Panels › Ophthalmic › Product code LPM · Class 3
Lenses, Soft Contact, Extended Wear
Regulation 886.5925
0510(k)s in 12 months (0 all time)
0recalls in 12 months (26 all time)
3recalls that name a 510(k)
Top companies in LPM
| Company | 510(k)s | Recalls |
|---|---|---|
| CooperVision Inc. | 0 | 9 |
| Ciba Vision Corporation | 0 | 8 |
| Intertrade Imports Inc. | 0 | 2 |
| Allied Vision Group Inc | 0 | 1 |
| Bausch & Lomb Inc | 0 | 1 |
| Cooper Vision Caribbean Corp. | 0 | 1 |
| Johnson & Johnson Vision Care, Inc. | 0 | 1 |
| Kim's Trading Inc | 0 | 1 |
| Lens.com | 0 | 1 |
| Vistakon | 0 | 1 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 23, 2025 | CooperVision, Inc. Biofinity Toric Multifocal Contact Lens Open, Classified |
LPM | None listed |
| Jul 23, 2025 | CooperVision, Inc. Biofinity XR Toric Contact Lens Open, Classified |
LPM | None listed |
| Sep 30, 2024 | CooperVision, Inc. Biofinity Toric Multifocal Lenses - Soft Contact lenses Indicated for the correction of ametropia (myopia or hyperopia with astigmatism) with presbyopia in aphakic and non-aphakic persons. Open, Classified |
LPM | None listed |
| Sep 30, 2024 | CooperVision, Inc. BIOFINITY XR TORIC Lenses - Soft Contact lenses Indicated for the correction of ametropia (myopia or hyperopia with astigmatism) with presbyopia in aphakic and non-aphakic persons. Open, Classified |
LPM | None listed |
| Mar 1, 2023 | CooperVision, Inc. Biofinity XR Toric Single Diagnostic lens- Soft (hydrophilic) Contact Lens (extended wear) Open, Classified |
LPM | None listed |
| Mar 1, 2023 | CooperVision, Inc. Biofinity XR Toric 6-pack- Soft (hydrophilic) Contact Lens (extended wear) Open, Classified |
LPM | None listed |
| Jan 27, 2020 | CooperVision Inc. Coopervision Vertex Toric /2 Clear Toric-
Power +2.25 -0.75/120
Soft (hydrophilic) Contact Lens (extended wear) Terminated |
LPM | None listed |
| Jan 27, 2020 | CooperVision Inc. Coopervision Vertex Toric /2 Clear Toric-
Power -2.50 -0.75 /90
Soft (hydrophilic) Contact Lens (extended wear) Terminated |
LPM | None listed |
| Aug 14, 2018 | Lens.com Alcon Air Optix Night & Day Aqua (lotrafilcon A), breathable contact lenses, PWR - 1.50 BC 8.6 DIA 13.8, Rx, Sterile. The firm name on the label is Alcon Laboratories, Inc., Fort Worth, TX. Completed |
LPM | None listed |
| Aug 1, 2018 | Allied Vision Group Inc Alcon Air Optix Night & Day Aqua (lotrafilcon A), breathable contact lenses, PWR - 1.50 BC 8.6 DIA 13.8, Rx, Sterile. The firm name on the label is Alcon Laboratories, Inc., Fort Worth, TX. Completed |
LPM | None listed |
| Oct 19, 2017 | Johnson & Johnson Vision Care, Inc. ACUVUE OASYS Brand Contact Lenses with HYDRACLEAR PLUS Terminated |
LPM | K042275 |
| Sep 1, 2017 | CooperVision Inc. Biofinity XR Toric contact lenses 8.7/14.5 - 6PK
Biofinity XR Toric (comfilcon A) Soft (Hydrophilic) Contact Lenses are indicated for the correction of ametropia (myopia or hyperopia) with astigmati Terminated |
LPM | K052560 |
| Jan 12, 2015 | Intertrade Imports Inc. Labeled in part: I Color Complete / Crazy Lens, blister packing, 14.5mm,
(Additional colors include: #003 White out, #005 Yellow out, #020 Red out, #014 Black out, #070 Manson, #136 Lava, #009 Yello Terminated |
LPM | None listed |
| Jan 12, 2015 | Intertrade Imports Inc. Labeled in part: I Color Complete / Color Lens, blister packing, 14.5mm.
(Additional colors include: 1) Illusion style, Chestnut Brown, Violet and others and 2) 2 Tone style: like Misty Blue among oth Terminated |
LPM | None listed |
| Dec 15, 2014 | Cooper Vision Caribbean Corp. Soft Contact Lens Terminated |
LPM | None listed |
| Sep 21, 2010 | Vistakon Primary (inner) Package Label: ACUVUE OASYS BRAND CONTACT LENSES for ASTIGMATISM with HYDRACLEAR Plus (senofilcon A) Johnson & Johnson Vision Care, Inc. Rx Only, STERILE. Lot B006WBS1 -9.00D -1.25 C Terminated |
LPM | None listed |
| Jun 4, 2010 | Kim's Trading Inc Fancy i Color cosmetic lens, Contents: A pair of sterile soft color contact lens immersed in buffered isotonic saline solution, Size: B.C. 8.6mm DIA. 14.5mm. Dreamcon Co. LTD. Korea. Terminated |
LPM | None listed |
| May 27, 2010 | Ciba Vision Corporation AIR OPTIX (lotrafilcon B) for Astigmatism Soft Contact Lenses. CIBA Vision, Corp. Duluth, GA 30097.
Toric lenses approved for daily wear and extended wear up to 6 nights. Terminated |
LPM | None listed |
| Feb 15, 2007 | Ciba Vision Corporation OOptix (lotrafilcon B) Soft Contact Lenses, Rx only, Ciba Vision. The product is distributed in 3 packs (3 lenses per package) and 6 packs (6 lenses per package). Terminated |
LPM | K033919 |
| Jul 20, 2004 | Ciba Vision Corporation FreshLook Toric, Daily wear soft (hydrophilic) contact lens, BC: Median, DIA: 14.5, Sterile, SPH -1.50, CYL -0.75, AXIS 020, LOT ***, 2006-04, WJ, Wesley Jessen Corporation, 333 E. Howard Avenue, Des Terminated |
LPM | None listed |
| Jul 20, 2004 | Ciba Vision Corporation FreshLook Enhancers, Daily wear soft (hydrophilic) contact lens, BC: Median, DIA: 14.5, Sterile, SPH -0.75, LOT ***, 2008-06, WJ, Wesley Jessen Corporation, 333 E. Howard Avenue, Des Plaines, IL 6001 Terminated |
LPM | None listed |
| Jul 20, 2004 | Ciba Vision Corporation FreshLook Colors, Daily wear soft (hydrophilic) contact lens, BC: Median, DIA: 14.5, Rx Only, Sterile, SPH ***, LOT ***, 2006-11, CIBA VISION Corporation, A Novartis Company, Duluth, GA 30007, USA, M Terminated |
LPM | None listed |
| Jul 20, 2004 | Ciba Vision Corporation FreshLook ColorBlends, Daily wear soft (hydrophilic) contact lens, BC: Median, DIA: 14.5, Rx Only, Sterile, SPH -5.25, LOT ***, 2006-08, CIBA VISION Corporation, A Novartis Company, Duluth, GA 30007, Terminated |
LPM | None listed |
| May 1, 2003 | Ciba Vision Corporation FreshLook Colors (phemfilcon A), 7-day Extended wear soft (hydrophilic) contact lens, Violet, SPH -0.75, Lot 064429, 2006-11, BC: Median DIA: 14-5, Rx only, CIBA Vision Corp., Duluth, GA 30097, USA. T Terminated |
LPM | None listed |
| Dec 31, 2002 | Ciba Vision Corporation FreshLook, TORIC, for Astigmatism (phemfilcon A) Contact Lenses, BC Median, DIA 14.5, Lot 041599, 2007-01Wesley Jessen Corporation, 333 E. Howard Avenue, Des Plains, IL 60018, USA, Made in USA, Steril Terminated |
LPM | None listed |
| Dec 19, 2002 | Bausch & Lomb Inc OPTIMA FW (polymacon) Visibility Tinted Contact Lenses, labeled as -2.25D, 8.7 mm. Responsible firm on the label: Bausch & Lomb Inc., Rochester, NY 14692.
Each box contains six lenses. Terminated |
LPM | None listed |
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