Data / Medical devices / United States / Alcon Research, LLC
Alcon Research, LLC: FDA-registered device maker in Duluth, GA, United States, 21 510(k) clearances and 2 PMA approvals
Alcon Research, LLC is registered with the FDA (registration 1053053) in Duluth, GA, United States. It lists 5 device types. The FDA files 21 510(k) clearances and 2 PMA approvals under its listings, the newest dated November 16, 2023. 15 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1053053
- Address
- 11440 Johns Creek Parkway, Duluth, GA, United States, 30097
- Owner or operator
- Alcon Laboratories, Inc. (1610287)
- Roles
- Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- August 13, 2013
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Frame, Trial, Ophthalmic | HPA | 1 | Specification developer | accessdata.fda.gov |
| Lens, Contact, (Disposable) | MVN | 2 | Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Lenses, Soft Contact, Daily Wear | LPL | 2 | Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Lenses, Soft Contact, Extended Wear | LPM | 3 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Set, Lens, Trial, Ophthalmic | HPC | 1 | Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| November 16, 2023 | K232921 | DAILIES TOTAL1®; DAILIES TOTAL1® Toric; DAILIES TOTAL1® Multifocal; DAILIES TOTAL1® Multifocal Toric | LPL | Substantially Equivalent | Alcon Laboratories, Inc. | accessdata.fda.gov |
| September 15, 2022 | K222500 | AIR OPTIX COLORS | LPL | Substantially Equivalent | Alcon Laboratories, Inc. | accessdata.fda.gov |
| December 28, 2021 | K212806 | Alcon (serafilcon A) soft contact lenses for daily wear | LPL | Substantially Equivalent | Alcon Laboratories, Inc. | accessdata.fda.gov |
| April 12, 2021 | K210436 | Total30, Total30 for Astigmatism, Total30 Multifocal, Total30 Multifocal Toric, Total30 Asphere | LPL | Substantially Equivalent | Alcon Laboratories, Inc. | accessdata.fda.gov |
| September 22, 2020 | K202448 | DAILIES AquaComfort Plus (DACP) / DACP FreshTech / DACP Toric / DACP Multifocal | MVN | Substantially Equivalent | Alcon Laboratories, Inc. | accessdata.fda.gov |
| August 21, 2020 | K202036 | Focus DAILIES / Focus DAILIES Toric / Focus DAILIES Progressives, DAILIES AquaComfort Plus (DACP) / DACP FreshTech / DACP Toric / DACP Multifocal | MVN | Substantially Equivalent | Alcon Laboratories, Inc. | accessdata.fda.gov |
| February 6, 2019 | K190045 | DAILIES Colors, DAILIES Colors Toric, DAILIES Colors Progressives | LPL | Substantially Equivalent | Alcon Laboratories, Inc. | accessdata.fda.gov |
| January 18, 2019 | K182782 | DAILIES TOTAL1, DAILIES TOTAL1 Asphere, DAILIES TOTAL1 for ASTIGMATISM, DAILIES TOTAL1 Multifocal, DAILIES TOTAL1 Multifocal Toric | LPL | Substantially Equivalent | Alcon Laboratories, Inc. | accessdata.fda.gov |
| December 11, 2018 | K182902 | Precision1 | LPL | Substantially Equivalent | Alcon Laboratories, Inc. | accessdata.fda.gov |
| August 3, 2018 | K181796 | FreshLook Handling Tint, FreshLook Colors, FreshLook ColorBlends, FreshLook Dimensions | LPL | Substantially Equivalent | Alcon Laboratories, Inc. | accessdata.fda.gov |
| October 25, 2017 | K172600 | AIR OPTIX COLORS, AIR OPTIX COLORS Toric, AIR OPTIX COLORS Multifocal | LPL | Substantially Equivalent | Alcon Laboratories, Inc. | accessdata.fda.gov |
| November 30, 2016 | K161391 | DAILIES AquaComfort Plus, DAILIES AquaComfort Plus Toric, DACP Multifocal, Focus DAILIES, Focus DAILIES Toric, Focus DAILIES Progressives | LPL | Substantially Equivalent | Alcon Laboratories, Inc. | accessdata.fda.gov |
| January 20, 2016 | K153643 | Focus DAILIES, Focus DAILIES Toric, Focus DAILIES Progressives | LPL | Substantially Equivalent | Alcon Laboratories, Inc. | accessdata.fda.gov |
| January 20, 2016 | K153642 | DAILIES AquaComfort Plus, DAILIES AquaComfort Plus Toric, DAILIES AquaComfort Plus Multifocal | LPL | Substantially Equivalent | Alcon Laboratories, Inc. | accessdata.fda.gov |
| January 29, 2014 | K133176 | AIR OPTIX COLORS, AIR OPTIX COLORS TORIC, AIR OPTIX COLORS MULTIFOCAL | LPL | Substantially Equivalent | Ciba Vision Corporation | accessdata.fda.gov |
| February 21, 2013 | K123994 | DAILIES AQUACOMFORT PLUS, DAILIES AQUACOMFORT PLUS TORIC, DAILIES AQUACOMFORT PLUS MULTIFOCAL | LPL | Substantially Equivalent | Ciba Vision Corporation | accessdata.fda.gov |
| March 30, 2012 | K113168 | DAILIES TOTAL DALIES TOTAL FOR ASTIGMATISM DAILIES TOTAL MULTIFOCAL DAILIES TOTAL MULTIFOCAL TORIC | LPL | Substantially Equivalent | Ciba Vision Corporation | accessdata.fda.gov |
| January 24, 2008 | K072777 | CIBA VISION (NELFILCON A) ONE-DAY SOFT CONTACT LENSES | LPL | Substantially Equivalent | Ciba Vision Corporation | accessdata.fda.gov |
| May 27, 2005 | K050065 | FOCUS DAILIES, FOCUS DAILIES TORIC AND FOCUS DAILIES PROGRESSIVES | MVN | Substantially Equivalent | Ciba Vision Corporation | accessdata.fda.gov |
| March 28, 2005 | K050213 | FRESHLOOK ONE-DAY COLOR CONTACT LENS | MVN | Substantially Equivalent | Ciba Vision Corporation | accessdata.fda.gov |
| November 27, 1996 | K963487 | DAILIES (NELFILCON A) ONE-DAY SOFT CONTACT LENS | LPL | Substantially Equivalent | Ciba Vision Corporation | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| April 25, 2023 | P220007 | Precision7; Precision7 for Astigmatism; Precision7 Multifocal; Precision7 Multifocal Toric (serafilcon A) Soft Conta | LPM | 7 | March 11, 2026 | accessdata.fda.gov |
| October 11, 2001 | P010019 | FOCUS NIGHT AND DAY (LOTRAFILCON A) SOFT CONTACT LENSES | LPM | 83 | May 29, 2026 | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| April 27, 2010 | 55570 | Not yet classified | Terminated | 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. | The lenses inside the package do not match the prescription information for power labeled on the primary package. | accessdata.fda.gov |
| April 30, 2007 | 37854 | Not yet classified | Terminated | CIBASoft Visitint Soft Contact Lenses, SKU #749591001385, Power -6.50, Diameter 13.8, Base Curve, 8.9, Expiration 2011-10. | Base curve of the lenses do not meet specification. | accessdata.fda.gov |
| January 11, 2007 | 37113 | Not yet classified | Terminated | 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). | Reduced Ion Permeability | accessdata.fda.gov |
| September 13, 2006 | 36382 | Not yet classified | Terminated | CSI Daily Wear, soft (hydrophilic) contact lenses | Out of specification lens curve | accessdata.fda.gov |
| July 25, 2006 | 35990 | Not yet classified | Terminated | Focus * DAILIES * Toric * One-Day Contact Lenses * CIBA Vision | Misbranding; Lenses (-0.75) are labeled with the incorrect power of (-1.50). | accessdata.fda.gov |
| November 2, 2005 | 33960 | Not yet classified | Terminated | 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 Corporation, Duluth, GA 30097 | Lack of assurance of sterility at the time of manufacture. | accessdata.fda.gov |
| April 21, 2005 | 31864 | Not yet classified | Terminated | 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 of lenses. | The actual power of the lenses may be different from what is indicated on the package labeling. | accessdata.fda.gov |
| September 27, 2004 | 30159 | Not yet classified | Terminated | 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, Manufactured for: CIBA V | Stability tests at 24 months revealed failing results for disinfection efficacy. | accessdata.fda.gov |
| March 11, 2004 | 28542 | Not yet classified | Terminated | 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, USA, Made in USA. Pr | The lens inside the package does not match the prescription information labeled on the primary package. | accessdata.fda.gov |
| August 13, 2003 | 26932 | Not yet classified | Terminated | Quick Care Starting Solution. The product is used for cleaning and disinfection of soft (hydrophilic) contact lenses. | Investigation has determined that the concentration of the isopropyl alcohol (IPA) decreased over time and may fall below specifications prior to reaching the expiration date. | accessdata.fda.gov |
| May 6, 2003 | 26221 | Not yet classified | Terminated | 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. USA. The product is | Lenses may be labeled with the incorrect axis. | accessdata.fda.gov |
| March 17, 2003 | 25796 | Not yet classified | Terminated | Glitter Eyes (tefilcon), daily wear soft (hydrophilic) contact lenses packed as single units or kits in mulitple glass vials. | The lens may partially 'delaminate' in the area of one of the encapsulated cosmetic prints. | accessdata.fda.gov |
| January 17, 2003 | 26077 | Not yet classified | Terminated | 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. The product was distr | FreshLook 'Colors' contact lenses were incorrectly packaged into a FreshLook 'Colorblends' carton. | accessdata.fda.gov |
| December 16, 2002 | 25221 | Not yet classified | Terminated | 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, Sterile. | Mislabeling | accessdata.fda.gov |
| November 12, 2002 | 25101 | Not yet classified | Terminated | 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. | Lenses were labeled with the wrong prescription. | accessdata.fda.gov |
Compare with other makers
- All makers of Lens, Contact, (Disposable)
- All makers of Lenses, Soft Contact, Daily Wear
- All makers of Frame, Trial, Ophthalmic
- All makers of Lenses, Soft Contact, Extended Wear
- All makers of Set, Lens, Trial, Ophthalmic
Updated March 11, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.