# K033919: Ciba Vision (Lotrafilcon B) Spherical, Toric, Multifocal and Toric Multifocal Designs

- Pathway: 510(k) (Traditional)
- Applicant: Ciba Vision Corporation
- Decided: Mar 12, 2004 after 85 days
- Product code: LPL (Lenses, Soft Contact, Daily Wear)
- 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 P810005 (1981). 5 ancestors in all.
94 later devices descend from it; 10 cite it directly.
0 of 100 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020139: Focus Excelens (Lotrafilcon B) Spherical, Toric and Multifocal Design, Ciba Vision Corporation (2002) Summary page 1.

## Most influential descendants
- K052560: Biofinity (Comfilcon a) Soft Contact Lens (2005), 74 descendants of its own
- K100221: INTELLIWAVE3 (2010), 32 descendants of its own
- K073459: Ciba Vision (Lotrafilcon B) Soft Contact Lenses (2008), 17 descendants of its own
- K071736: Aquair (Enfilcon a) Soft (Hydrophilic) Contact Lens (2008), 14 descendants of its own
- K141348: Visco Soft Contact Lens (2015), 12 descendants of its own

## Recalls of this device
- Jan 11, 2007 · Not classified · Z-0427-2007: Reduced Ion Permeability

## Indications for use
The CIBA Vision® (lotrafilcon B) spherical soft contact lens is indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes and with up to approximately 1.50 diopters of astigmatism that does not interfere with visual acuity. The CIBA Vision® Toric (lotrafilcon B) soft contact lens is indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes with 10.00 diopters (D) or less of astigmatism. The CIBA Vision® Progressives (lotrafilcon B) soft contact lens is indicated for the optical correction of refractive ametropia (myopia and hyperopia) and/or presbyopia in phakic or aphakic persons with non-diseased eyes who may require a reading addition of +3.00 diopters (D) or less and who may have up to approximately 1.50 diopters of astigmatism. The CIBA Vision® Progressive Toric (lotrafilcon B) soft contact lens is indicated for the optical correction of refractive ametropia (myopia, hyperopia, astigmatism and presbyopia) in phakic or aphakic persons with non-diseased eyes. The lenses may be worn by persons who have 10.00 diopters (D) or less of refractive and/or corneal astigmatism. The lenses may be prescribed for daily wear with removal for cleaning and disinfection (chemical, not heat) prior to reinsertion, as recommended by the eye care professional.

Source page: https://510kreport.com/device/K033919
Methodology: https://510kreport.com/methodology