ClearanceBrief
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)
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Top companies in LPM

Company510(k)sRecalls
CooperVision Inc.09
Ciba Vision Corporation08
Intertrade Imports Inc.02
Allied Vision Group Inc01
Bausch & Lomb Inc01
Cooper Vision Caribbean Corp.01
Johnson & Johnson Vision Care, Inc.01
Kim's Trading Inc01
Lens.com01
Vistakon01
DateFirm and productCodeLinked 510(k)
Jul 23, 2025CooperVision, Inc.
Biofinity Toric Multifocal Contact Lens
Open, Classified
LPMNone listed
Jul 23, 2025CooperVision, Inc.
Biofinity XR Toric Contact Lens
Open, Classified
LPMNone listed
Sep 30, 2024CooperVision, 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
LPMNone listed
Sep 30, 2024CooperVision, 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
LPMNone listed
Mar 1, 2023CooperVision, Inc.
Biofinity XR Toric Single Diagnostic lens- Soft (hydrophilic) Contact Lens (extended wear)
Open, Classified
LPMNone listed
Mar 1, 2023CooperVision, Inc.
Biofinity XR Toric 6-pack- Soft (hydrophilic) Contact Lens (extended wear)
Open, Classified
LPMNone listed
Jan 27, 2020CooperVision Inc.
Coopervision Vertex Toric /2 Clear Toric- Power +2.25 -0.75/120 Soft (hydrophilic) Contact Lens (extended wear)
Terminated
LPMNone listed
Jan 27, 2020CooperVision Inc.
Coopervision Vertex Toric /2 Clear Toric- Power -2.50 -0.75 /90 Soft (hydrophilic) Contact Lens (extended wear)
Terminated
LPMNone listed
Aug 14, 2018Lens.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
LPMNone listed
Aug 1, 2018Allied 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
LPMNone listed
Oct 19, 2017Johnson & Johnson Vision Care, Inc.
ACUVUE OASYS Brand Contact Lenses with HYDRACLEAR PLUS
Terminated
LPMK042275
Sep 1, 2017CooperVision 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
LPMK052560
Jan 12, 2015Intertrade 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
LPMNone listed
Jan 12, 2015Intertrade 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
LPMNone listed
Dec 15, 2014Cooper Vision Caribbean Corp.
Soft Contact Lens
Terminated
LPMNone listed
Sep 21, 2010Vistakon
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
LPMNone listed
Jun 4, 2010Kim'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
LPMNone listed
May 27, 2010Ciba 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
LPMNone listed
Feb 15, 2007Ciba 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
LPMK033919
Jul 20, 2004Ciba 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
LPMNone listed
Jul 20, 2004Ciba 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
LPMNone listed
Jul 20, 2004Ciba 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
LPMNone listed
Jul 20, 2004Ciba 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
LPMNone listed
May 1, 2003Ciba 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
LPMNone listed
Dec 31, 2002Ciba 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
LPMNone listed
Dec 19, 2002Bausch & 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
LPMNone listed

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