510(k) · Cleared
ClearedBenz Methafilcon a Optical Blank, Benz Methafilcon a Spherical and Toric Soft (Hydrophilic) Contact Lenses for Daily Wer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Benz Research and Development Corp. · LPL Lenses, Soft Contact, Daily Wear
Cleared on Feb 27, 1998 after a 24-day review. The FDA summary names no predicate by number. 3 later devices descend from it.
- Decided
- Feb 27, 1998
- Review
- 24 days
- Class
- Class II
- Product code
- LPL
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 2 citing it directly.
- This deviceK980418 Benz Methafilcon a Optical Blank, Benz Methafilcon a Spherical and…Benz Research and Development Corp. · 1998
- Descendant · cites it directly · 1 of its ownK023989 Contaflex 55 (Methafilcon) Spherical Soft Contact Lens for Daily…Contamac, Ltd. · 2003
- Descendant · 2 generations on · 0 of its ownK133403 Firesoft-Sihy. IC Daily Wear Contact Lenses, Firesoft-55 Daily Wear…Firestone Optics, Inc. · 2014
- Descendant · cites it directly · 0 of its ownK011577 Ocu-Flex 55 Spherical, Toric,Thin Zone Toric,Aspherical,Toric…Ocu-Ease Optical Products, Inc. · 2001
Most influential descendants
Showing 3 of 3 · See all- K023989Contaflex 55 (Methafilcon) Spherical Soft Contact Lens for Daily Wear (Clear and Tinted…Contamac, Ltd. · 2003 · cites it directly1descendant
- K133403Firesoft-Sihy. IC Daily Wear Contact Lenses, Firesoft-55 Daily Wear Contact Lenses…Firestone Optics, Inc. · 2014 · 2 generations on0descendants
- K011577Ocu-Flex 55 Spherical, Toric,Thin Zone Toric,Aspherical,Toric Aspherical and Thin Zone…Ocu-Ease Optical Products, Inc. · 2001 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K980418 | Benz Methafilcon a Optical Blank, Benz Methafilcon a Spherical and Toric Soft… | Benz Research and Development Corp. | 1998 | — |
| +1 | K023989 | Contaflex 55 (Methafilcon) Spherical Soft Contact Lens for Daily Wear (Clear… | Contamac, Ltd. | 2003 | — |
| +2 | K133403 | Firesoft-Sihy. IC Daily Wear Contact Lenses, Firesoft-55 Daily Wear Contact… | Firestone Optics, Inc. | 2014 | — |
| +1 | K011577 | Ocu-Flex 55 Spherical, Toric,Thin Zone Toric,Aspherical,Toric Aspherical and… | Ocu-Ease Optical Products, Inc. | 2001 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2014 | 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 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?
The FDA summary names no predicate by number.
What descends from it? (3)
2 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, K023989 (Contamac, Ltd., 2003) has gone furthest, with 1 descendant of its own.
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.
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 BENZ methafilcon A soft (hydrophilic) spherical and. toric contact lenses will be made from clear methafilcon A optical blanks and indicated for the correction of visual acuity in aphakic and non-aphakic persons with non-diseased eyes to be worn in daily wear regimens. The spherical lenses are available from +20.00 to -20.00 diopters and will mask up to 1.50 diopters of astigmatism where it does not interfere with visual acuity. The toric lenses are…
Read the full statement (132 words)
The BENZ methafilcon A soft (hydrophilic) spherical and. toric contact lenses will be made from clear methafilcon A optical blanks and indicated for the correction of visual acuity in aphakic and non-aphakic persons with non-diseased eyes to be worn in daily wear regimens.
The spherical lenses are available from +20.00 to -20.00 diopters and will mask up to 1.50 diopters of astigmatism where it does not interfere with visual acuity.
The toric lenses are available from +20.00 to -20.00 diopters and with up to 4.50 diopters of astigmatic correction.
The BENZ methafilcon A optical blanks are lathed into a soft (hydrophilic) spherical or toric hemispherical shell. The spherical lenses have a spherical base curve and the toric lenses have a non-spherical base curve.
The lenses may be disinfected using chemical disinfection systems.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K980418 · printed Nov 5, 2026
Cite this page
510(k) Report. “K980418: Benz Methafilcon a Optical Blank, Benz Methafilcon a Spherical and Toric Soft (Hydrophilic) Contact Lenses for Daily Wer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K980418
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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