# K091327: Alden HP 54 Sphee 7 Hip 54 Toric Contact Lenses, Alden HP 54 Multifocal &HP 54  Toric Multifocal Contact Lenses

- Pathway: 510(k) (Special)
- Applicant: Alden Optical Labs., Inc.
- Decided: Jun 25, 2010 after 416 days
- Product code: LPL (Lenses, Soft Contact, Daily Wear)
- Device class: 2
- Regulation: 21 CFR 886.5925
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 2 cite it directly.
0 of 3 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
- K230954: Samfilcon B Custom Contact Lens (2023), 0 descendants of its own
- K133403: Firesoft-Sihy. IC Daily Wear Contact Lenses, Firesoft-55 Daily Wear Contact Lenses, Firesoft-49G Daily Wear Contact Lens (2014), 0 descendants of its own

## Recalls of this device
- Nov 3, 2017 · Class II · Z-0985-2018: Contact lenses lack sterility assurance.
- Nov 3, 2017 · Class II · Z-0988-2018: Contact lenses lack sterility assurance.

## Indications for use
The Alden HP 54 Spherical soft contact lens is indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with refractive ametropia (myopia or hyperopia). The lens may be worn by persons who exhibit refractive astigmatism of 1.50 diopters or less where the astigmatism does not interfere with visual acuity. The Alden HP 54 Toric soft contact lens is indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes, with refractive ametropia (myopia or hyperopia), and/or possess refractive astigmatism not exceeding 10.00 diopters. The Alden HP 54 Multifocal soft contact lens is indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with refractive ametropia (myopia or hyperopia) and presbyopia, with add powers not exceeding 4.00 diopters. The lens may be worn by persons who exhibit refractive astigmatism of 1.50 diopters or less where the astigmatism does not interfere with visual acuity. The Alden HP 54 Toric Multifocal soft contact lens is indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes, with refractive ametropia (myopia or hyperopia), and/or possess refractive astigmatism not exceeding 10.00 diopters, and presbyopia with add powers not exceeding 4.00 diopters. The lenses are available for either conventional wear or planned replacement modalities.

Source page: https://510kreport.com/device/K091327
Methodology: https://510kreport.com/methodology