soft Contact, Ciba Vision Corporation (2001) Summary page 1.
- K033701: Focus Dailies, Focus Dailies Toric and Focus Dailies Progressives One-Day Soft Contact Lenses, Ciba Vision Corporation (2003) Summary page 1.
- K003826: Focus Dailies Progressives, Ciba Vision Corporation (2001) Summary page 1.

## Most influential descendants
- K083216: Ciba Vision (Nelfilcon a) One-Day Soft Contact Lenses (2009), 10 descendants of its own
- K153643: Focus DAILIES, Focus DAILIES Toric, Focus DAILIES Progressives (2016), 7 descendants of its own
- K180398: Focus DAILIES / Focus DAILIES Toric / Focus DAILIES Progressives, DAILIES AquaComfort Plus (DACP) / DACP Toric / DACP Multifocal, FreshLook One-Day, DAILIES Total1, DAILIES Total1 Multifocal (2018), 4 descendants of its own
- K181454: DAILIES AquaComfort Plus, DAILIES AquaComfort Plus FreshTech, DAILIES AquaComfort Plus Toric and DAILIES AquaComfort Plus Multifocal (2018), 2 descendants of its own
- K180669: Focus DAILIES / Focus DAILIES Toric / Focus DAILIES Progressives, DAILIES AquaComfort Plus (DACP) / DACP Toric / DACP Multifocal, FreshLook One-Day, DAILIES Total 1 / DAILIES Total 1 Multifocal (2018), 2 descendants of its own

## Recalls of this device
- Jul 25, 2006 · Not classified · Z-1402-06: Misbranding; Lenses (-0.75) are labeled with the incorrect power of (-1.50) .

## Indications for use
Focus® DAILIES® and Focus® DAILIES® Toric (nelfilcon A) ONE-DAY CONTACT LENSES are indicated for daily wear for the optical correction of refractive ametropia (myopia, hyperopia and astigmatism) in not-aphakic persons with non-diseased eyes. Focus® DAILIES® Progressives (nelfilcon A) One-Day soft contact lenses are indicated for daily wear for the optical correction of presbyopia in not aphakic persons with non-diseased eyes who require a reading addition of +3.00 diopters (D) or less and who may have 2.00 diopters (D) or less of astigmatism that does not interfere with visual acuity. The lenses are to be prescribed for single-use daily disposable wear. DAILIES lenses are not intended to be cleaned or disinfected and should be discarded after a single use.

Source page: https://510kreport.com/device/K050065
Methodology: https://510kreport.com/methodology