# K030842: Eni-Eye Q Toric (Acofilcon) Soft (Hydrophilic) Multifocal Contact Lens for Daily Wear, Eni-Eye (Acofilcon) Soft (Hydrop

- Pathway: 510(k) (Traditional)
- Applicant: Soflex Contact Lens Industries, Ltd.
- Decided: Jun 6, 2003 after 81 days
- Product code: LPL (Lenses, Soft Contact, Daily Wear)
- Device class: 2
- Regulation: 21 CFR 886.5925
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Eni-Eye Q Toric (acofilcon A) Soft (hydrophilic) Multifocal Contact Lens for Daily Wear is designed to correct ametropia (myopia and hyperopia), presbiopia, and corneal astigmatism in aphakic and/or non aphakic persons with nondiseased eyes. The lenses may be disinfected using a chemical disinfection system. The Eni-Eye Q (acofilcon A) Soft (hydrophilic) Multifocal Contact Lens for Daily Wear is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic and/or non aphakic persons with nondiseased eyes. The lenses may be disinfected using a chemical disinfection system. The Eni-Eye Toric (acofilcon A) Soft (hydrophilic) Contact Lens for Daily Wear is indicated for daily wear for the correction of astigmatism in persons with nondiseased eyes that may exhibit refractive and/or corneal astigmatism. The lenses may be disinfected using a chemical disinfection system.

Source page: https://510kreport.com/device/K030842
Methodology: https://510kreport.com/methodology