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Biofinity Energys (comfilcon A) Soft Contact Lenses

FDA PMA

Class III (US FDA PMA)

PMA P080011

by Coopervision Inc.

Identity

Trade Name
BIOFINITY (COMFILCON A) FDA PMA
Generic Name
Lenses, soft contact, extended wear FDA PMA

Identifiers

PMA Number
P080011 FDA PMA
FDA Product Code
LPM FDA PMA

Classification

Device Class
Class III FDA PMA
Legislation / Framework
21 CFR Part 886.5925 FDA PMA
Regulation Number
886.5925 FDA PMA
Advisory Committee
Ophthalmic FDA PMA
FDA Decision
APPR Approved FDA PMA

Biofinity Energys (comfilcon A) soft contact lenses are hydrophilic lenses indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes. These lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity, and are approved for extended wear for up to 6 nights and 7 days of continuous wear.

The lenses may be prescribed for either one week disposable wear or for frequent replacement with cleaning, disinfection and scheduled replacement. When prescribed for frequent replacement, the lenses must be cleaned and disinfected using a chemical disinfection system only. These lenses are manufactured by CooperVision, Inc. and are FDA PMA approved.

Frequently asked questions

What conditions can Biofinity Energys contact lenses correct?

Biofinity Energys contact lenses are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes. They can also be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity.

How long can Biofinity Energys contact lenses be worn continuously?

Biofinity Energys contact lenses may be prescribed for extended wear for up to 6 nights and 7 days of continuous wear. It is recommended that the contact lens wearer be first evaluated on a daily wear schedule prior to overnight wear.

What is the recommended replacement schedule for Biofinity Energys contact lenses?

Biofinity Energys contact lenses may be prescribed for either one week disposable wear or for frequent replacement with cleaning, disinfection and scheduled replacement. When prescribed for frequent replacement, the lenses must be cleaned and disinfected using a chemical disinfection system only.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Biofinity® sphere & Biofinity® XR sphere - CooperVision Germany, Biofinity® sphere – sphärische ... - CooperVision Germany, Biofinity® contact lenses | Disposable Monthly Contact Lenses ..., Biofinity Kontaktlinsen | Schnelle Lieferung von Lenstore, Biofinity (6 Linsen) – Kontaktlinsen | Lentiamo

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_PMA

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Manufacturer

Manufacturer
Coopervision Inc.
FDA Applicant
CooperVision, Inc.

Sources (1)

  • FDA PMA P080011 24 fields · synced Sep 18, 2026