Precision7™; Precision7™ for Astigmatism; Precision7™ Multifocal; Precision7™ Multifocal Toric (serafilcon A) Soft Conta

FDA premarket approval P220007 · Lenses, soft contact, extended wear

PMA numberP220007

Approval

Applicant
Alcon Laboratories, Inc.
Received
June 3, 2022
Decision date
April 25, 2023 (APPR)
Supplements
7, latest March 11, 2026
Product code
LPM – Lenses, Soft Contact, Extended Wear

Official FDA PMA record

Approval order statement

Approval for Precision7; Precision7 for Astigmatism; Precision7 Multifocal; Precision7 Multifocal Toric (serafilcon A) Soft Contact Lenses; Precision7 (serafilcon A) spherical soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes with up to approximately 1.50 diopters (D) of astigmatism that does not interfere with visual acuity.Precision7 for Astigmatism (serafilcon A) toric soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes who may have up to 6.00 diopters (D) of astigmatism, Precision7 Multifocal (serafilcon A) soft contact lenses are indicated for the optical correction of presbyopia with or without refractive ametropia (myopia and hyperopia) 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 that does not interfere with visual acuityPrecision7 Multifocal Toric (serafilcon A) soft contact lenses are indicated for the optical correction of presbyopia with or without refractive ametropia (myopia and hyperopia) 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 6.00 diopters (D) of astigmatism.The lenses are to be prescribed for extended wear for up to 6 continuous nights with removalfor disposal, or cleaning and disinfection (chemical, not heat) prior to reinsertion, as recommended by the eye care professional. Lenses should be discarded and replaced with a new pair each week, or more often, if recommended by the eye care professional.