Company · US
Alcon Laboratories
FDA 510(k) clearances and medical device recalls filed under this name, 1976 to 2026. Name variants (Inc, Corp, punctuation) are merged.
90510(k) clearances (1 in 12 months)
16recalls (0 in 12 months)
5recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| LPL | Lenses, Soft Contact, Daily Wear | 22 |
| LPN | Accessories, Soft Lens Products | 15 |
| HQC | Unit, Phacofragmentation | 8 |
| HNN | Knife, Ophthalmic | 5 |
| OOE | Ophthalmic Femtosecond Laser | 5 |
| GEX | Powered Laser Surgical Instrument | 4 |
| KYB | Lens, Guide, Intraocular | 4 |
| LRX | Case, Contact Lens | 4 |
| MFK | Lens, Multifocal Intraocular | 3 |
| HNR | Forceps, Ophthalmic | 2 |
| HQF | Laser, Ophthalmic | 2 |
| MVN | Lens, Contact, (Disposable) | 2 |
| NCF | Aberrometer, Ophthalmic | 2 |
| NGY | Cannula, Trocar, Ophthalmic | 2 |
| DQF | Actuator, Syringe, Injector Type | 1 |
| EPT | Microscope, Surgical | 1 |
| FMF | Syringe, Piston | 1 |
| FZI | Apparatus, Air Handling, Enclosure | 1 |
| GAP | Suture, Nonabsorbable, Silk | 1 |
| GAR | Suture, Nonabsorbable, Synthetic, Polyamide | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 13, 2026 | K254052 | DAILIES TOTAL1®; DAILIES TOTAL1® Multifocal Alcon Laboratories, Inc. | LPL |
| Sep 24, 2025 | K252682 | LenSx Laser System (8065000944) Alcon Laboratories, Inc. | OOE |
| Apr 28, 2025 | K243896 | LenSx Laser System (8065998162) Alcon Laboratories, Inc. | OOE |
| Jan 13, 2025 | K243909 | Precision1; Precision1 for Astigmatism; Dailies Total1; Dailies Total1 for Astigmatism; Dailies Total1 Multifocal; Daili Alcon Laboratories, Inc. | LPL |
| Dec 4, 2024 | K242184 | Alcon 27GA Chandelier (8065000252); Alcon 27+ DS Wide Angle Endoilluminator (8065000253); Alcon 27+ DS Endoilluminator ( Alcon Laboratories, Inc. | MPA |
| Jun 21, 2024 | K233876 | UNITY VCS (8065000296); UNITY CS (8065000297) Alcon Laboratories, Inc. | HQC |
| Jan 10, 2024 | K233902 | Centurion Vision System (Active Sentry) (8065753057) Alcon Laboratories, Inc. | HQC |
| Dec 29, 2023 | K233856 | Precision1; Precision1 for Astigmatism; TOTAL30; TOTAL30 for Astigmatism; TOTAL30 Multifocal Alcon Laboratories, Inc. | LPL |
| Nov 16, 2023 | K232921 | DAILIES TOTAL1®; DAILIES TOTAL1® Toric; DAILIES TOTAL1® Multifocal; DAILIES TOTAL1® Multifocal Toric Alcon Laboratories, Inc. | LPL |
| Apr 20, 2023 | K230785 | Precision1, Precision1 for Astigmatism Alcon Laboratories, Inc. | LPL |
| Sep 15, 2022 | K222500 | AIR OPTIX COLORS Alcon Laboratories, Inc. | LPL |
| Dec 28, 2021 | K212806 | Alcon (serafilcon A) soft contact lenses for daily wear Alcon Laboratories, Inc. | LPL |
| Aug 23, 2021 | K212039 | CLAREON MONARCH IV IOL Delivery System Alcon Laboratories, Inc. | MSS |
| Apr 12, 2021 | K210436 | Total30, Total30 for Astigmatism, Total30 Multifocal, Total30 Multifocal Toric, Total30 Asphere Alcon Laboratories, Inc. | LPL |
| Sep 22, 2020 | K202448 | DAILIES AquaComfort Plus (DACP) / DACP FreshTech / DACP Toric / DACP Multifocal Alcon Laboratories, Inc. | MVN |
| Aug 21, 2020 | K202036 | Focus DAILIES / Focus DAILIES Toric / Focus DAILIES Progressives, DAILIES AquaComfort Plus (DACP) / DACP FreshTech / DAC Alcon Laboratories, Inc. | MVN |
| Jul 31, 2019 | K191795 | AOCup Lens Case with AODisc Alcon Laboratories, Inc. | LPN |
| Mar 26, 2019 | K190392 | WaveLight FS200 Patient Interface Alcon Laboratories, Inc. | GEX |
| Feb 6, 2019 | K190045 | DAILIES Colors, DAILIES Colors Toric, DAILIES Colors Progressives Alcon Laboratories, Inc. | LPL |
| Jan 18, 2019 | K182782 | DAILIES TOTAL1, DAILIES TOTAL1 Asphere, DAILIES TOTAL1 for ASTIGMATISM, DAILIES TOTAL1 Multifocal, DAILIES TOTAL1 Multif Alcon Laboratories, Inc. | LPL |
| Dec 11, 2018 | K182902 | Precision1 Alcon Laboratories, Inc. | LPL |
| Nov 21, 2018 | K181454 | DAILIES AquaComfort Plus, DAILIES AquaComfort Plus FreshTech, DAILIES AquaComfort Plus Toric and DAILIES AquaComfort Plu Alcon Laboratories, Inc. | LPL |
| Aug 3, 2018 | K181796 | FreshLook Handling Tint, FreshLook Colors, FreshLook ColorBlends, FreshLook Dimensions Alcon Laboratories, Inc. | LPL |
| Apr 27, 2018 | K180669 | Focus DAILIES / Focus DAILIES Toric / Focus DAILIES Progressives, DAILIES AquaComfort Plus (DACP) / DACP Toric / DACP Mu Alcon Laboratories, Inc. | LPL |
| Apr 10, 2018 | K180398 | Focus DAILIES / Focus DAILIES Toric / Focus DAILIES Progressives, DAILIES AquaComfort Plus (DACP) / DACP Toric / DACP Mu Alcon Laboratories, Inc. | LPL |
| Mar 27, 2018 | K173660 | LenSx Laser System Alcon Laboratories, Inc. | OOE |
| Dec 4, 2017 | K173538 | Clear Care Cleaning & Disinfecting Solution, AOCup Lens Case with AODisc Alcon Laboratories, Inc. | LRX |
| Oct 25, 2017 | K172600 | AIR OPTIX COLORS, AIR OPTIX COLORS Toric, AIR OPTIX COLORS Multifocal Alcon Laboratories, Inc. | LPL |
| Aug 9, 2017 | K172066 | DAILIES AquaComfort Plus (sphere), DAILIES AquaComfort Plus Toric, DAILIES AquaComfort Plus Multifocal Alcon Laboratories, Inc. | LPL |
| Feb 3, 2017 | K163551 | LenSx Laser System Alcon Laboratories, Inc. | OOE |
| Nov 30, 2016 | K161391 | DAILIES AquaComfort Plus, DAILIES AquaComfort Plus Toric, DACP Multifocal, Focus DAILIES, Focus DAILIES Toric, Focus DAI Alcon Laboratories, Inc. | LPL |
| Nov 16, 2016 | K161288 | LenSX Laser System Alcon Laboratories, Inc. | OOE |
| Oct 19, 2016 | K162597 | Clear Care Cleaning & Disinfecting Solution, AOCup Lens Case with AODisc Alcon Laboratories, Inc. | LPN |
| Oct 13, 2016 | K162596 | AIR OPTIX COLORS Alcon Laboratories, Inc. | LPL |
| May 2, 2016 | K160609 | AIR OPTIX plus HydraGlyde, AIR OPTIX plus HydraGlyde for Astigmatism, AIR OPTIX plus HydraGlyde Multifocal, AIR OPTIX pl Alcon Laboratories, Inc. | LPL |
| Jan 20, 2016 | K153643 | Focus DAILIES, Focus DAILIES Toric, Focus DAILIES Progressives Alcon Laboratories, Inc. | LPL |
| Jan 20, 2016 | K153642 | DAILIES AquaComfort Plus, DAILIES AquaComfort Plus Toric, DAILIES AquaComfort Plus Multifocal Alcon Laboratories, Inc. | LPL |
| Jan 26, 2015 | K142284 | CLEAR CARE PLUS CLEANING & DISINFECTIONG SOLUTION WITH HYDRAGLYDE Alcon Laboratories, Inc. | LPN |
| Dec 21, 2012 | K121555 | CENTURION VISION SYSTEM Alcon Laboratories, Inc. | HQC |
| Nov 5, 2007 | K062624 | NEXT GENERATION LASER Alcon Laboratories | HQF |
| Aug 23, 2007 | K062865 | SMALL VOLUME SYRINGE Alcon Laboratories | FMF |
| Oct 18, 2002 | K023249 | ALCON LADARWAVE CUSTOMCORNEA WAVEFRONT SYSTEM Alcon Laboratories, Inc. | NCF |
| Jul 2, 2002 | K021566 | INFINITI Alcon Laboratories, Inc. | HQC |
| May 19, 2000 | K000637 | CUSTOMCORNEA MEASUREMENT DEVICE (CCMD) Alcon Laboratories, Inc. | NCF |
| Apr 11, 2000 | K000148 | RGP MULTI-PURPOSE SOLUTION ID 100136 Alcon Laboratories | MRC |
| Sep 16, 1999 | K984573 | OPTI-FREE EXPRESS MULTI-ACTION CLEANING AND REWETTING DROP Alcon Laboratories | LPN |
| May 10, 1999 | K990480 | OPTI-FREE SUPRACLENS DAILY PROTEIN REMOVER Alcon Laboratories | LPN |
| Jan 14, 1999 | K984575 | MULTI-PURPOSE DISINFECTING SOLUTION ID 90746 Alcon Laboratories | LPN |
| Dec 18, 1998 | K983973 | OPTI-ONE MULTI-PURPOSE SOLUTION Alcon Laboratories | LPN |
| Dec 18, 1998 | K983780 | MULTI-PURPOSE DISINFECTING SOLUTION ID 90746 Alcon Laboratories | LPN |
Newest 50 of 90.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 26, 2009 | Alcon Laboratories, Inc Alcon Vitrectomy 25 GA Custom Pak, Catalog/Item #10240-03, 11077-03, 11187-02 and 13305-01; distributed by Alcon Laboratories, Inc., Fort Worth, TX 76134. Terminated |
NGY | K880961 |
| May 26, 2009 | Alcon Laboratories, Inc Alcon 25 GA Total Plus Pak, Catalog/Item #8065750220; for use with ACCURUS Vitrectomy System; distributed by Alcon Laboratories, Inc., Fort Worth, TX 76134. Terminated |
NGY | K911808 |
| Nov 6, 2008 | Alcon Laboratories, Inc. PurePoint System Operator's Manual, Catalog Number 8065751131, Rev. B for use with the Alcon PurePoint Laser, Catalog Number 8065750597
Indicated for use in photocoagulation of both anterior and pos Terminated |
HQF | None listed |
| Sep 23, 2008 | Alcon Laboratories, Inc MONARCH II IOL Delivery System, Cartridge Model B, part #8065977758, packaged in pouches, 10 pouches/carton, and labeled in part ***Alcon Laboratories Fort Worth, Texas 76134 USA***for AcrySof IOLs* Terminated |
KYB | K001157 |
| Mar 1, 2007 | Alcon Laboratories, Inc Alcon Custom-Pak, part #11148-02, containing BD Beaver Mini-Blade (part #BD6400 or part #BD6900); individual blades repackaged into custom ophthalmic surgical packs and resterilized by Alcon Laborator Terminated |
HNN | None listed |
| Mar 1, 2007 | Alcon Laboratories, Inc Alcon Custom-Pak, part #6515-51, containing BD Beaver Mini-Blade (part #BD6400 or part #BD6900); individual blades repackaged into custom ophthalmic surgical packs and resterilized by Alcon Laboratori Terminated |
HNN | None listed |
| Mar 1, 2007 | Alcon Laboratories, Inc Alcon Custom-Pak, part #4917-54, containing BD Beaver Mini-Blade (part #BD6400 or part #BD6900); individual blades repackaged into custom ophthalmic surgical packs and resterilized by Alcon Laboratori Terminated |
HNN | None listed |
| Mar 1, 2007 | Alcon Laboratories, Inc Alcon Custom-Pak, part #2638-17, containing BD Beaver Mini-Blade (part #BD6400 or part #BD6900); individual blades repackaged into custom ophthalmic surgical packs and resterilized by Alcon Laboratori Terminated |
HNN | None listed |
| Mar 1, 2007 | Alcon Laboratories, Inc Alcon Custom-Pak, part #10975-02, containing BD Beaver Mini-Blade (part #BD6400 or part #BD6900); individual blades repackaged into custom ophthalmic surgical packs and resterilized by Alcon Laborator Terminated |
HNN | None listed |
| Feb 15, 2007 | Alcon Laboratories, Inc AcrySof Intraocular Lens Terminated |
MFK | None listed |
| Feb 15, 2007 | Alcon Laboratories, Inc AcrySof ReSTOR Intraocular Lens Terminated |
MFK | None listed |
| Feb 15, 2007 | Alcon Laboratories, Inc AcrySof ReSTOR Intraocular Lens Terminated |
MFK | None listed |
| Jun 21, 2006 | Alcon Laboratories, Inc. LADARVision Excimer Laser System. Terminated |
LZS | None listed |
| Dec 17, 2003 | Alcon Laboratories, Inc ISPAN patient bracelet, given to patients post surgery to warn of further use of dinitrogen monoxide Terminated |
LPO | None listed |
| Aug 6, 2003 | Alcon Laboratories, Inc. ''Alcon Ladarwave CustomCornea Wavefront System'' Aberrometer software Version 7.91 Terminated |
K023249 | |
| Mar 6, 2003 | Alcon Laboratories, Inc SKBM Microkeratome cutting tool Terminated |
HNO | K980675 |