PMA · Approved
ApprovedBoston Equalens (Itaflurofocon a)/Equalens II (Oprifocon a) Rigid Gas Permeable Contact Lens
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bausch & Lomb · MWL Lens, Contact (Rigid Gas Permeable), Extended Wear
Approved on Nov 30, 1987 through premarket approval, which rests on the device’s own clinical evidence after a 546-day review. 25 later devices descend from it.
- Decided
- Nov 30, 1987
- Review
- 546 days
- Class
- Class III
- Product code
- MWL
- Recalls
- None
25 later devices descend from it, 3 citing it directly.
- This deviceP860022 Boston Equalens (Itaflurofocon a)/Equalens II (Oprifocon a) Rigid…Bausch & Lomb · 1987
- Descendant · cites it directly · 24 of its ownK022128 Boston Equalens II (Oprifocon a) Rigid Gas Permeable Contact LensBausch & Lomb, Incorporated · 2002
- Descendant · 2 generations on · 20 of its ownK153066 BostonSight IC Corneal Lens, BostonSight IC Scleral LensBoston Foundation For Sight · 2016
- Descendant · cites it directly · 19 of its ownK161461 BostonSight PD Prosthetic DeviceBostonsight · 2016 · Recalled
- Descendant · cites it directly · 14 of its ownK171404 BOSTON XO (hexafocon A), BOSTON XO2 (hexafocon B)Bausch + Lomb, Incorporated · 2017
- Descendant · 2 generations on · 9 of its ownK180616 OPTIMUM GP (roflufocon D, roflurocon E) Daily Wear Contact Lens…Contamac, Ltd. · 2018
Showing 5 of 25 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 25 · See all- K022128Boston Equalens II (Oprifocon a) Rigid Gas Permeable Contact LensBausch & Lomb, Incorporated · 2002 · cites it directly24descendants
- K153066BostonSight IC Corneal Lens, BostonSight IC Scleral LensBoston Foundation For Sight · 2016 · 2 generations on20descendants
- K161461BostonSight PD Prosthetic DeviceBostonsight · 2016 · cites it directly19descendants
- K171404BOSTON XO (hexafocon A), BOSTON XO2 (hexafocon B)Bausch + Lomb, Incorporated · 2017 · cites it directly14descendants
- K180616OPTIMUM GP (roflufocon D, roflurocon E) Daily Wear Contact Lens, HEXA100 (hexafocon A)…Contamac, Ltd. · 2018 · 2 generations on9descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | P860022 | Boston Equalens (Itaflurofocon a)/Equalens II (Oprifocon a) Rigid Gas… | Bausch & Lomb | 1987 | — |
| +1 | K022128 | Boston Equalens II (Oprifocon a) Rigid Gas Permeable Contact Lens | Bausch & Lomb, Incorporated | 2002 | — |
| +2 | K153066 | BostonSight IC Corneal Lens, BostonSight IC Scleral Lens | Boston Foundation For Sight | 2016 | — |
| +1 | K161461 | BostonSight PD Prosthetic Device | Bostonsight | 2016 | 1 |
| +1 | K171404 | BOSTON XO (hexafocon A), BOSTON XO2 (hexafocon B) | Bausch + Lomb, Incorporated | 2017 | — |
| +2 | K180616 | OPTIMUM GP (roflufocon D, roflurocon E) Daily Wear Contact Lens, HEXA100… | Contamac, Ltd. | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 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 |
Sources: FDA PMA database (decision fields and supplements), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MWL? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
Does it have a predicate?
PMA decisions do not claim a predicate device.
What descends from it? (25)
See all 253 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K022128 (Bausch & Lomb, Incorporated, 2002) has gone furthest, with 24 descendants of its own.
How does its category compare?
All MWL devicesMWL Lens, Contact (Rigid Gas Permeable), Extended Wear: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MWL
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MWL
Too few MWL 510(k)s in any year since 2007 to give a median.
Recalls per year · MWL
No recall names MWL since 2007.
Adverse event reports per year · MWL
1in 2025
MAUDE reports naming product code MWL, 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 | 0 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 2 |
| 2011 | 2 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 2 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 2 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 2 | — | 0 | 2 |
| 2020 | 4 | — | 0 | 1 |
| 2021 | 1 | — | 0 | 1 |
| 2022 | 4 | — | 0 | 1 |
| 2023 | 1 | — | 0 | 1 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/P860022 · printed Nov 6, 2026
Cite this page
510(k) Report. “P860022: Boston Equalens (Itaflurofocon a)/Equalens II (Oprifocon a) Rigid Gas Permeable Contact Lens.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P860022
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026