# K052703: Alden Classic (Polymacon) Multifocal (Spherical and Toric), Alden Classic 55 (Methafilcon a) Multifocal (Spherical

- Pathway: 510(k) (Traditional)
- Applicant: Alden Optical Labs., Inc.
- Decided: Nov 10, 2005 after 43 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
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.

## Recalls of this device
- Nov 3, 2017 · Class II · Z-0991-2018: Contact lenses lack sterility assurance.

## Indications for use
The Alden Classic (polymacon), Alden Classic 55 (methafilcon A), Alden HP 49 (hioxifilcon B) and Alden HP 59G (hioxifilcon A) Multifocal (Spherical and Toric) soft contact lenses for daily wear are indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with refractive ametropia (myopia, hyperopia, and astigmatism) and presbyopia. The lenses are available for either conventional or planned replacement modalities.

Source page: https://510kreport.com/device/K052703
Methodology: https://510kreport.com/methodology