FDA product code · Ophthalmic
LPLLenses, Soft Contact, Daily Wear
Product code LPL covers Lenses, Soft Contact, Daily Wear, a Class II device regulated under 21 CFR 886.5925. FDA has cleared 486 devices in this code, 12 of them in the last 12 months. Median review time across the 486 most recent decisions is 84 days. openFDA lists 70 recall records against this code.
Updated · ingest status · JSON
- Class
- Class II
- Regulation
- 21 CFR 886.5925
- Review panel
- Ophthalmic
- Clearances
- 486
What is happening in LPL right now?
LPL (Lenses, Soft Contact, Daily Wear) has three findings, most consequential first. 1 recall opened in the last 12 months and not yet terminated (Class II) (Z-0326-2026). Clearances are running 74% slower — a median 146 days over the last 12 months against 84 days all-time (elapsed calendar days, not FDA review days) (LPL:review_time:12m). The code is crowded, scoring 74 of 100 — 138 companies hold a clearance here and 12 arrived in the last 12 months (LPL:crowding).
| Finding | How much it matters | FDA records |
|---|---|---|
| Recall | Class II recall | Z-0326-2026 |
| Review time | Context | LPL:review_time:12m |
| Crowding | Context | LPL:crowding |
Sources checked: predicate ancestry, recalls, adverse events, new entrants, review time, crowding. Composed . Every finding carries the record ids it was derived from; nothing here is an estimate.
How many devices has FDA cleared in LPL?
FDA has cleared 486 devices under product code LPL since the 510(k) programme began in 1976, 12 of them in the last 12 months.
Source: openFDA device/510k · retrieved
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260507 | Interojo 45 (inofilcon A) Soft (Hydrophilic) Silicone Hydrogel Contact Lens with GrabSoo Plus | INTEROJO, Inc. | |
| K253352 | Pegavision (Polymacon) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Polymacon) Soft (Hydrophilic) Contact Lenses; Pegavision (Polymacon) Color Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Polymacon) Color Soft (Hydrophilic) Contact Lenses | Pegavision Corporation | |
| K261299 | Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Toufilcon B) Soft (Hydrophilic) Contact Lenses | Pegavision Corporation | |
| K253885 | PUSCON WATER BALANCE-1DAY TINT (omafilcon A) SOFT (HYDROPHILIC) CONTACT LENS; PUSCON WATER BALANCE-1DAY COLOR (omafilcon A) SOFT (HYDROPHILIC) CONTACT LENSES | GEO MEDICAL CO., LTD. | |
| K254269 | Saview SH Optic 38 UV (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens; Saview SH Optic 38 UV toric (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens; Saview SH Optic 38 UV multifocal (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens | St. shine Optical Co., Ltd. | |
| K252385 | Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Toufilcon B) Soft (Hydrophilic) Contact Lenses | Pegavision Corporation | |
| K254052 | DAILIES TOTAL1®; DAILIES TOTAL1® Multifocal | Alcon Laboratories, Inc. | |
| K251683 | Deseyne (vifilcon C) Daily Disposable Soft (hydrophilic) Contact Lens with UV Blocking for Presbyopia (EDOF) | Bruno Vision Care, LLC | |
| K250364 | Saview SH Optic 38 UV (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens; Saview SH Optic 38 UV toric (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens; Saview SH Optic 38 UV multifocal (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens | St. shine Optical Co., Ltd. | |
| K244009 | Pure Plus UV Aspheric (Otufilcon A) Silicone Soft (hydrophilic) Contact Lens for Daily Wear (Daily Wear); Pure Plus UV Aspheric (Otufilcon A) 1-Day Silicone Soft (hydrophilic) Contact Lens (Daily Disposable) | Yung Sheng Optical Co., Ltd. |
How long does FDA review take for LPL?
The median FDA review time for LPL is 84 days, measured across the 486 most recent decisions with both a received date and a decision date.
Review time here is decision date minus date received, as published by FDA. It is elapsed calendar time, not FDA review days — the two differ whenever the agency stops the clock for an additional information request.
Source: openFDA device/510k · retrieved
Are there recalls in LPL?
openFDA lists 70 recall records against product code LPL. A recall record covers one firm's corrective action and may span many device lots.
Z-0326-2026Open, ClassifiedAlcon Research, LLC
Potential for a weak seal in some units resulting in compromise in sterility.
Z-2163-2025Open, ClassifiedJohnson & Johnson Vision Care, Inc.
Due to defects (bubbles/voids) identified during standard finished goods testing
Z-3313-2024Open, ClassifiedAlcon Research, LLC
Material with a quality issue was used in contact lens production, so contact lenses may not meet quality and/or performance standards for the entirety of their labeled shelf life, and wearing these lenses may lead to temporary issues such as irritation, redness, or blurred vision.
Z-1282-2023Open, ClassifiedCooperVision, Inc.
The lenses manufactured in the affected lot were made with a misaligned axis resulting in lenses with the incorrect power.
Z-1014-2023Open, ClassifiedCooperVision, Inc.
Lenses may be of the incorrect power. A patient who uses an affected lens may experience poor visual acuity.
Showing the 5 most recently initiated of 70. Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Status is FDA's own wording; a terminated recall is a closed one, and the total spans the code's whole history, not just what is open today.
Source: openFDA device/recall · retrieved
How many adverse events are reported for LPL?
MAUDE holds 681 adverse-event reports naming product code LPL, 132 of them received in the last 12 months.
MAUDE reports are submitted by manufacturers, importers, user facilities and the public. They are unverified, and a report is not proof that the device caused the event.
Source: openFDA device/event · retrieved
Is adverse-event reporting in LPL unusual?
Every month with enough history behind it falls inside LPL's own expected range. Nothing here is unusual for this code.
| Month | Reports | Expected | Verdict |
|---|---|---|---|
| 6 | Insufficient history | No expected range — too little history | |
| 6 | Insufficient history | No expected range — too little history | |
| 13 | Insufficient history | No expected range — too little history | |
| 16 | Insufficient history | No expected range — too little history | |
| 4 | Insufficient history | No expected range — too little history | |
| 19 | Insufficient history | No expected range — too little history | |
| 9 | Insufficient history | No expected range — too little history | |
| 22 | Insufficient history | No expected range — too little history | |
| 18 | Insufficient history | No expected range — too little history | |
| 11 | Insufficient history | No expected range — too little history | |
| 17 | Insufficient history | No expected range — too little history | |
| 27 | Insufficient history | No expected range — too little history | |
| 20 | Insufficient history | No expected range — too little history | |
| 23 | Insufficient history | No expected range — too little history | |
| 29 | Insufficient history | No expected range — too little history | |
| 31 | Insufficient history | No expected range — too little history | |
| 22 | Insufficient history | No expected range — too little history | |
| 39 | Insufficient history | No expected range — too little history | |
| 40 | Insufficient history | No expected range — too little history | |
| 19 | Insufficient history | No expected range — too little history | |
| 19 | Insufficient history | No expected range — too little history | |
| 14 | 7–39 | Within expected (7–39) | |
| 14 | 5–31 | Within expected (5–31) | |
| 10 | 4–33 | Within expected (4–33) | |
| 18 | 0–33 | Within expected (0–33) | |
| 29 | 0–32 | Within expected (0–32) | |
| 19 | 4–38 | Within expected (4–38) | |
| 22 | 6–57 | Within expected (6–57) | |
| 12 | 2–41 | Within expected (2–41) | |
| 19 | 0–42 | Within expected (0–42) | |
| 19 | 2–37 | Within expected (2–37) | |
| 16 | 6–29 | Within expected (6–29) | |
| 18 | 6–31 | Within expected (6–31) | |
| 21 | 6–36 | Within expected (6–36) | |
| 14 | 5–30 | Within expected (5–30) | |
| 20 | 4–32 | Within expected (4–32) |
21 months do not have a full, unbroken year of history before them, so no expected range is shown for those. Insufficient history is reported as insufficient rather than as zero: an empty baseline would turn a gap in our data into a spike. Method: ewma_alpha_0.3_sd_2 corpus_adjusted. Counts are divided by the corpus-wide volume for that month before comparison, so a rise across all of MAUDE is not reported as a rise in LPL.
What are the predicate devices in LPL?
FDA publishes no machine-readable predicate field, so no predicate chain is recorded for this code yet.
A predicate chain matters because a device inherits the safety history of what it was compared to. FDA publishes the chain only inside each 510(k) summary PDF, never as data — so where we have edges, they are read from those documents, and where we do not, we say so instead of showing an empty list.
Who files 510(k)s in LPL?
Across the 486 most recent decisions, these applicants filed most often in LPL.
| Applicant | Recent clearances |
|---|---|
| CooperVision, Inc. | 37 |
| Alcon Laboratories, Inc. | 22 |
| Ciba Vision Corporation | 14 |
| Pegavision Corporation | 14 |
| Unilens Corp., USA | 14 |
Applicant names above are exactly as FDA published them, so one company can appear under several spellings.
The same makers, after name resolution
One company in LPL files under more than one spelling. Resolving them to one identity — across all six datasets, not just this one — is what makes a joined count possible at all.
| Company | Clearances | FDA spellings merged |
|---|---|---|
| Bausch and Lomb, Incorporated | 20 | 4 |
Merges are measured against a hand-labelled sample and held above 98% precision; pairs the matcher is unsure of are queued for a person rather than merged. See DeviceSignal.
Source: openFDA device/510k · retrieved
Watch LPL
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Data on this page comes from FDA's public openFDA API and is US public domain (CC0). DeviceSignal is an independent commercial service and is not affiliated with the U.S. Food and Drug Administration. Information only, not regulatory advice. Verify anything you rely on against open.fda.gov.