510(k) · Cleared
ClearedEni-Eye SH Toric (Efrofilcon a) Soft Hydrophilic Toric Contact Lens for Daily Wear, Multifocal Contact Lens, Keratoconus
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Soflex Limited · LPL Lenses, Soft Contact, Daily Wear
Cleared on Jul 28, 2011 after a 181-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Jul 28, 2011
- Review
- 181 days
- Class
- Class II
- Product code
- LPL
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LPL? 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 LPL device
- #1 K243868 Pegavision (Toufilcon B) Daily Disposable Soft…score 16.8 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it?
No later submission names this one as a predicate yet.
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.
How does its category compare?
All LPL devicesLPL Lenses, Soft Contact, Daily Wear: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · LPL
12in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LPL
202in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LPL
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LPL
216in 2025
MAUDE reports naming product code LPL, 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 | 3 | 281 | 1 | 280 |
| 2008 | 10 | 104 | 0 | 214 |
| 2009 | 6 | 260 | 1 | 137 |
| 2010 | 9 | 244 | 0 | 222 |
| 2011 | 12 | 170 | 5 | 377 |
| 2012 | 12 | 131 | 1 | 250 |
| 2013 | 17 | 135 | 0 | 151 |
| 2014 | 15 | 102 | 1 | 179 |
| 2015 | 12 | 120 | 1 | 161 |
| 2016 | 21 | 112 | 0 | 193 |
| 2017 | 9 | 98 | 11 | 280 |
| 2018 | 21 | 56 | 0 | 257 |
| 2019 | 11 | 115 | 0 | 205 |
| 2020 | 10 | 158 | 1 | 117 |
| 2021 | 8 | 88 | 0 | 110 |
| 2022 | 9 | 212 | 1 | 126 |
| 2023 | 10 | 167 | 0 | 178 |
| 2024 | 12 | 128 | 0 | 297 |
| 2025 | 12 | 202 | 1 | 216 |
| 2026 | 10 | 90 | 1 | — |
What is it indicated for?
The Eni-Eye SH Toric (Efrofilcon A) Soft (hydrophilic) Contact Lens for Daily Wear is indicated for daily wear for the correction of refractive astigmatism with non-diseased eyes that may exhibit refractive and/ar corneal astigmatism. The lens may be disinfected using a chemical disinfection system. The Eni-Eye 0 SH Multi (Efrofilcon A) Soft (hydrophilic) Multifocal Contact Lens for Daily Wear is indicated for daily wear for the correction of refractive…
Read the full statement (305 words)
The Eni-Eye SH Toric (Efrofilcon A) Soft (hydrophilic) Contact Lens for Daily Wear is indicated for daily wear for the correction of refractive astigmatism with non-diseased eyes that may exhibit refractive and/ar corneal astigmatism. The lens may be disinfected using a chemical disinfection system.
The Eni-Eye 0 SH Multi (Efrofilcon A) Soft (hydrophilic) Multifocal Contact Lens for Daily Wear is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic and/or non aphakic persons with non-diseased eyes. The lenses may be disinfected using a chemical disinfection system.
The Eni-Eye Q SH Multi Toric (Efrofilcon A) Soft (hydrophilic) Multifocal Contact Lens for Daily Wear is designed to correct ametropia (myopia and hyperopia), presbiopia, and corneal astigmatism in aphakic and/or non aphakic persons with non-diseased eyes. The lenses may be disinfected using a chemical disinfection system.
The ENI-EYE SH Soft K (Efrofilcon A) Soft (hydrophilic) Keratoconus and irregular cornea Contact Lens for Daily Wear is indicated for daily wear for persons requiring keratoconus management and for the correction of refractive ametropia (myopia and hyperopia) in aphakic and non-aphakic persons that may exhibit refractive and/or corneal astigmatism, or post-refractive surgery corneal irregularity such as irregular astigmatism up to 2.00 D that does not interfere with visual acuity. The lens may be disinfected with a chemical or heat disinfection system.
The Eni-Eye SH Soft K Toric (Efrofilcon A) Soft (hydrophilic) Keratoconus and irregular cornea Contact Lens for Daily Wear is indicated for daily wear for persons requiring keratoconus management and for the correction of refractive ametropia (myopia and hyperopia) in aphakic and non-aphakic persons that may exhibit refractive and/or corneal astigmatism, or post-refractive surgery corneal irregularity such as irregular astigmatism up to 2MODS that does not interfere with visual acuity. The lens may be disinfected with a chemical or heat disinfection system.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K110261 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110261: Eni-Eye SH Toric (Efrofilcon a) Soft Hydrophilic Toric Contact Lens for Daily Wear, Multifocal Contact Lens, Keratoconus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110261
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026