510(k) · Cleared

Cleared

Boston Equalens II (Oprifocon a) Rigid Gas Permeable Contact Lens

K022128510(k) TraditionalCleared Aug 22, 200252-day reviewClass II21 CFR 886.5916

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

Bausch & Lomb, Incorporated · HQD Lens, Contact (Other Material) - Daily

Cleared on Aug 22, 2002 as substantially equivalent to P860022 (Bausch & Lomb, 1987) after a 52-day review. Its family tree reaches back 1 generation to 1987. 24 later devices descend from it.

Decided: Aug 22, 2002
Review: 52 days
Class: Class II
Product code: HQD
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to P860022 (1987). 24 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 1 generation backP860022 Boston Equalens (Itaflurofocon a)/Equalens II (Oprifocon a) Rigid…Bausch & Lomb · 1987
This deviceK022128 Boston Equalens II (Oprifocon a) Rigid Gas Permeable Contact LensBausch & Lomb, Incorporated · 2002
Descendant · cites it directly · 20 of its ownK153066 BostonSight IC Corneal Lens, BostonSight IC Scleral LensBoston Foundation For Sight · 2016
Descendant · 2 generations on · 19 of its ownK161461 BostonSight PD Prosthetic DeviceBostonsight · 2016 · Recalled
Descendant · 3 generations on · 14 of its ownK171404 BOSTON XO (hexafocon A), BOSTON XO2 (hexafocon B)Bausch + Lomb, Incorporated · 2017
Descendant · 4 generations on · 9 of its ownK180616 OPTIMUM GP (roflufocon D, roflurocon E) Daily Wear Contact Lens…Contamac, Ltd. · 2018
Descendant · 3 generations on · 7 of its ownK212631 Optimum Infinite (tisilfocon A) Daily Wear Contact LensesContamac, Ltd. · 2022

Showing 5 of 24 descendants. See all descendants

Descendants cleared per year

2011high 5 (2024) · low 0 (2012)2026

Most influential descendants

Showing 5 of 24 · See all

K153066BostonSight IC Corneal Lens, BostonSight IC Scleral LensBoston Foundation For Sight · 2016 · cites it directly20descendants
K161461BostonSight PD Prosthetic DeviceBostonsight · 2016 · 2 generations on19descendants
K171404BOSTON XO (hexafocon A), BOSTON XO2 (hexafocon B)Bausch + Lomb, Incorporated · 2017 · 3 generations on14descendants
K180616OPTIMUM GP (roflufocon D, roflurocon E) Daily Wear Contact Lens, HEXA100 (hexafocon A)…Contamac, Ltd. · 2018 · 4 generations on9descendants
K212631Optimum Infinite (tisilfocon A) Daily Wear Contact LensesContamac, Ltd. · 2022 · 3 generations on7descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	P860022	Boston Equalens (Itaflurofocon a)/Equalens II (Oprifocon a) Rigid Gas…	Bausch & Lomb	1987	—
0 (this device)	K022128	Boston Equalens II (Oprifocon a) Rigid Gas Permeable Contact Lens	Bausch & Lomb, Incorporated	2002	—
+1	K153066	BostonSight IC Corneal Lens, BostonSight IC Scleral Lens	Boston Foundation For Sight	2016	—
+2	K161461	BostonSight PD Prosthetic Device	Bostonsight	2016	1
+3	K171404	BOSTON XO (hexafocon A), BOSTON XO2 (hexafocon B)	Bausch + Lomb, Incorporated	2017	—
+4	K180616	OPTIMUM GP (roflufocon D, roflurocon E) Daily Wear Contact Lens, HEXA100…	Contamac, Ltd.	2018	—
+3	K212631	Optimum Infinite (tisilfocon A) Daily Wear Contact Lenses	Contamac, Ltd.	2022	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2011	1	0
2016	2	0
2017	3	0
2018	2	0
2019	2	0
2021	2	0
2022	3	0
2023	3	0
2024	5	0
2026	1	0

FIG. 1 — Lineage of K022128, 1987–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

Planning a device in HQD? 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 HQD device

#1 K240618 Acuity 200™ (fluoroxyfocon A) Rigid Gas…score 19.4 · 12 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? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	P860022	Boston Equalens (Itaflurofocon a)/Equalens II (Oprifocon a) Rigid Gas Permeable Contact… Summary page 1 …s Permeable Contact Lenses 3. PREDICATE DEVICE The BOSTON* EQUALENS@(itafluorofocon A) Rigid Gas Permeable Contact Lens approved in Premarket Application, P860022, on November 30, 1987, has been selected as the predicate device for the BOSTON@EQUALENS@II (oprifocon A) Rigid Gas Per…	Bausch & Lomb	1987	—

Also cleared against P860022: 2 other devices →

What descends from it? (24)

See all 24

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

Number	Device	Applicant	Decided	Descendants
K153066	BostonSight IC Corneal Lens, BostonSight IC Scleral Lens	Boston Foundation For Sight	2016	20
K170001	Acuity 85 (Oprifocon A) Rigid Gas Permeable Contact Lens	Acuity Polymers, Inc.	2017	1
K103561	Menicon Z (Tisilfocon a) Rigid Gas Permeable Contact Lens	Menicon Co, Ltd.	2011	0

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

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has no recall.
Of its descendants, K153066 (Boston Foundation For Sight, 2016) has gone furthest, with 20 descendants of its own.
2 other devices also cite its predicate P860022.

How does its category compare?

All HQD devices

HQD Lens, Contact (Other Material) - Daily: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HQD

5in 2024

2007high 9 (2017) · low 0 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HQD

80in 2024

2007high 123 (2021) · low 29 (2022)2026

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

Recalls per year · HQD

1in 2010

2007high 1 (2010) · low 0 (2007)2026

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

Adverse event reports per year · HQD

2in 2025

2007high 26 (2014) · low 0 (2018)2025

MAUDE reports naming product code HQD, 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	4	78	0	6
2008	5	100	0	8
2009	2	—	0	12
2010	0	—	1	2
2011	2	—	0	7
2012	2	—	0	10
2013	0	—	0	15
2014	1	—	0	26
2015	0	—	0	5
2016	7	119	0	1
2017	9	66	0	3
2018	5	53	0	0
2019	2	—	0	5
2020	1	—	0	2
2021	3	123	0	3
2022	3	29	0	3
2023	3	77	0	8
2024	5	80	0	3
2025	0	—	0	2
2026	1	—	0	—

What is it indicated for?

The BOSTON EQUALENS II (oprifocon A) RGP contact lens is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia, astigmatism and presbyopia) in aphakic and not-aphakic persons with non-diseased eyes.

The lens may be disinfected using a chemical disinfection system only.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K022128 · printed Nov 4, 2026

Cite this page

510(k) Report. “K022128: Boston Equalens II (Oprifocon a) Rigid Gas Permeable Contact Lens.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K022128

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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