510(k) · Cleared
Recalled · Class III · 2018Boston X02 (Hexafocon B) Rigid Gas Permeable Contact Lens
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 15, 2007 as substantially equivalent to K000795 (Polymer Technology, 2000) and 3 other predicates after a 100-day review. Its family tree reaches back 4 generations to 1994. 26 later devices descend from it. It has been recalled 2 times.
- Decided
- Aug 15, 2007
- Review
- 100 days
- Class
- Class II
- Product code
- HQD
- Recalls
- 2
- Predicates
- 4
Its longest line of descent runs back 4 generations to K943177 (1994). 8 ancestors in all. 26 later devices descend from it, 6 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 deviceK071266 Boston X02 (Hexafocon B) Rigid Gas Permeable Contact LensBausch & Lomb, Inc. · 2007
- 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 26 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 26 · 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 |
|---|---|---|---|---|---|
| −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) | K071266 | Boston X02 (Hexafocon B) Rigid Gas Permeable Contact Lens | Bausch & Lomb, Inc. | 2007 | — |
| +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 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2016 | 3 | 0 |
| 2017 | 2 | 0 |
| 2018 | 3 | 0 |
| 2019 | 2 | 0 |
| 2021 | 2 | 0 |
| 2022 | 3 | 0 |
| 2023 | 3 | 0 |
| 2024 | 5 | 0 |
| 2026 | 1 | 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? (4)
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 |
|---|---|---|---|
| * | K000795 | Rigid Gas Permeable Contact LensSummary page 1…ic, irregular corneas, and orthkeratology). The BOSTON X0 2 is substantially equivalent to the currently marketed BOSTON XO cleared in 510(k) Premarket Notification Nos. K000795 on May 26, 200, K001960 on August 28, 2000, K053124 on January 30, 2006 and K011945 on September 12, 2001. The difference between… | 2000 |
| * | K001960 | Rigid Gas Permeable Contact LensSummary page 1…nd orthkeratology). The BOSTON X0 2 is substantially equivalent to the currently marketed BOSTON XO cleared in 510(k) Premarket Notification Nos. K000795 on May 26, 200, K001960 on August 28, 2000, K053124 on January 30, 2006 and K011945 on September 12, 2001. The difference between the two devices is a ch… | 2000 |
| * | K053124 | Boston ES (Enflufocon a), Boston EO (Enflufocon B) and Boston XO (Hexafocon a) Rigid Gas…Summary page 1…ON X0 2 is substantially equivalent to the currently marketed BOSTON XO cleared in 510(k) Premarket Notification Nos. K000795 on May 26, 200, K001960 on August 28, 2000, K053124 on January 30, 2006 and K011945 on September 12, 2001. The difference between the two devices is a change in the component ratios… | 2006 |
| * | K011945 | Rigid Gas Permeable Contact Lens SolutionSummary page 1…ent to the currently marketed BOSTON XO cleared in 510(k) Premarket Notification Nos. K000795 on May 26, 200, K001960 on August 28, 2000, K053124 on January 30, 2006 and K011945 on September 12, 2001. The difference between the two devices is a change in the component ratios.… | 2001 |
What descends from it? (26)
See all 266 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K153066 | BostonSight IC Corneal Lens, BostonSight IC Scleral Lens | 2016 | 20 |
| K183167 | Boston ES (enflufocon A) Rigid Gas Permeable Contact Lens; Boston EO (enflufocon B)… | 2019 | 5 |
| K120996 | Fluoroperm 30 Paragon HDS Fluoroperm 60 Paragon HDS 100 Fluoroperm 92 Fluoroperm 151… | 2012 | 1 |
| K181579 | eLens Rigid Gas Permeable Contact Lens for Daily Wear, eLens Rigid Gas Permeable Contact… | 2018 | 0 |
| K160859 | OPTIMUM GP OK Daily Wear Contact Lens (roflufocon D & E) | 2016 | 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 8 ancestors has a recall of any class.
- Of its descendants, K153066 (Boston Foundation For Sight, 2016) has gone furthest, with 20 descendants of its own.
- 6 other devices also cite its predicate K000795.
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?
The BOSTON X02 Gas Permeable Contact Lens is indicated for the daily wear correction of refractive ametropia (myopia, hyperopia, astigmatism, and presbyopia) in aphakic and not-aphakic persons with non-diseased eyes. The lens 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…
Read the full statement (113 words)
The BOSTON X02 Gas Permeable Contact Lens is indicated for the daily wear correction of refractive ametropia (myopia, hyperopia, astigmatism, and presbyopia) in aphakic and not-aphakic persons with non-diseased eyes.
The lens 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 lens is also indicated for daily wear in an orthokeratology fitting program for the temporary reduction of myopia of up to 5.00 diopters in non-diseased eyes. Note: To maintain the orthokeratology effect of myopia reduction, lens wear must be continued on a prescribed wearing schedule.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071266 · printed Nov 5, 2026
Cite this page
510(k) Report. “K071266: Boston X02 (Hexafocon B) Rigid Gas Permeable Contact Lens.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K071266
Report an extraction error
Are you the manufacturer?
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