Company ยท US
Ciba Vision Corporation
FDA 510(k) clearances and medical device recalls filed under this name, 1994 to 2014. Name variants (Inc, Corp, punctuation) are merged.
44510(k) clearances (0 in 12 months)
20recalls (0 in 12 months)
6recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| LPL | Lenses, Soft Contact, Daily Wear | 23 |
| LPN | Accessories, Soft Lens Products | 16 |
| LPM | Lenses, Soft Contact, Extended Wear | 8 |
| MRC | Products, Contact Lens Care, Rigid Gas Permeable | 6 |
| MVN | Lens, Contact, (Disposable) | 6 |
| HNO | Keratome, Ac-Powered | 2 |
| LRX | Case, Contact Lens | 2 |
| LYL | Accessories, Solution, Ultrasonic Cleaners For Lenses | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 29, 2014 | K133176 | AIR OPTIX COLORS, AIR OPTIX COLORS TORIC, AIR OPTIX COLORS MULTIFOCAL Ciba Vision Corporation | LPL |
| Feb 21, 2013 | K123994 | DAILIES AQUACOMFORT PLUS, DAILIES AQUACOMFORT PLUS TORIC, DAILIES AQUACOMFORT PLUS MULTIFOCAL Ciba Vision Corporation | LPL |
| Mar 30, 2012 | K113168 | DAILIES TOTAL DALIES TOTAL FOR ASTIGMATISM DAILIES TOTAL MULTIFOCAL DAILIES TOTAL MULTIFOCAL TORIC Ciba Vision Corporation | LPL |
| Apr 14, 2009 | K083216 | CIBA VISION (NELFILCON A) ONE-DAY SOFT CONTACT LENSES Ciba Vision Corporation | LPL |
| Feb 28, 2008 | K073459 | CIBA VISION (LOTRAFILCON B) SOFT CONTACT LENSES Ciba Vision Corporation | LPL |
| Jan 24, 2008 | K072777 | CIBA VISION (NELFILCON A) ONE-DAY SOFT CONTACT LENSES Ciba Vision Corporation | LPL |
| Nov 14, 2006 | K062262 | CIBA VISION (SIFILCON A) SPHERICAL, TORIC, MULTIFOCAL AND MULTIFOCAL TORIC DESIGNS Ciba Vision Corporation | LPL |
| Sep 9, 2005 | K041820 | SOLO-CARE AQUA ANTIMICROBIAL LENS CASE Ciba Vision Corporation | LRX |
| Aug 10, 2005 | K050250 | AQUIFY MULTIPURPOSE SOLUTION Ciba Vision Corporation | LPN |
| May 27, 2005 | K050065 | FOCUS DAILIES, FOCUS DAILIES TORIC AND FOCUS DAILIES PROGRESSIVES Ciba Vision Corporation | MVN |
| Mar 28, 2005 | K050213 | FRESHLOOK ONE-DAY COLOR CONTACT LENS Ciba Vision Corporation | MVN |
| Nov 3, 2004 | K042176 | AQUIFY LENS COMFORT DROPS Ciba Vision Corporation | LPN |
| Oct 28, 2004 | K031753 | KARATS MULTIPURPOSE SOLUTION Ciba Vision Corporation | LPN |
| Mar 12, 2004 | K033919 | CIBA VISION (LOTRAFILCON B) SPHERICAL, TORIC, MULTIFOCAL AND TORIC MULTIFOCAL DESIGNS Ciba Vision Corporation | LPL |
| Feb 2, 2004 | K033608 | AQUIFY MULTI-PURPOSE SOLUTION Ciba Vision Corporation | LPN |
| Dec 15, 2003 | K033701 | FOCUS DAILIES, FOCUS DAILIES TORIC AND FOCUS DAILIES PROGRESSIVES ONE-DAY SOFT CONTACT LENSES Ciba Vision Corporation | MVN |
| Oct 20, 2003 | K032978 | MODIFICATION TO CIBA VISION CENTURION SES SPIKERATOME Ciba Vision Corporation | HNO |
| Sep 12, 2003 | K030522 | AOSEPT CLEAR CARE CLEANING AND DISINFECTING SOLUTION Ciba Vision Corporation | LPN |
| Aug 21, 2003 | K031735 | CENTURION SES EPIKERATOME Ciba Vision Corporation | HNO |
| Aug 14, 2003 | K031957 | MODIFICATION TO KARATS MULTI-PURPOSE SOLUTION Ciba Vision Corporation | LPN |
| Jun 27, 2003 | K031522 | SOLO-CARE PLUS MULTIPURPOSE SOLUTION Ciba Vision Corporation | LPN |
| Jun 27, 2003 | K031521 | AOSEPT CLEAR CARE CLEANING AND DISINFECTING SOLUTION Ciba Vision Corporation | LPN |
| Feb 28, 2003 | K023455 | AOSEPT CLEAR CARE CLEANING AND DISINFECTING SOLUTION Ciba Vision Corporation | MRC |
| Dec 10, 2002 | K023732 | CIBASOFT PROGRESSIVE TORIC (TEFILCON) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR Ciba Vision Corporation | LPL |
| Nov 19, 2002 | K022687 | AOSEPT CLEAR CARE CLEANING AND DISINFECTING SOLUTION Ciba Vision Corporation | LYL |
| Oct 28, 2002 | K021635 | KARATS MULTIPURPOSE SOLUTION Ciba Vision Corporation | LPN |
| Apr 9, 2002 | K020139 | FOCUS EXCELENS (LOTRAFILCON B) SPHERICAL, TORIC AND MULTIFOCAL DESIGN Ciba Vision Corporation | LPL |
| Apr 3, 2002 | K013204 | AQUIFY LENS COMFORT DROPS Ciba Vision Corporation | MRC |
| Dec 26, 2001 | K012731 | SOLO-CARE PLUS MULTIPURPOSE SOLUTION Ciba Vision Corporation | LPN |
| Dec 20, 2001 | K013512 | AOSEPT CLEAR CARE CLEANING AND DISINFECTING SOLUTION Ciba Vision Corporation | LPN |
| Mar 26, 2001 | K003345 | AOSEPT PLUS CLEANING AND DISINFECTING SOLUTION Ciba Vision Corporation | LPN |
| Mar 23, 2001 | K010636 | FOCUS DAILIES (NELFILCON A) ONE-DAY SOFT CONTACT LENSES, FOCUS DAILIES PROGRESSIVES (NELFILCON A) ONE-DAY SOFT CONTACT Ciba Vision Corporation | MVN |
| Mar 8, 2001 | K003826 | FOCUS DAILIES PROGRESSIVES Ciba Vision Corporation | MVN |
| Dec 13, 2000 | K003071 | GLITTER EYES (TEFILCON) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR Ciba Vision Corporation | LPL |
| May 15, 2000 | K000607 | SOLO-CARE BRAND HARD SOLUTION Ciba Vision Corporation | MRC |
| Jan 5, 2000 | K993949 | SOLO-CARE BRAND HARD SOLUTION Ciba Vision Corporation | MRC |
| Jul 16, 1999 | K991403 | SOLO-CARE BRAND MULTI-PURPOSE SOLUTION Ciba Vision Corporation | LPN |
| Jan 25, 1999 | K984273 | FOCUS DAILIES VISITINT (NELFILCON A) ONE-DAY CONTACT LENS Ciba Vision Corporation | MVN |
| Nov 25, 1998 | K983291 | SOLO-CARE BRAND MULTI-PURPOSE SOLUTION Ciba Vision Corporation | MRC |
| Nov 17, 1998 | K982168 | SOLO-CARE BRAND MULTI-PURPOSE SOLUTION Ciba Vision Corporation | LPN |
| May 9, 1997 | K970746 | SEE3 (LOTRAFILCON A) SOFT CONTACT LENS Ciba Vision Corporation | LPL |
| Nov 27, 1996 | K963487 | DAILIES (NELFILCON A) ONE-DAY SOFT CONTACT LENS Ciba Vision Corporation | LPL |
| Aug 4, 1994 | K943183 | CIBA VISION(R) CONTACT LENS CASE Ciba Vision Corporation | LRX |
| Jun 9, 1994 | K941484 | DAILY WEAR SOFT CONTACT LENSES Ciba Vision Corporation | LPL |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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 |
| May 9, 2007 | Ciba Vision Corporation CIBASoft Visitint Soft Contact Lenses, SKU #749591001385, Power -6.50, Diameter 13.8, Base Curve, 8.9, Expiration 2011-10. Terminated |
LPL | 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 |
| Nov 4, 2006 | Ciba Vision Corporation CSI Toric, soft (hydrophilic) contact lenses Terminated |
LPL | None listed |
| Nov 4, 2006 | Ciba Vision Corporation CSI Flexible Wear, soft (hydrophilic) contact lenses Terminated |
LPL | None listed |
| Nov 4, 2006 | Ciba Vision Corporation CSI Daily Wear, soft (hydrophilic) contact lenses Terminated |
LPL | None listed |
| Aug 16, 2006 | Ciba Vision Corporation Focus * DAILIES * Toric * One-Day Contact Lenses * CIBA Vision Terminated |
LPL | K050065 |
| Nov 23, 2005 | Ciba Vision Corporation AQuify Drops, Long Lasting Comfort Drops * Relieves Dryness * For Soft and RGP Contact Lenses * 1/3 fl. Oz. (10mL) * Sterile * CIBA Vision Corp. Made In Canada Manufactured for: CIBA Vision Corporatio Terminated |
MRC | K013204 |
| Apr 21, 2005 | Ciba Vision Corporation Fresh Look * Radiance * Moonlight, (phemfilcon) Contact Lenses * -2.75 median, Median Dia:14.5 * Rx only * Ciba Vision, Duluth, GA. The product has been distributed in twin packs containing six pairs Terminated |
LPL | None listed |
| Oct 21, 2004 | Ciba Vision Corporation SOLO-care Plus with Aqualube, Multi-purpose solution*** AquaSoft (Private label), Multi-purpose solution***Sterile***For soft lenses, CIBA Vision Corporation, Made in Canada, Assembled in Canada, Man Terminated |
LPN | K031522 |
| 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 |
| Sep 13, 2003 | Ciba Vision Corporation Quick Care Starting Solution. The product is used for cleaning and disinfection of soft (hydrophilic) contact lenses. Terminated |
LPN | None listed |
| May 15, 2003 | Ciba Vision Corporation Focus DAILIES Toric (nelfilcon), One-Day Contact Lenses, Daily Disposable (hydrophilic) soft contact lens, Rx only, Sterile, -1.50, -1.75 x 090, BC 8.6, DIA 14.2, CIBA Vision Corp., Duluth, GA 30097. Terminated |
LPL | K963487 |
| 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 |
| Apr 1, 2003 | Ciba Vision Corporation Glitter Eyes (tefilcon), daily wear soft (hydrophilic) contact lenses packed as single units or kits in mulitple glass vials. Terminated |
LPL | K003071 |
| 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 18, 2002 | Ciba Vision Corporation Blue-Vis, CIBASOFT VISITINT, daily wear contact lens. Lot 1170119, Expiration 2007/10, BC 8.9, DIA 13.8, SPH -1.50, CIBA Vision, Corp, Duluth, GA 30097, Made in USA. Terminated |
LPL | None listed |