Alcon Laboratories
Medical device manufacturer in Fort Worth, TX.
90510(k) clearances
23PMA approvals
12recalls
Device types
- LPL Lenses, Soft Contact, Daily Wear 22
- LPN Accessories, Soft Lens Products 15
- HQC Unit, Phacofragmentation 8
- OOE Ophthalmic Femtosecond Laser 5
- LRX Case, Contact Lens 4
- GEX Powered Laser Surgical Instrument 4
- KYB Lens, Guide, Intraocular 3
- MVN Lens, Contact, (Disposable) 2
- NCF Aberrometer, Ophthalmic 2
- HNR Forceps, Ophthalmic 2
- DQF Actuator, Syringe, Injector Type 1
- KDN System, Perfusion, Kidney 1
- MPA Endoilluminator 1
- HOZ Sponge, Ophthalmic 1
- GAP Suture, Nonabsorbable, Silk 1
- LRO General Surgery Tray 1
- HNF Scissors, Ophthalmic 1
- FZI Apparatus, Air Handling, Enclosure 1
- HLI Ophthalmoscope, Ac-Powered 1
- EPT Microscope, Surgical 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K254052 | DAILIES TOTAL1®; DAILIES TOTAL1® MultifocalLPL · Traditional | 02/13/2026SE |
| K252682 | LenSx Laser System (8065000944)OOE · Special | 09/24/2025SE |
| K243896 | LenSx Laser System (8065998162)OOE · Traditional | 04/28/2025SE |
| K243909 | Precision1; Precision1 for Astigmatism; Dailies Total1; Dailies Total1 for Astigmatism…LPL · Special | 01/13/2025SE |
| K242184 | Alcon 27GA Chandelier (8065000252); Alcon 27+ DS Wide Angle Endoilluminator…MPA · Traditional | 12/04/2024SE |
| K233876 | Unity VCS (8065000296); Unity CS (8065000297)HQC · Traditional | 06/21/2024SE |
| K233902 | Centurion Vision System (Active Sentry) (8065753057)HQC · Special | 01/10/2024SE |
| K233856 | Precision1; Precision1 for Astigmatism; TOTAL30; TOTAL30 for Astigmatism; TOTAL30…LPL · Special | 12/29/2023SE |
| K232921 | DAILIES TOTAL1®; DAILIES TOTAL1® Toric; DAILIES TOTAL1® Multifocal; DAILIES TOTAL1®…LPL · Traditional | 11/16/2023SE |
| K230785 | Precision1, Precision1 for AstigmatismLPL · Special | 04/20/2023SE |
| K222500 | Air Optix ColorsLPL · Special | 09/15/2022SE |
| K212806 | Alcon (serafilcon A) soft contact lenses for daily wearLPL · Traditional | 12/28/2021SE |
| K212039 | CLAREON MONARCH IV IOL Delivery SystemMSS · Traditional | 08/23/2021SE |
| K210436 | Total30, Total30 for Astigmatism, Total30 Multifocal, Total30 Multifocal Toric, Total30…LPL · Traditional | 04/12/2021SE |
| K202448 | DAILIES AquaComfort Plus (DACP) / DACP FreshTech / DACP Toric / DACP MultifocalMVN · Special | 09/22/2020SE |
| K202036 | Focus DAILIES / Focus DAILIES Toric / Focus DAILIES Progressives, DAILIES AquaComfort…MVN · Special | 08/21/2020SE |
| K191795 | AOCup Lens Case with AODiscLPN · Special | 07/31/2019SE |
| K190392 | WaveLight FS200 Patient InterfaceGEX · Special | 03/26/2019SE |
| K190045 | DAILIES Colors, DAILIES Colors Toric, DAILIES Colors ProgressivesLPL · Special | 02/06/2019SE |
| K182782 | DAILIES TOTAL1, DAILIES TOTAL1 Asphere, DAILIES TOTAL1 for ASTIGMATISM, DAILIES TOTAL1…LPL · Traditional | 01/18/2019SE |
| K182902 | Precision1LPL · Traditional | 12/11/2018SE |
| K181454 | DAILIES AquaComfort Plus, DAILIES AquaComfort Plus FreshTech, DAILIES AquaComfort Plus…LPL · Traditional | 11/21/2018SE |
| K181796 | FreshLook Handling Tint, FreshLook Colors, FreshLook ColorBlends, FreshLook DimensionsLPL · Special | 08/03/2018SE |
| K180669 | Focus DAILIES / Focus DAILIES Toric / Focus DAILIES Progressives, DAILIES AquaComfort…LPL · Traditional | 04/27/2018SE |
| K180398 | Focus DAILIES / Focus DAILIES Toric / Focus DAILIES Progressives, DAILIES AquaComfort…LPL · Traditional | 04/10/2018SE |
| K173660 | LenSx Laser SystemOOE · Traditional | 03/27/2018SE |
| K173538 | Clear Care Cleaning & Disinfecting Solution, AOCup Lens Case with AODiscLRX · Special | 12/04/2017SE |
| K172600 | AIR OPTIX COLORS, AIR OPTIX COLORS Toric, AIR OPTIX COLORS MultifocalLPL · Traditional | 10/25/2017SE |
| K172066 | DAILIES AquaComfort Plus (sphere), DAILIES AquaComfort Plus Toric, DAILIES AquaComfort…LPL · Special | 08/09/2017SE |
| K163551 | LenSx Laser SystemOOE · Traditional | 02/03/2017SE |
| K161391 | DAILIES AquaComfort Plus, DAILIES AquaComfort Plus Toric, DACP Multifocal, Focus…LPL · Traditional | 11/30/2016SE |
| K161288 | LenSX Laser SystemOOE · Traditional | 11/16/2016SE |
| K162597 | Clear Care Cleaning & Disinfecting Solution, AOCup Lens Case with AODiscLPN · Special | 10/19/2016SE |
| K162596 | Air Optix ColorsLPL · Special | 10/13/2016SE |
| K160609 | AIR OPTIX plus HydraGlyde, AIR OPTIX plus HydraGlyde for Astigmatism, AIR OPTIX plus…LPL · Traditional | 05/02/2016SE |
| K153643 | Focus DAILIES, Focus DAILIES Toric, Focus DAILIES ProgressivesLPL · Special | 01/20/2016SE |
| K153642 | DAILIES AquaComfort Plus, DAILIES AquaComfort Plus Toric, DAILIES AquaComfort Plus…LPL · Special | 01/20/2016SE |
| K142284 | Clear Care Plus Cleaning & Disinfectiong Solution with HydraglydeLPN · Traditional | 01/26/2015SE |
| K121555 | Centurion Vision SystemHQC · Traditional | 12/21/2012SE |
| K062624 | Next Generation LaserHQF · Traditional | 11/05/2007SE |
| K062865 | Small Volume SyringeFMF · Traditional | 08/23/2007SE |
| K023249 | Alcon Ladarwave Customcornea Wavefront SystemNCF · Abbreviated | 10/18/2002SE |
| K021566 | InfinitiHQC · Traditional | 07/02/2002SE |
| K000637 | Customcornea Measurement Device (CCMD)NCF · Traditional | 05/19/2000SESU |
| K000148 | RGP Multi-Purpose Solution Id 100136MRC · Traditional | 04/11/2000SE |
| K984573 | Opti-Free Express Multi-Action Cleaning and Rewetting DropLPN · Traditional | 09/16/1999SE |
| K990480 | Opti-Free Supraclens Daily Protein RemoverLPN · Traditional | 05/10/1999SE |
| K984575 | Multi-Purpose Disinfecting Solution Id 90746LPN · Special | 01/14/1999SE |
| K983973 | Opti-One Multi-Purpose SolutionLPN · Traditional | 12/18/1998SE |
| K983780 | Multi-Purpose Disinfecting Solution Id 90746LPN · Traditional | 12/18/1998SE |
| K981561 | Liquid Enzyme Id 90133LPN · Traditional | 07/24/1998SE |
| K981571 | Monarch Iol Delivery SystemKYB · Traditional | 07/09/1998SE |
| K981103 | Turbosonics Limited Reuse Ultrasonic TipHQC · Traditional | 06/23/1998SE |
| K981151 | Opti-Free Supraclens Daily Protein Remover/Alcon Wetting, Soaking, Conditioning and…LPN · Traditional | 06/22/1998SE |
| K980292 | Cataract Liquefracture DeviceMUS · Traditional | 05/19/1998SE |
| K974625 | Opti-Free Supraclens Daily Protein RemoverLPN · Traditional | 03/04/1998SE |
| K974624 | Alcon Multi-Purpose Disinfecting Solution Id 90746LPN · Traditional | 03/04/1998SE |
| K974281 | Alcon Contact Lens CaseLRX · Traditional | 01/20/1998SE |
| K973332 | Alcon Multi-Purpose Disinfecting Solution Id 90746LPN · Traditional | 12/02/1997SE |
| K971618 | Alcon Contact Lens CaseLRX · Traditional | 07/14/1997SE |
| K970033 | Monarch Iol Delivery SystemKYB · Traditional | 04/23/1997SE |
| K965185 | Acrypak FolderKYB · Traditional | 03/31/1997SE |
| K962592 | Ophthalas 532 Solid State Photocoagulator, or Equivalent Laser SystemsGEX · Traditional | 09/23/1996SE |
| K955789 | Alcon Series 20000 Legacy Mackool SystemHQC · Traditional | 03/21/1996SE |
| K960261 | Pallikaris BrushHOG · Traditional | 03/11/1996SE |
| K952213 | Alcon Series 20000 Legacy PhacoemulsifierHQC · Traditional | 08/09/1995SE |
| K932062 | Ophthalas 532 Solid State PhotocoagulatorGEX · Traditional | 03/18/1994SE |
| K930517 | Non-Absorbable Surgical SuturesGAR · Traditional | 12/17/1993SE |
| K931620 | Opti-Free Contact Lens CaseLRX · Traditional | 06/28/1993SE |
| K914334 | Alcon(R) FX2(TM) PhotocoagulatorGEX · Traditional | 11/13/1992SE |
| K920641 | Alcon Operating MicroscopesHRM · Traditional | 10/09/1992SE |
| K911587 | K-Sol(Tm)KDN · Traditional | 11/01/1991SE |
| K912130 | TBD KeratoscopeHLQ · Traditional | 08/09/1991SE |
| K912134 | TBD, Lens Measuring DeviceHRJ · Traditional | 07/25/1991SE |
| K911808 | Gemini Ophthalmic Surgery SystemHQC · Traditional | 06/25/1991SE |
| K895434 | Alcon Folding ForcepsHNR · Traditional | 12/04/1989SE |
| K896004 | Alcon Surgical SpongeHOZ · Traditional | 11/02/1989SE |
| K885230 | Mcdonald Folding ForcepsHNR · Traditional | 05/17/1989SE |
| K890303 | Opti-Tears(R)LPN · Traditional | 02/17/1989SE |
| K882723 | Alcon Fluid InjectorDQF · Traditional | 11/08/1988SE |
| K881682 | Alcon Site(R)-Compatible CassetteKYG · Traditional | 07/01/1988SE |
| K880961 | Alcon Surgical Procedure PacksLRO · Traditional | 04/29/1988SE |
| K873548 | Opti-Zyme(R)LPN · Traditional | 09/29/1987SE |
| K873099 | Manual Ophthalmic Surgical InstrumentsHNF · Traditional | 09/04/1987SE |
| K854159 | Ellipti-PunchFZI · Traditional | 11/15/1985SE |
| K822104 | Alcon Indirect OphthalmoscopeHLI · Traditional | 08/10/1982SE |
| K812172 | Contact Lens CleanerHPX · Traditional | 08/31/1981SE |
| K760696 | Remote Control System for MicroscopeEPT · Traditional | 12/16/1976SE |
| K760697 | Evans Arm and Hand RestHRK · Traditional | 11/02/1976SE |
| K760158 | Needles and Sutures, Silk & NylonGAP · Traditional | 08/19/1976SE |
PMA approvals
- P220007 Precision7; Precision7 for Astigmatism; Precision7 Multifocal; Precision7 Multifocal Toric (serafilcon A) Soft Conta · 04/25/2023 · 7 supplements
- P190018 Clareon Aspheric Hydrophobic Acrylic Intraocular Lens (IOL), Clareon Toric Aspheric Hydrophobic Acrylic Intraocular Lens · 01/07/2020 · 49 supplements
- P030008 Wavelight Allegretto Wave Excimer Laser System · 10/10/2003 · 38 supplements
- P020050 Wavelight Allegretto Wave Excimer Laser System · 10/07/2003 · 43 supplements
- P000030 Focus Night & Day (Lotrafilcon a) Soft Contact Lenses · 10/12/2001 · 3 supplements
- P010019 Focus Night and Day (Lotrafilcon a) Soft Contact Lenses · 10/11/2001 · 83 supplements
- P990023 Cellugel(R) Ophthalmic Viscosurgical Device · 02/24/2000 · 18 supplements
- P970043 Ladarvision Excimer Laser System · 11/02/1998 · 23 supplements
- P950018 Perfluoron (Purified Perfluoro-N-Octane Liquid) · 02/29/1996 · 25 supplements
- P930034 SVS Apex Excimer Laser System · 10/20/1995 · 11 supplements
- P930014 Acrysof (R) UV Absorbing Intraocular Lenses · 12/22/1994 · 161 supplements
- P940013 Precision(Tm) UV (Vasurfilcon) · 09/30/1994 · 7 supplements
- P880087 Kelman Multiflex 2 Models: MT3-MT7 & MT2U-MT7U · 01/31/1990 · 30 supplements
- P880094 Dacron Surgical Sutures · 09/22/1989 · 0 supplements
- P890002 Polypropylene Surgical Suture · 05/31/1989 · 0 supplements
- P880010 Intraocular Lens Models C118;C119;C138 and C139 · 10/05/1988 · 14 supplements
- P820079 CDS II (Sodium Chondroitin Sulfate) · 09/30/1986 · 0 supplements
- P840064 Viscoat(Tm)/Dvovisc/Discovisc Ophthalmic Viscosurgical Devices · 04/30/1986 · 89 supplements
- P840060 SM-1, CR-1, & GR-1 Iols · 04/30/1986 · 45 supplements
- P830037 Durasoft(R) 3 for Ext Wear · 04/24/1984 · 50 supplements
- P820021 Softcon (Vifilcon a) Soft Contact Ext Wear Lens · 03/31/1983 · 32 supplements
- P810018 Posterior Chamber Intraocular Lenses · 07/16/1982 · 28 supplements
- P810032 Models B-13F (P-10) & B-1H (P-11) · 04/23/1982 · 53 supplements
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-1644-2009 | Alcon Vitrectomy 25 GA Custom Pak, Catalog/Item #10240-03, 11077-03, 11187-02 and…Specific lots of Alcon 25 GA Trocar Blades do not conform to finished product specifications in that… | 04/29/2009Terminated |
| Z-1643-2009 | Alcon 25 GA Total Plus Pak, Catalog/Item #8065750220; for use with ACCURUS Vitrectomy…Specific lots of Alcon 25 GA Trocar Blades do not conform to finished product specifications in that… | 04/29/2009Terminated |
| Z-0274-2009 | PurePoint System Operator's Manual, Catalog Number 8065751131, Rev. B for use with the…Alcon had identified that indications for use unapproved by the Food and Drug Administration are included in… | 09/26/2008Terminated |
| Z-2441-2008 | MONARCH II IOL Delivery System, Cartridge Model B, part #8065977758, packaged in…Delivery cartridge for implanting intraocular lenses is mislabeled and may result in complicated insertion… | 07/07/2008Terminated |
| Z-0564-2007 | Alcon Custom-Pak, part #11148-02, containing BD Beaver Mini-Blade (part #BD6400 or part…Individually packaged surgical blades, labeled as sterile, found with incomplete seals; blades purchased for… | 12/22/2006Terminated |
| Z-0563-2007 | Alcon Custom-Pak, part #6515-51, containing BD Beaver Mini-Blade (part #BD6400 or part…Individually packaged surgical blades, labeled as sterile, found with incomplete seals; blades purchased for… | 12/22/2006Terminated |
| Z-0562-2007 | Alcon Custom-Pak, part #4917-54, containing BD Beaver Mini-Blade (part #BD6400 or part…Individually packaged surgical blades, labeled as sterile, found with incomplete seals; blades purchased for… | 12/22/2006Terminated |
| Z-0561-2007 | Alcon Custom-Pak, part #2638-17, containing BD Beaver Mini-Blade (part #BD6400 or part…Individually packaged surgical blades, labeled as sterile, found with incomplete seals; blades purchased for… | 12/22/2006Terminated |
| Z-0560-2007 | Alcon Custom-Pak, part #10975-02, containing BD Beaver Mini-Blade (part #BD6400 or part…Individually packaged surgical blades, labeled as sterile, found with incomplete seals; blades purchased for… | 12/22/2006Terminated |
| Z-0431-2007 | AcrySof Intraocular LensIntraocular lenses exposed to extreme temperatures while in storage. | 12/14/2006Terminated |
| Z-0430-2007 | AcrySof ReSTOR Intraocular LensIntraocular lenses exposed to extreme temperatures while in storage. | 12/14/2006Terminated |
| Z-0429-2007 | AcrySof ReSTOR Intraocular LensIntraocular lenses exposed to extreme temperatures while in storage. | 12/14/2006Terminated |