LPNFDA Class 2 · 21 CFR 886.5928
Accessories, Soft Lens Products
Device family · Ophthalmic
Automated profile from regulatory + adverse-event registries · AI-reviewed · expert clinical sign-off in progress — not yet independently verified.
FDA clearances
1,150
Manufacturers
40
Flagged signals
24
Adverse-event reports
4,782
Code matrix
| FDA product code | LPN |
| Device class | Class 2 |
| Regulation | 21 CFR 886.5928 |
| GMDN | — (crosswalk pending) |
| Implantable | No |
| Life-sustaining | No |
Adverse-event signals
Public · always freeMAUDE disproportionality (PRR), flagged where PRR ≥ 2, χ² ≥ 4, count ≥ 3.
| Event type | Year | Reports | PRR | χ² |
|---|---|---|---|---|
| Other | 2010 | 4 | 241.8 | 735 |
| Other | 2008 | 3 | 181.4 | 373 |
| 2018 | 3 | 177.2 | 363 | |
| Other | 2012 | 10 | 147.8 | 1,317 |
| Other | 2014 | 14 | 90.4 | 1,151 |
| Other | 2008 | 18 | 68.0 | 1,124 |
| Other | 2011 | 4 | 59.1 | 174 |
| Other | 2015 | 9 | 43.7 | 334 |
| Other | 2016 | 11 | 41.6 | 396 |
| Other | 2010 | 11 | 41.6 | 396 |
| Other | 2012 | 6 | 38.7 | 185 |
| Other | 2016 | 7 | 34.0 | 193 |
| Other | 2012 | 5 | 32.3 | 122 |
| Other | 2013 | 5 | 32.3 | 122 |
| Other | 2013 | 12 | 27.1 | 276 |
| Other | 2010 | 4 | 25.8 | 72 |
| Other | 2014 | 4 | 25.8 | 72 |
| Other | 2015 | 4 | 25.8 | 72 |
| Other | 2013 | 4 | 25.8 | 72 |
| Other | 2012 | 11 | 24.8 | 228 |
| Other | 2015 | 6 | 22.7 | 104 |
| Other | 2014 | 3 | 14.6 | 26 |
| Other | 2016 | 3 | 11.3 | 19 |
| Other | 2012 | 3 | 6.8 | 10 |
Device-level recall linkage pending an FDA-recalls product-code re-ingest. Class 2 family · 4,782 total adverse-event reports.
Manufacturer landscape
| Manufacturer | Clearances | Latest | Concern |
|---|---|---|---|
| Advanced Medical Optics, Inc. | 398 | 2005 | — |
| Alcon Laboratories | 247 | 1999 | — |
| Bausch & Lomb, Inc. | 92 | 2012 | — |
| Paco Pharmaceutical Services, Inc. | 46 | 1997 | — |
| Ciba Vision Care | 35 | 1995 | — |
| Ciba Vision Corporation | 32 | 2005 | — |
| Polymer Technology Corp. | 31 | 1998 | — |
| Blairex Laboratories, Inc. | 28 | 1994 | — |
| Wesley Jessen Corp. | 24 | 1994 | — |
| Abbott Medical Optics, Inc. | 23 | 2010 | — |
| Optopics Laboratories Corp. | 13 | 1996 | — |
| Marlin Industries | 12 | 1989 | — |
| Allergan, Inc. | 12 | 2019 | — |
| ATRION MEDICAL PRODUCTS, INC. | 11 | 1988 | — |
| Applied Laboratories, Inc. | 11 | 1994 | — |
| Automatic Liquid Packaging, Inc. | 9 | 1998 | — |
| Stericon, Inc. | 8 | 1990 | — |
| Amcon, Inc. | 8 | 1988 | — |
| Trp Company | 8 | 1997 | — |
| Eaton Medical Corp. | 8 | 1988 | — |
| Lobob Laboratories, Inc. | 7 | 1999 | — |
| Dow Corning Corp. Healthcare Industries Materials | 6 | 1991 | — |
| Steridyne Laboratories, Inc. | 6 | 1994 | — |
| Horizon Pharmacal, Inc. | 5 | 1985 | — |
| Bausch & Lomb, Incorporated | 5 | 2022 | — |
Concern score lights up where a maker maps to a scored entity (depth fast-follow).
Recent FDA clearances
Bausch + Lomb Preservative Free Lubricating and Rewetting Drops · Bausch & Lomb, Incorporated510(k) · 2022-12-06
Aqua Naina Plus Sterile Saline Solution · Chemtex USA, Inc.510(k) · 2022-10-12
ABT12 multi-purpose solution · Bausch & Lomb, Incorporated510(k) · 2021-05-28
OTE MPS 045 Multi-purpose Lens Care Solution · Ote North America, LLC510(k) · 2021-05-26
Aqua Naina Sterile Saline Solution · Chemtex USA, Inc.510(k) · 2020-05-26
PuriLens Plus Preservative Free Saline · The Lifestyle Company, Inc.510(k) · 2020-05-15
Menicon 3% Hydrogen Peroxide Cleaning and Disinfecting Solution · Menicon Co, Ltd.510(k) · 2020-03-02
REFRESH RELIEVA For CONTACTS · Allergan, Inc.510(k) · 2019-08-08
AOCup Lens Case with AODisc · Alcon Laboratories, Inc.510(k) · 2019-07-31
Bausch + Lomb Sensitive Eyes Plus Saline Solution · Bausch & Lomb, Incorporated510(k) · 2017-04-11
NNR06 Multi-Purpose Solution · Bausch & Lomb, Incorporated510(k) · 2016-11-25
Clear Care Cleaning & Disinfecting Solution, AOCup Lens Case with AODisc · Alcon Laboratories, Inc.510(k) · 2016-10-19
LensGiene Sterile Saline Solution · Optics Laboratory, Inc.510(k) · 2016-08-11
Menicon Saline Rinse Solution · Menicon Co, Ltd.510(k) · 2015-08-28
CLEAR CARE PLUS CLEANING & DISINFECTIONG SOLUTION WITH HYDRAGLYDE · Alcon Laboratories, Inc.510(k) · 2015-01-26
BAUSCH + LOMB PEROXICLEAR 3% HYDROGEN PEROXIDE CLEANING & DISINFECTING SOLUTION · Bausch & Lomb, Incorporated510(k) · 2013-09-09
SAUFLON MULTIPURPOSE SOLUTION · Sauflon Pharmaceuticals, Ltd.510(k) · 2013-05-15
OCD04 3% HYDROGEN PEROXIDE CLEANING AND DISINFECTING SOULTION · Bausch & Lomb, Inc.510(k) · 2012-04-30
EZS05 CLEANING AND DISINFECTING SOLUTION, BAUSCH + LOMB EZS05 CLEANING AND DISINFECTING SOLUTION · Bausch & Lomb, Inc.510(k) · 2012-01-24
EYE-CEPT STERILE SALINE SOLUTION · Optics Laboratory, Inc.510(k) · 2011-11-01
ALCON MULTI-PIRPOSE DISINFECTING SOLUTION · Alcon Research, Ltd.510(k) · 2011-05-10
STERILE SALINE SOLUTION · Cachet Pharmaceuticals Pvt. , Ltd.510(k) · 2011-01-19
AMO BRAND MULTI-PURPOSE DISINFECTING SOLUTION · Abbott Medical Optics, Inc.510(k) · 2010-09-15
STERILE SALINE SOLUTION · Cachet Pharmaceuticals Pvt. , Ltd.510(k) · 2010-09-10
REFRESH OPTIVE LENS COMFORT REWETTING DROPS · Allergan, Inc.510(k) · 2009-07-09
Sources: FDA 510(k)/PMA · openFDA MAUDE · FDA device classification · MedevIQ manufacturer-canonical. Registry data, AI-reviewed; expert clinical sign-off in progress.