510(k) · Cleared
Recalled · Class III · 2018Boston XO (Hexafocon a), Boston EO (Enflufocon B) and Boston ES (Enflufocon a) Rigid Gas Permeable Contact Lenses
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bausch & Lomb, Inc. · HQD Lens, Contact (Other Material) - Daily
Cleared on Aug 2, 2007 as substantially equivalent to K053124 (Bausch & Lomb, Incorporated, 2006) and 1 other predicate after a 112-day review. Its family tree reaches back 4 generations to 1994. 14 later devices descend from it. It has been recalled 2 times.
- Decided
- Aug 2, 2007
- Review
- 112 days
- Class
- Class II
- Product code
- HQD
- Recalls
- 2
- Predicates
- 2
Its longest line of descent runs back 4 generations to K943177 (1994). 7 ancestors in all. 14 later devices descend from it, 5 citing it directly.
- Root · 4 generations backK943177 Boston (R) 7 - 30(Enflufocon a)Polymer Technology Corp. · 1994 · Recalled
- 3 generations backK000795 Rigid Gas Permeable Contact LensPolymer Technology · 2000
- 2 generations backK020006 Dyna Intra-Limbal LensLens Dynamics, Inc. · 2002
- 1 generation backK053124 Boston ES (Enflufocon a), Boston EO (Enflufocon B) and Boston XO…Bausch & Lomb, Incorporated · 2006
- This deviceK071043 Boston XO (Hexafocon a), Boston EO (Enflufocon B) and Boston ES…Bausch & Lomb, Inc. · 2007
- Descendant · cites it directly · 9 of its ownK162005 Acuity 100 (hexafocon A) Rigid Gas Permeable Contact LensAcuity Polymers, Inc. · 2016
- Descendant · 2 generations on · 7 of its ownK201194 Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact LensAcuity Polymers, Inc. · 2020
- Descendant · 3 generations on · 6 of its ownK203571 Acuity 200 (fluoroxyfocon A) Rigid Gas Permeable Contact LensAcuity Polymers, Inc. · 2021
- Descendant · cites it directly · 5 of its ownK183167 Boston ES (enflufocon A) Rigid Gas Permeable Contact Lens; Boston EO…Bausch & Lomb, Incorporated · 2019
- Descendant · 4 generations on · 4 of its ownK233325 Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E…Visionary Optics, LLC · 2024
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K162005Acuity 100 (hexafocon A) Rigid Gas Permeable Contact LensAcuity Polymers, Inc. · 2016 · cites it directly9descendants
- K201194Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact LensAcuity Polymers, Inc. · 2020 · 2 generations on7descendants
- K203571Acuity 200 (fluoroxyfocon A) Rigid Gas Permeable Contact LensAcuity Polymers, Inc. · 2021 · 3 generations on6descendants
- K183167Boston ES (enflufocon A) Rigid Gas Permeable Contact Lens; Boston EO (enflufocon B)…Bausch & Lomb, Incorporated · 2019 · cites it directly5descendants
- K233325Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A…Visionary Optics, LLC · 2024 · 4 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K943177 | Boston (R) 7 - 30(Enflufocon a) | Polymer Technology Corp. | 1994 | 1 |
| −3 | K000795 | Rigid Gas Permeable Contact Lens | Polymer Technology | 2000 | — |
| −2 | K020006 | Dyna Intra-Limbal Lens | Lens Dynamics, Inc. | 2002 | — |
| −1 | K053124 | Boston ES (Enflufocon a), Boston EO (Enflufocon B) and Boston XO (Hexafocon a)… | Bausch & Lomb, Incorporated | 2006 | — |
| 0 (this device) | K071043 | Boston XO (Hexafocon a), Boston EO (Enflufocon B) and Boston ES (Enflufocon a)… | Bausch & Lomb, Inc. | 2007 | — |
| +1 | K162005 | Acuity 100 (hexafocon A) Rigid Gas Permeable Contact Lens | Acuity Polymers, Inc. | 2016 | — |
| +2 | K201194 | Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens | Acuity Polymers, Inc. | 2020 | — |
| +3 | K203571 | Acuity 200 (fluoroxyfocon A) Rigid Gas Permeable Contact Lens | Acuity Polymers, Inc. | 2021 | — |
| +1 | K183167 | Boston ES (enflufocon A) Rigid Gas Permeable Contact Lens; Boston EO… | Bausch & Lomb, Incorporated | 2019 | — |
| +4 | K233325 | Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon… | Visionary Optics, LLC | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 5 | 0 |
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
What was it cleared against? (2)
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 | Decided |
|---|---|---|---|
| * | K053124 | Boston ES (Enflufocon a), Boston EO (Enflufocon B) and Boston XO (Hexafocon a) Rigid Gas…Summary page 1…16) Device classification: Class 11 (21 CFR 886.5916) Pro Code: HOD Predicate Devices: K053124 and K013762: Boston XO (hexafocon A), Boston EQ (enflufocon B), Boston ES (enflufocon A) 510(k)… | 2006 |
| * | K013762 | Rigid Gas Permeable Contact LensSummary page 1…classification: Class 11 (21 CFR 886.5916) Pro Code: HOD Predicate Devices: K053124 and K013762: Boston XO (hexafocon A), Boston EQ (enflufocon B), Boston ES (enflufocon A) 510(k)… | 2002 |
What descends from it? (14)
See all 145 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K162005 | Acuity 100 (hexafocon A) Rigid Gas Permeable Contact Lens | 2016 | 9 |
| K183167 | Boston ES (enflufocon A) Rigid Gas Permeable Contact Lens; Boston EO (enflufocon B)… | 2019 | 5 |
| K081443 | Menicon Z Rigid Gas Permeable Contact Lens | 2008 | 1 |
| K181579 | eLens Rigid Gas Permeable Contact Lens for Daily Wear, eLens Rigid Gas Permeable Contact… | 2018 | 0 |
| K103561 | Menicon Z (Tisilfocon a) Rigid Gas Permeable Contact Lens | 2011 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 3, 2018 | Class III | Z-2982-2018 | Process control | Vials labeled for the prescriptions contained incorrect lenses |
| Jul 3, 2018 | Class III | Z-2981-2018 | Process control | Vials labeled for the prescriptions contained incorrect lenses |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 13 years and passes through 5 companies; a new generation was cleared every 3.8 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K162005 (Acuity Polymers, Inc., 2016) has gone furthest, with 9 descendants of its own.
- 7 other devices also cite its predicate K053124.
How does its category compare?
All HQD devicesHQD Lens, Contact (Other Material) - Daily: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · HQD
5in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · HQD
80in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HQD
1in 2010
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HQD
2in 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?
Boston XO (hexafocon A), Boston EO (enflufocon B) and Boston ES (enflufocon A) Rigid Gas Permeable Contact Lenses are 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. Also, the lenses may be prescribed in otherwise non-diseased eyes that require a rigid contact lens for the management of irregular corneal conditions such as keratoconus, pellucid marginal degeneration, or following penetrating keratoplasty or refractive (e.g. LASIK) surgery. The lenses may be disinfected using a chemical disinfection system only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071043 · printed Nov 5, 2026
Cite this page
510(k) Report. “K071043: Boston XO (Hexafocon a), Boston EO (Enflufocon B) and Boston ES (Enflufocon a) Rigid Gas Permeable 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/K071043
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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