# K042242: Alden HP (Hioxifilcon B) Sphere & Toric Soft Contact Lenses

- Pathway: 510(k) (Special)
- Applicant: Alden Optical Labs., Inc.
- Decided: Sep 15, 2004 after 27 days
- Product code: LPL (Lenses, Soft Contact, Daily Wear)
- Device class: 2
- Regulation: 21 CFR 886.5925
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices 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.

## Most influential descendants
- K060821: Specialeyes 50 and Specialeyes 49 Shpere and Toric Soft Contact Lenses (2006), 0 descendants of its own

## Recalls of this device
- Nov 3, 2017 · Class II · Z-0986-2018: Contact lenses lack sterility assurance.
- Nov 3, 2017 · Class II · Z-0989-2018: Contact lenses lack sterility assurance.
- Nov 3, 2017 · Class II · Z-0990-2018: Contact lenses lack sterility assurance.

## Indications for use
The Alden HP 55 (methafilcon A) and Alden HP 59G (hioxifilcon A) Sphere 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 myopia or hyperopia, and/or possess refractive astigmatism not exceeding 10 Diopters, They are available for either conventional wear or planned replacement modalities.

Source page: https://510kreport.com/device/K042242
Methodology: https://510kreport.com/methodology