510(k) Report

510(k) · Cleared

Cleared

Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A, hexafocon B, tisilfocon A)

K223394510(k) SpecialCleared Dec 7, 202229-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

Visionary Optics, LLC · HQD Lens, Contact (Other Material) - Daily

Cleared on Dec 7, 2022 as substantially equivalent to K171950 (Visionary Optics, LLC, 2017) and 1 other predicate after a 29-day review. Its family tree reaches back 10 generations to 1994. 5 later devices descend from it.

Decided
Dec 7, 2022
Review
29 days
Class
Class II
Product code
HQD
Recalls
None
Predicates
2

Its longest line of descent runs back 10 generations to K943177 (1994). 25 ancestors in all, the oldest P860022 (1987). 5 later devices descend from it, 2 citing it directly.

  1. Root · 10 generations backK943177 Boston (R) 7 - 30(Enflufocon a)Polymer Technology Corp. · 1994 · Recalled
  2. 6 generations between
  3. 3 generations backK171404 BOSTON XO (hexafocon A), BOSTON XO2 (hexafocon B)Bausch + Lomb, Incorporated · 2017
  4. 2 generations backK180616 OPTIMUM GP (roflufocon D, roflurocon E) Daily Wear Contact Lens…Contamac, Ltd. · 2018
  5. 1 generation backK212631 Optimum Infinite (tisilfocon A) Daily Wear Contact LensesContamac, Ltd. · 2022
  6. This deviceK223394 Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E…Visionary Optics, LLC · 2022
  7. Descendant · cites it directly · 4 of its ownK233325 Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E…Visionary Optics, LLC · 2024
  8. Descendant · 2 generations on · 3 of its ownK240618 Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens…Acuity Polymers, Inc. · 2024
  9. Descendant · cites it directly · 0 of its ownK242393 Acuity 181™ (tisilfocon A) and Acuity 181™ (tisilfocon A) with…Acuity Polymers, Inc. · 2024
  10. Descendant · 3 generations on · 0 of its ownK241398 SDJMASTERVISION (fluoroxyfocon A) Rigid Gas Permeable Contact LensesTianjin Mastervision Technology Co., Ltd. · 2024
  11. Descendant · 3 generations on · 0 of its ownK241571 BostonSight® Specialty LensesBoston Foundation For Sight, Inc. D/B/A Bostonsight · 2024
Show all 10 generations
  1. Root · 10 generations backK943177 Boston (R) 7 - 30(Enflufocon a)Polymer Technology Corp. · 1994 · Recalled
  2. 9 generations backK000795 Rigid Gas Permeable Contact LensPolymer Technology · 2000
  3. 8 generations backK020006 Dyna Intra-Limbal LensLens Dynamics, Inc. · 2002
  4. 7 generations backK053124 Boston ES (Enflufocon a), Boston EO (Enflufocon B) and Boston XO…Bausch & Lomb, Incorporated · 2006
  5. 6 generations backK071266 Boston X02 (Hexafocon B) Rigid Gas Permeable Contact LensBausch & Lomb, Inc. · 2007 · Recalled
  6. 5 generations backK153066 BostonSight IC Corneal Lens, BostonSight IC Scleral LensBoston Foundation For Sight · 2016
  7. 4 generations backK161461 BostonSight PD Prosthetic DeviceBostonsight · 2016 · Recalled
  8. 3 generations backK171404 BOSTON XO (hexafocon A), BOSTON XO2 (hexafocon B)Bausch + Lomb, Incorporated · 2017
  9. 2 generations backK180616 OPTIMUM GP (roflufocon D, roflurocon E) Daily Wear Contact Lens…Contamac, Ltd. · 2018
  10. 1 generation backK212631 Optimum Infinite (tisilfocon A) Daily Wear Contact LensesContamac, Ltd. · 2022
  11. This deviceK223394 Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E…Visionary Optics, LLC · 2022

Most influential descendants

Showing 5 of 5 · See all
  • K233325Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A…Visionary Optics, LLC · 2024 · cites it directly4descendants
  • K240618Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens; Acuity 100™ (hexafocon…Acuity Polymers, Inc. · 2024 · 2 generations on3descendants
  • K242393Acuity 181™ (tisilfocon A) and Acuity 181™ (tisilfocon A) with Tangible™ Hydra-PEG®…Acuity Polymers, Inc. · 2024 · cites it directly0descendants
  • K241398SDJMASTERVISION (fluoroxyfocon A) Rigid Gas Permeable Contact LensesTianjin Mastervision Technology Co., Ltd. · 2024 · 3 generations on0descendants
  • K241571BostonSight® Specialty LensesBoston Foundation For Sight, Inc. D/B/A Bostonsight · 2024 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−10K943177Boston (R) 7 - 30(Enflufocon a)Polymer Technology Corp.19941
−9K000795Rigid Gas Permeable Contact LensPolymer Technology2000—
−8K020006Dyna Intra-Limbal LensLens Dynamics, Inc.2002—
−7K053124Boston ES (Enflufocon a), Boston EO (Enflufocon B) and Boston XO (Hexafocon a)…Bausch & Lomb, Incorporated2006—
−6K071266Boston X02 (Hexafocon B) Rigid Gas Permeable Contact LensBausch & Lomb, Inc.20072
−5K153066BostonSight IC Corneal Lens, BostonSight IC Scleral LensBoston Foundation For Sight2016—
−4K161461BostonSight PD Prosthetic DeviceBostonsight20161
−3K171404BOSTON XO (hexafocon A), BOSTON XO2 (hexafocon B)Bausch + Lomb, Incorporated2017—
−2K180616OPTIMUM GP (roflufocon D, roflurocon E) Daily Wear Contact Lens, HEXA100…Contamac, Ltd.2018—
−1K212631Optimum Infinite (tisilfocon A) Daily Wear Contact LensesContamac, Ltd.2022—
0 (this device)K223394Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon…Visionary Optics, LLC2022—
+1K233325Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon…Visionary Optics, LLC2024—
+2K240618Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens; Acuity 100™…Acuity Polymers, Inc.2024—
+1K242393Acuity 181™ (tisilfocon A) and Acuity 181™ (tisilfocon A) with Tangible™…Acuity Polymers, Inc.2024—
+3K241398SDJMASTERVISION (fluoroxyfocon A) Rigid Gas Permeable Contact LensesTianjin Mastervision Technology Co., Ltd.2024—
+3K241571BostonSight® Specialty LensesBoston Foundation For Sight, Inc. D/B/A Bostonsight2024—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198710
199420
199510
199710
199910
200020
200110
200220
200410
201720
201810

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202450
FIG. 1 — Lineage of K223394, 1994–2024Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K240618 Acuity 200™ (fluoroxyfocon A) Rigid Gas…score 19.4 · 12 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K171950Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A…
Summary page 5
…Contact Lens (roflufocon D, roflufocon E, hexafocon A, hexafocon B)” Manufactured by Visionary Optics LLC 510(k) number; K171950 x “Optimum Infinite (tisilfocon A) Daily Wear Contact Lenses” Manufactured by Contamac Ltd.…
Visionary Optics, LLC2017—
*K212631Optimum Infinite (tisilfocon A) Daily Wear Contact Lenses
Summary page 5
…number; K171950 x “Optimum Infinite (tisilfocon A) Daily Wear Contact Lenses” Manufactured by Contamac Ltd. 510(k) number; K212631 IV. DEVICE DESCRIPTION The Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A, hexafocon…
Contamac, Ltd.2022—

What descends from it? (5)

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

NumberDeviceApplicantDecidedDescendants
K233325Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A…Visionary Optics, LLC20244
K242393Acuity 181™ (tisilfocon A) and Acuity 181™ (tisilfocon A) with Tangible™ Hydra-PEG®…Acuity Polymers, Inc.20240

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?

  • The line of descent spans 28 years and passes through 10 companies; a new generation was cleared every 1.8 years on median.
  • 4 of the 25 ancestors have a recall of any class.
  • Of its descendants, K233325 (Visionary Optics, LLC, 2024) has gone furthest, with 4 descendants of its own.

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. 2022, this device’s year, is highlighted.

FDA decisions per year · HQD

5in 2024

2007: 42008: 52009: 22011: 22012: 22014: 12016: 72017: 92018: 52019: 22020: 12021: 32022: 32023: 32024: 52026 (partial year): 1
2007high 9 (2017) · low 0 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HQD

80in 2024

2007: 78 days median2008: 100 days median2016: 119 days median2017: 66 days median2018: 53 days median2021: 123 days median2022: 29 days median2023: 77 days median2024: 80 days median
2007high 123 (2021) · low 29 (2022)2026

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

Recalls per year · HQD

1in 2010

2010: 1
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

2007: 62008: 82009: 122010: 22011: 72012: 102013: 152014: 262015: 52016: 12017: 32019: 52020: 22021: 32022: 32023: 82024: 32025: 2
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200747806
2008510008
20092—012
20100—12
20112—07
20122—010
20130—015
20141—026
20150—05
2016711901
201796603
201855300
20192—05
20201—02
2021312303
202232903
202337708
202458003
20250—02
20261—0—

What is it indicated for?

The Visionary Optics Scleral Contact Lens for daily wear is indicated for use for the management of multiple ocular conditions, such as, degenerations that lead to an irregular corneal shape (e.g. keratoconus, keratoglobus, pellucid marginal degeneration, Salzmann's Nodular Degeneration), dystrophies (e.g. Cogan's dystrophy, Granular Corneal Dystrophy, Lattice Corneal Dystrophy,), post-surgery (e.g. corneal transplant, LASIK, radial keratotomy), and…

Read the full statement (224 words)

The Visionary Optics Scleral Contact Lens for daily wear is indicated for use for the management of multiple ocular conditions, such as, degenerations that lead to an irregular corneal shape (e.g. keratoconus, keratoglobus, pellucid marginal degeneration, Salzmann's Nodular Degeneration), dystrophies (e.g. Cogan's dystrophy, Granular Corneal Dystrophy, Lattice Corneal Dystrophy,), post-surgery (e.g. corneal transplant, LASIK, radial keratotomy), and corneal scarring from infection or trauma.

The Visionary Optics Scleral Contact Lens for daily wear is also indicated for therapeutic management of ocular surface disease including dry eye (e.g. ocular manifestations of Graft-versus-Host disease, Sjogren's syndrome, dry eye syndrome), limbal stem cell deficiency (e.g. Stevens-Johnson syndrome, chemical and thermal burns, radiation, filamentary keratitis), epidermal ocular disorders, disorders of the skin (e.g. atopy, ectodermal dysplasia), neurotrophic keratitis (e.g. Herpes simplex. Herpes zoster, Familial Dysautonomia), and corneal exposure (e.g. anatomic, paralytic) that might benefit from the presence of an expanded tear reservoir and protection against an adverse environment. When prescribed for therapeutic use for distorted cornea or ocular surface disease, the Visionary Optics Scleral Contact Lens may incidentally provide correction of refractive error in persons with myopia, hyperopia, astigmatism or presbyopia.

Eye care practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be cleaned and disinfected using a chemical (not heat) lens care system.

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K223394: Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A, hexafocon B, tisilfocon A).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K223394

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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