510(k) · Cleared

Recalled · Class II · 2017

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

K091327510(k) SpecialCleared Jun 25, 2010416-day reviewClass II21 CFR 886.5925Recalls 2

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Alden Optical Labs., Inc. · LPL Lenses, Soft Contact, Daily Wear

Cleared on Jun 25, 2010 after a 416-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 2 later devices descend from it. It has been recalled 2 times.

Decided: Jun 25, 2010
Review: 416 days
Class: Class II
Product code: LPL
Recalls: 2
Predicates: 0

2 later devices descend from it, 2 citing it directly.

This deviceK091327 Alden HP 54 Sphee 7 Hip 54 Toric Contact Lenses, Alden HP 54…Alden Optical Labs., Inc. · 2010
Descendant · cites it directly · 0 of its ownK230954 Samfilcon B Custom Contact LensBausch + Lomb, Incorporated · 2023
Descendant · cites it directly · 0 of its ownK133403 Firesoft-Sihy. IC Daily Wear Contact Lenses, Firesoft-55 Daily Wear…Firestone Optics, Inc. · 2014

Most influential descendants

Showing 2 of 2 · See all

K230954Samfilcon B Custom Contact LensBausch + Lomb, Incorporated · 2023 · cites it directly0descendants
K133403Firesoft-Sihy. IC Daily Wear Contact Lenses, Firesoft-55 Daily Wear Contact Lenses…Firestone Optics, Inc. · 2014 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K091327	Alden HP 54 Sphee 7 Hip 54 Toric Contact Lenses, Alden HP 54 Multifocal &HP 54…	Alden Optical Labs., Inc.	2010	—
+1	K230954	Samfilcon B Custom Contact Lens	Bausch + Lomb, Incorporated	2023	—
+1	K133403	Firesoft-Sihy. IC Daily Wear Contact Lenses, Firesoft-55 Daily Wear Contact…	Firestone Optics, Inc.	2014	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2014	1	0
2023	1	0

FIG. 1 — Lineage of K091327, 2010–2023Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in LPL? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new LPL device

#1 K243868 Pegavision (Toufilcon B) Daily Disposable Soft…score 16.8 · 5 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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What was it cleared against?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (2)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K230954	Samfilcon B Custom Contact Lens	Bausch + Lomb, Incorporated	2023	0
K133403	Firesoft-Sihy. IC Daily Wear Contact Lenses, Firesoft-55 Daily Wear Contact Lenses…	Firestone Optics, Inc.	2014	0

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Nov 3, 2017	Class II	Z-0985-2018	Process design	Contact lenses lack sterility assurance.
Nov 3, 2017	Class II	Z-0988-2018	Process design	Contact lenses lack sterility assurance.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Of its descendants, K230954 (Bausch + Lomb, Incorporated, 2023) has gone furthest, with 0 descendants of its own.

How does its category compare?

All LPL devices

LPL Lenses, Soft Contact, Daily Wear: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.

FDA decisions per year · LPL

12in 2025

2007high 21 (2016) · low 3 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LPL

202in 2025

2007high 281 (2007) · low 56 (2018)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LPL

1in 2025

2007high 11 (2017) · low 0 (2008)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LPL

216in 2025

2007high 377 (2011) · low 110 (2021)2025

MAUDE reports naming product code LPL, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	3	281	1	280
2008	10	104	0	214
2009	6	260	1	137
2010	9	244	0	222
2011	12	170	5	377
2012	12	131	1	250
2013	17	135	0	151
2014	15	102	1	179
2015	12	120	1	161
2016	21	112	0	193
2017	9	98	11	280
2018	21	56	0	257
2019	11	115	0	205
2020	10	158	1	117
2021	8	88	0	110
2022	9	212	1	126
2023	10	167	0	178
2024	12	128	0	297
2025	12	202	1	216
2026	10	90	1	—

What is it indicated for?

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…

Read the full statement (221 words)

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.

Indications for use as stated in the FDA 510(k) statement.

https://510kreport.com/device/K091327 · printed Nov 5, 2026

Cite this page

510(k) Report. “K091327: Alden HP 54 Sphee 7 Hip 54 Toric Contact Lenses, Alden HP 54 Multifocal &HP 54 Toric Multifocal Contact Lenses.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K091327

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026