Alcon Laboratories
Duluth, GA, US
Alcon Laboratories appears in FDA device records in Duluth, GA. FDA records list 152 510(k) clearances between and , 1,500 PMA records and 10 registered establishments. As of , FDA records show 160 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
5 namesFDA records resolved to Alcon Laboratories carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Alcon Refractive Horizons, Inc.recall
- Alcon Research Laboratories Ltd.enforcement report, recall
- Alcon Research, LLCregistration, 510(k), PMA, enforcement report, recall
- Alcon Research, Ltd. Dba Alcon Laboratories, Inc.510(k), PMA, recall
- Ciba Vision Corporationregistration, 510(k), PMA, recall
510(k) clearance history
Showing 50 of 152FDA records hold 152 510(k) clearances for Alcon Laboratories between 1976 and 2026. The busiest year on record is 1998, with 12. The most recent is 2026, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1976 | 3 |
| 1981 | 1 |
| 1982 | 1 |
| 1985 | 1 |
| 1987 | 2 |
| 1988 | 3 |
| 1989 | 4 |
| 1991 | 4 |
| 1992 | 2 |
| 1993 | 2 |
| 1994 | 3 |
| 1995 | 1 |
| 1996 | 4 |
| 1997 | 5 |
| 1998 | 12 |
| 1999 | 5 |
| 2000 | 6 |
| 2001 | 6 |
| 2002 | 7 |
| 2003 | 8 |
| 2004 | 4 |
| 2005 | 5 |
| 2006 | 2 |
| 2007 | 2 |
| 2008 | 2 |
| 2009 | 3 |
| 2010 | 2 |
| 2011 | 3 |
| 2012 | 4 |
| 2013 | 1 |
| 2014 | 3 |
| 2015 | 1 |
| 2016 | 7 |
| 2017 | 6 |
| 2018 | 6 |
| 2019 | 5 |
| 2020 | 2 |
| 2021 | 3 |
| 2022 | 1 |
| 2023 | 3 |
| 2024 | 3 |
| 2025 | 3 |
| 2026 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K254052 | DAILIES TOTAL1®; DAILIES TOTAL1® Multifocal | LPL | Substantially Equivalent | |
| K252682 | LenSx Laser System (8065000944) | OOE | Substantially Equivalent | |
| K243896 | LenSx Laser System (8065998162) | OOE | Substantially Equivalent | |
| K243909 | Precision1; Precision1 for Astigmatism; Dailies Total1; Dailies Total1 for Astigmatism; Dailies Total1 Multifocal; Dailies Total1 Multifocal Toric | LPL | Substantially Equivalent | |
| K242184 | Alcon 27GA Chandelier (8065000252); Alcon 27+ DS Wide Angle Endoilluminator (8065000253); Alcon 27+ DS Endoilluminator (8065000256); | MPA | Substantially Equivalent | |
| K233876 | UNITY VCS (8065000296); UNITY CS (8065000297) | HQC | Substantially Equivalent | |
| K233902 | Centurion™ Vision System (Active Sentry™) (8065753057) | HQC | Substantially Equivalent | |
| K233856 | Precision1; Precision1 for Astigmatism; TOTAL30; TOTAL30 for Astigmatism; TOTAL30 Multifocal | LPL | Substantially Equivalent | |
| K232921 | DAILIES TOTAL1®; DAILIES TOTAL1® Toric; DAILIES TOTAL1® Multifocal; DAILIES TOTAL1® Multifocal Toric | LPL | Substantially Equivalent | |
| K230785 | Precision1, Precision1 for Astigmatism | LPL | Substantially Equivalent | |
| K222500 | AIR OPTIX COLORS | LPL | Substantially Equivalent | |
| K212806 | Alcon (serafilcon A) soft contact lenses for daily wear | LPL | Substantially Equivalent | |
| K212039 | CLAREON MONARCH IV IOL Delivery System | MSS | Substantially Equivalent | |
| K210436 | Total30, Total30 for Astigmatism, Total30 Multifocal, Total30 Multifocal Toric, Total30 Asphere | LPL | Substantially Equivalent | |
| K202448 | DAILIES AquaComfort Plus (DACP) / DACP FreshTech / DACP Toric / DACP Multifocal | MVN | Substantially Equivalent | |
| K202036 | Focus DAILIES / Focus DAILIES Toric / Focus DAILIES Progressives, DAILIES AquaComfort Plus (DACP) / DACP FreshTech / DACP Toric / DACP Multifocal | MVN | Substantially Equivalent | |
| K191650 | LEGION System | HQC | Substantially Equivalent | |
| K191795 | AOCup Lens Case with AODisc | LPN | Substantially Equivalent | |
| K190392 | WaveLight FS200 Patient Interface | GEX | Substantially Equivalent | |
| K190045 | DAILIES Colors, DAILIES Colors Toric, DAILIES Colors Progressives | LPL | Substantially Equivalent | |
| K182782 | DAILIES TOTAL1, DAILIES TOTAL1 Asphere, DAILIES TOTAL1 for ASTIGMATISM, DAILIES TOTAL1 Multifocal, DAILIES TOTAL1 Multifocal Toric | LPL | Substantially Equivalent | |
| K182902 | Precision1 | LPL | Substantially Equivalent | |
| K181454 | DAILIES AquaComfort Plus, DAILIES AquaComfort Plus FreshTech, DAILIES AquaComfort Plus Toric and DAILIES AquaComfort Plus Multifocal | LPL | Substantially Equivalent | |
| K181796 | FreshLook Handling Tint, FreshLook Colors, FreshLook ColorBlends, FreshLook Dimensions | LPL | Substantially Equivalent | |
| K180669 | Focus DAILIES / Focus DAILIES Toric / Focus DAILIES Progressives, DAILIES AquaComfort Plus (DACP) / DACP Toric / DACP Multifocal, FreshLook One-Day, DAILIES Total 1 / DAILIES Total 1 Multifocal | LPL | Substantially Equivalent | |
| K180398 | Focus DAILIES / Focus DAILIES Toric / Focus DAILIES Progressives, DAILIES AquaComfort Plus (DACP) / DACP Toric / DACP Multifocal, FreshLook One-Day, DAILIES Total1, DAILIES Total1 Multifocal | LPL | Substantially Equivalent | |
| K173660 | LenSx Laser System | OOE | Substantially Equivalent | |
| K173538 | Clear Care Cleaning & Disinfecting Solution, AOCup Lens Case with AODisc | LRX | Substantially Equivalent | |
| K172600 | AIR OPTIX COLORS, AIR OPTIX COLORS Toric, AIR OPTIX COLORS Multifocal | LPL | Substantially Equivalent | |
| K172066 | DAILIES AquaComfort Plus (sphere), DAILIES AquaComfort Plus Toric, DAILIES AquaComfort Plus Multifocal | LPL | Substantially Equivalent | |
| K161794 | CENTURION Vision System (Active SentryTM) | HQC | Substantially Equivalent | |
| K170520 | HyperVit Vitrectomy Probe, 23 GA, HyperVit Vitrectomy Probe, 25+, HyperVit Vitrectomy Probe, 27+ | MLZ | Substantially Equivalent | |
| K163551 | LenSx Laser System | OOE | Substantially Equivalent | |
| K161391 | DAILIES AquaComfort Plus, DAILIES AquaComfort Plus Toric, DACP Multifocal, Focus DAILIES, Focus DAILIES Toric, Focus DAILIES Progressives | LPL | Substantially Equivalent | |
| K161288 | LenSX Laser System | OOE | Substantially Equivalent | |
| K162597 | Clear Care Cleaning & Disinfecting Solution, AOCup Lens Case with AODisc | LPN | Substantially Equivalent | |
| K162596 | AIR OPTIX COLORS | LPL | Substantially Equivalent | |
| K160609 | AIR OPTIX plus HydraGlyde, AIR OPTIX plus HydraGlyde for Astigmatism, AIR OPTIX plus HydraGlyde Multifocal, AIR OPTIX plus HydraGlyde Multifocal Toric | LPL | Substantially Equivalent | |
| K153643 | Focus DAILIES, Focus DAILIES Toric, Focus DAILIES Progressives | LPL | Substantially Equivalent | |
| K153642 | DAILIES AquaComfort Plus, DAILIES AquaComfort Plus Toric, DAILIES AquaComfort Plus Multifocal | LPL | Substantially Equivalent | |
| K142284 | CLEAR CARE PLUS CLEANING & DISINFECTIONG SOLUTION WITH HYDRAGLYDE | LPN | Substantially Equivalent | |
| K141476 | WAVELIGHT FS200 LASER SYSTEM | OOE | Substantially Equivalent | |
| K141065 | CONSTELLATION VISION SYSTEM | HQE | Substantially Equivalent | |
| K133176 | AIR OPTIX COLORS, AIR OPTIX COLORS TORIC, AIR OPTIX COLORS MULTIFOCAL | LPL | Substantially Equivalent | |
| K123994 | DAILIES AQUACOMFORT PLUS, DAILIES AQUACOMFORT PLUS TORIC, DAILIES AQUACOMFORT PLUS MULTIFOCAL | LPL | Substantially Equivalent | |
| K121555 | CENTURION VISION SYSTEM | HQC | Substantially Equivalent | |
| K121031 | WAVELIGHT FS200 PATIENT INTERFACE 1505 | GEX | Substantially Equivalent | |
| K113168 | DAILIES TOTAL DALIES TOTAL FOR ASTIGMATISM DAILIES TOTAL MULTIFOCAL DAILIES TOTAL MULTIFOCAL TORIC | LPL | Substantially Equivalent | |
| K112977 | MONARCH III IOL DELIVERY SYSTEM, MONARCH III C CARTRIDGE, MONARCH III HANDPIECE (H4) | MSS | Substantially Equivalent | |
| K110951 | 27+ ULTRAVIT PROBE, 27+ FLEX-TIP LASER PROBE, 27+ ENDOILLUMINATOR PROBE, 27+ VALVED ENTRY SYSTEM, 27+ INFUSION CANNULA | HQB | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1053053 | 1053053 | Alcon Research, LLC | 11440 JOHNS CREEK PARKWAY, DULUTH, GA 30097 US | 2026 | |
| 1119421 | 1119421 | Alcon Research, LLC | 246 KYLE LANE, HUNTINGTON, WV 25702 US | 2026 | |
| 1610287 | 1610287 | Alcon Research, LLC | 6201 SOUTH FREEWAY, Fort Worth, TX 76134 US | 2026 | and 17 more, listed in full below |
| 1644019 | 1000117501 | Alcon Research, LLC | 9965 BUFFALO SPEEDWAY, Houston, TX 77054 US | 2026 | and 8 more, listed in full below |
| 2028159 | 1000125771 | Alcon Research, LLC | 15800 Alton Pkwy, IRVINE, CA 92618 US | 2026 | and 10 more, listed in full below |
| 2523835 | 2523835 | Alcon Research, LLC | 714 COLUMBIA AVE., Sinking Spring, PA 19608 US | 2026 | and 13 more, listed in full below |
| 3007530141 | 3007530141 | Alcon Research, LLC | 2 Vision Lane, Lesage, WV 25537 US | 2026 | |
| 3010208880 | 3010208880 | Alcon Research, LLC | 20511 Lake Forest Dr, Lake Forest, CA 92630 US | 2026 | and 12 more, listed in full below |
| 3013497605 | 3013497605 | Alcon Research, LLC | 700 Old Fritztown Rd, Sinking Spring, PA 19608 US | 2026 | |
| 9610813 | 3002806704 | CIBA VISION GMBH | INDUSTRIERING 1, GROSSWALLSTADT Bavaria 63868 DE | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- LPNAccessories, Soft Lens Products
- LYLAccessories, Solution, Ultrasonic Cleaners For Lenses
- DQFActuator, Syringe, Injector Type
- LZPAid, Surgical, Viscoelastic
- FZIApparatus, Air Handling, Enclosure
- HQRApparatus, Cautery, Radiofrequency, Ac-Powered
- HOGBurr, Corneal, Battery-Powered
- FWJCamera, Cine, Microsurgical, Without Audio
- HMXCannula, Ophthalmic
- LRXCase, Contact Lens
- GBXCatheter, Irrigation
- MOECollagen Corneal Shield
- HNYCystotome
- KYGDevice, Irrigation, Ocular Surgery
- HMTDrape, Patient, Ophthalmic
- MPAEndoilluminator
- LZSExcimer Laser System
- LWLFluid, Intraocular
- HNRForceps, Ophthalmic
- HPAFrame, Trial, Ophthalmic
- LPOGases Used Within Eye To Place Pressure On Detached Retina
- LROGeneral Surgery Tray
- KYFImplant, Eye Valve
- HQEInstrument, Vitreous Aspiration And Cutting, Ac-Powered
- HQLIntraocular Lens
- HNOKeratome, Ac-Powered
- HLQKeratoscope, Ac-Powered
- HNNKnife, Ophthalmic
- HQFLaser, Ophthalmic
- HQDLens, Contact (Other Material) - Daily
- HPXLens, Contact (Polymethylmethacrylate)
- KYBLens, Guide, Intraocular
- MJPLens, Intraocular, Toric Optics
- MFKLens, Multifocal Intraocular
- LPLLenses, Soft Contact, Daily Wear
- LPMLenses, Soft Contact, Extended Wear
- HRMMicroscope, Operating & Accessories, Ac-Powered, Ophthalmic
- EPTMicroscope, Surgical
- HLIOphthalmoscope, Ac-Powered
- HQBPhotocoagulator And Accessories
- GEXPowered Laser Surgical Instrument
- CANRegulator, Pressure, Gas Cylinder
- HNFScissors, Ophthalmic
- HPCSet, Lens, Trial, Ophthalmic
- HOYShield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)
- HNCSpecula, Ophthalmic
- HOZSponge, Ophthalmic
- HMFStand, Instrument, Ac-Powered, Ophthalmic
- KYDStrip, Schirmer
- GAPSuture, Nonabsorbable, Silk
- GARSuture, Nonabsorbable, Synthetic, Polyamide
- GASSuture, Nonabsorbable, Synthetic, Polyester
- GAWSuture, Nonabsorbable, Synthetic, Polypropylene
- FMFSyringe, Piston
- LOHSystem, Identification, Contact Lens
- KDNSystem, Perfusion, Kidney
- HRKTable, Instrument, Manual, Ophthalmic
- HRJTable, Instrument, Powered, Ophthalmic
- HQCUnit, Phacofragmentation
- MLZVitrectomy, Instrument Cutter
Recall records
Showing 25 of 160| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0939-2026 | Brand Name: Alcon Laboratories, Inc. Product Name: Custom Pak Model/Catalog Numbers: 9903-20, 17188-04, 19762-03, 19203-04, 19203-04, 17957-10 Software Version: N/A Product Description: Alcon Custom Paks are customer-designed sterile surgical procedure packs / convenience kits intended for use by trained ophthalmic surgeons in a variety of ophthalmic surgeries. Custom Pak is a collection of various ophthalmic surgical instruments and the necessary materials necessary to perform an ophthalmic surgical procedure. Component: N/A | Ophthalmic procedure packs may have incomplete seals affecting sterility. | Class I | Open, Classified | |
| Z-0326-2026 | Alcon PRECISION1 One-Day Contact Lenses, -2.25D. | Potential for a weak seal in some units resulting in compromise in sterility. | Class II | Open, Classified | |
| Z-0581-2026 | CONSTELLATION ULTRAVIT 10K and CONSTELLATION HYPERVIT 20K, Description/REF: 25+ TOTALPLUS CP PAK 20K CPM BWV .9 IU/ 8065000093; 25+ TOTALPLUS CP PAK 20K CPM BV .9 IU/ 8065000095; 27+ TOTALPLUS CP PAK 20K CPM BV .9 IU/ 8065000096; 23GA BEVEL ULTRAVIT 10,000 CPM/ 8065752413; 25+ BEVEL ULTRAVIT 10,000 CPM/ 8065752415; 27+ BEVEL ULTRAVIT 10,000 CPM/ 8065752417; TOTAL PLUS,23G,10K VALVE STD/ 8065752435; TOTAL PLUS,23GA,10K VALVE WD/ 8065752436; TOTAL PLUS,25+,10K VALVE STD/ 8065752437; TOTAL PLUS,25+,10K VALVE WD/ 8065752438; TOTAL PLUS,27+,10K VALVE STD/ 8065752439; 23G CMB PAK 10K CPM,V,STD 0.9/ 8065752448; 23G CMB PAK 10K CPM,V,WA 0.9/ 8065752449; 25+ CMB PAK 10K CPM,V,STD 0.9/ 8065752450; 25+ CMB PAK 10K CPM,V,WA 0.9/ 8065752451; 27+ CMB PAK 10K CPM,V,STD 0.9/ 8065752452; 25+TTLPL VPK 20000CPM BEV VAL/ 8065753106; 27+TTLPL VPK 20000CPM BEV VL/ 8065753109; HYPERVIT 25+BEV 20000 CPM/ 8065830026; HYPERVIT 27+BEV 20000 CPM/ 8065830027; 25+ TTL PLUS VPAK 20000CPM BWV/ 8065830077; 25G VIT 25G OPTICARE EYE HLTH CTR/ 10924-15; VITRECTOMY 25G NORTHSIDE HOSP/ 11220-25; VITRECTOMY 25G NORTHSIDE HOSP/ 11220-27; 23G CONSTELLATION NORTHERN MICH SPPLY AL/ 12568-09; AUS-25GA VIT RET BRISBANE WATERS/ 12641-13; AUS-25GA VIT RET BRISBANE WATERS/ 12641-14; AUS-23GA 10K COMBINED VR PAK NEW CHILDRE/ 12852-16; 23G VIT CONSTELLATION LOMA LINDA COMM HO/ 13501-08; 25+G 20K VIT CONSTELLATION LOMA LINDA CO/ 13502-10; 23G VIT CONSTELLATION VALVED BAYSTATE ME/ 13591-13; 25G CONSTELLATION VALVED BAYSTATE MEDICA/ 13592-15; VITRECTOMY 25G V A HOSPITAL/ 14129-10; J-COMB PAK - 25G 20K CVS NAKAGAMI HOSPIT/ 14283-12; CDN-CVS VIT 25G VE 10K TIMMINS DH/ 14501-09; CDN-CVS VIT 25G+ VE 10K CIUSSS MCQ/ 14512-09; CDN-CVS VIT 25G+ VE 10K CIUSSS MCQ/ 14512-10; CDN-CVS VIT 23G 10K WA SASKATOON HR/ 14532-06; CDN-CVS VIT 23G 10K WA SASKATOON HR/ 14532-07; CDN-CVS VIT 10K 25G+ HSC, ST JOHN'S/ 14540-08; CDN-CVS COMBO 23G VE 10K HD KINGSTON/ 14541-16; CDN-CVS VIT 25G+ 20K BV JEWISH GH/ 14597-07; CDN-CVS VIT 23G 10K ROCKYVIEW HOSPITAL/ 14603-15; CDN-CVS COMBO 25G VE 10K TIMMINS DH/ 14669-10; CDN-CVS COMBO 25G VE 10K TIMMINS DH/ 14669-11; CDN-CVS VIT 23G VE ROYAL ALEXANDRA HOSP/ 14671-09; CDN-CVS VIT 25G+ 10K ROCKYVIEW HOSPITAL/ 14672-11; CDN-CVS VIT 25G+ BWV 20K CUSM/MUHC/ 14873-06; CDN-CVS VIT 25G+ BWV 20K CUSM-MUHC/ 14873-07; CDN-VIT 23G VE 10K ST MICHAEL'S HOSP/ 14955-08; CDN-VIT 23G VE 10K ST MICHAELS HOSP/ 14955-09; CDN-CVS 25G+ VIT VE 10K ST MICHAEL'S/ 14956-07; CDN-CVS 25G+ VIT VE 10K ST MICHAELS/ 14956-08; CDN-CVS VIT 25G+ 10K WESTERN MH/ 15006-06; CDN-CVS VIT 25G+ 20K WA WESTERN MH/ 15006-07; CDN-CVS COMBO 23G 10K ROCKYVIEW HOSPITAL/ 15108-09; CDN-CVS CMB 25G+ V 10K OAKVILLE-TRAFALGA/ 15167-08; 25G PLUS VITRECTOMY PEACE HEALTH ST JOSE/ 15223-13; CDN-VIT 23G 10K GRM741746 CUO-HSS/ 15294-14; CDN-COMBO 23G 10K GRM741759 CUO-HSS/ 15295-12; CDN-CVS VIT 25G+ VE 10K MISERICORDIA HC/ 15318-05; CDN-CVS VIT 25G+ VE 10K MISERICORDIA HC/ 15318-06; CDN-CVS VIT 25G+ VE 10K MISERICORDIA HC/ 15318-07; CDN-CVS COMBO 23G V 10K ST MICHAEL'S HSP/ 15324-07; CDN-COMBO 25G 20K GRM743287 CUO-HSS/ 15421-13; CDN-COMBO 25G 20K GRM743287 CUO-HSS/ 15421-14; CDN-UHN 23G COMBO VE 10K TORONTO WESTERN/ 15455-08; CDN-UHN 23G COMBO VE 10K TORONTO WESTERN/ 15455-09; CDN-UHN 23G COMBO VE 10K TORONTO WESTERN/ 15455-10; CDN-UHN 23G VIT VE 10K TORONTO WESTERN/ 15456-04; CDN-UHN 23G VIT VE 10K TORONTO WESTERN/ 15456-05; CDN-UHN 23G VIT VE 10K TORONTO WESTERN/ 15456-06; CDN-CVS 23G COMBO VE 10K SUNNYBROOK GH/ 15464-05; CDN-CVS 23G VIT VE 10K SUNNYBROOK GH/ 15465-05; 23G VIT PACK CALLAHAN EYE FOUNDATION HOS/ 15491-05; 23G VIT PACK CALLAHAN EYE FOUNDATION HOS/ 15491-06; 27G VIT PACK CALLAHAN EYE FOUNDATION HOS/ 15492-02; 27G VIT PACK CALLAHAN EYE FOUNDATION HOS/ 15492-03; 25G+ VIT PACK CALLAHAN EYE FOUNDATION HO/ 15493-05; 25G+ VIT PACK CALLAHAN EYE FOUNDATION HO/ 15493-06; CDN-CVS VIT 25G+ 10K PASQUA HOSPITAL/ 15525-04; CDN-CVS COMBO 23G VE 10K KENSINGTON EI/ 15552-05; CDN-CVS 23G VIT VE 10K KENSINGTON EYE IN/ 1 | XXX | Class II | Open, Classified | |
| Z-0308-2026 | Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity and Constellation surgical consoles Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List' 8065000356 27GA HP ENTRY SYSTEM, 4 MM 1 COUNT 8065000358 25GA HP ENTRY SYSTEM, 6 MM 1 COUNT 8065000359 27GA HP ENTRY SYSTEM, 6 MM 1 COUNT 8065000467 25GA INFUSION CANNULA(4&6MM ES)+TRAY+TMD 8065000468 27GA INFUSION CANNULA(4&6MM ES)+TRAY+TMD Software Version: N/A Product Description: These products are standalone accessory devices meant for vitrectomy surgical procedures. They interface with a corresponding Alcon surgical console. Component: N/A | Due to incomplete seals in the pouch which provide the sterile barrier. | Class II | Open, Classified | |
| Z-0307-2026 | Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity and Constellation surgical consoles Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List' 8065000252 UNITY 27 GA CHANDELIER 8065000253 UNITY 27+DS WIDE ANGLE LIGHT PROBE Software Version: N/A Product Description: These products are standalone accessory devices meant for vitrectomy surgical procedures. They interface with a corresponding Alcon surgical console. Component: N/A | Due to incomplete seals in the pouch which provide the sterile barrier. | Class II | Open, Classified | |
| Z-0306-2026 | Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity and Constellation surgical consoles Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List' 8065000393 UNITY HP VISCOUS FLUID CONTROL VFC PACK Software Version: N/A Product Description: These products are standalone accessory devices meant for vitrectomy surgical procedures. They interface with a corresponding Alcon surgical console. Component: N/A | Due to incomplete seals in the pouch which provide the sterile barrier. | Class II | Open, Classified | |
| Z-0305-2026 | Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity and Constellation surgical consoles Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List' 8065750918 PAK,I/A LINE,NGVS 8065750957 ASSY,SHIP,CONSTELLATION VFC 8065750972 ENDOILLUMATOR,RFID,23G 8065751014 CONST AUTO GAS FILL PAK 8065751014 CONST AUTO GAS FILL PAK 8065751441 ENDOILLUMINATOR,RFID,25G 8065751577 CHANDELIER,25GA,W/RFID Software Version: N/A Product Description: These products are standalone accessory devices meant for vitrectomy surgical procedures. They interface with a corresponding Alcon surgical console. Component: N/A | Due to incomplete seals in the pouch which provide the sterile barrier. | Class II | Open, Classified | |
| Z-0304-2026 | Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity and Constellation surgical consoles Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List' 8065000250 UNITY 27+DS HYPERVIT 30K VIT PROBE 8065753168 UNITY 25+ 7.5K ANTERIOR VIT PROBE 8065753179 UNITY 25+ HYPERVIT 30K VIT PROBE Software Version: N/A Product Description: These products are standalone accessory devices meant for vitrectomy surgical procedures. They interface with a corresponding Alcon surgical console. Component: N/A | Due to incomplete seals in the pouch which provide the sterile barrier. | Class II | Open, Classified | |
| Z-2110-2025 | Brand Name: Alcon Laboratories, Inc. Product Name: Custom Pak Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List' Software Version: N/A Product Description: Alcon Custom Paks are customer-designed sterile surgical procedure packs / convenience kits intended for use by trained ophthalmic surgeons in a variety of ophthalmic surgeries. Custom Pak is a collection of various ophthalmic surgical instruments and the necessary materials necessary to perform an ophthalmic surgical procedure. Component: N/A | Due to the potential that some units within specific lots were damaged during the manufacturing process. The area of damage is within the same area of the lidding. While the damage in the lidding is visibly noticeable, due to risk of sterility being compromised. | Class II | Open, Classified | |
| Z-2109-2025 | Brand Name: Alcon Laboratories, Inc. Product Name: Constellation Vision System Combined Procedure Pak Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List' Software Version: N/A Product Description: Surgical procedure pack to interface with Alcon Constellation Surgical console. Component: N/A | Due to the potential that some units within specific lots were damaged during the manufacturing process. The area of damage is within the same area of the lidding. While the damage in the lidding is visibly noticeable, due to risk of sterility being compromised. | Class II | Open, Classified | |
| Z-2108-2025 | Brand Name: Alcon Laboratories, Inc. Product Name: Constellation Vision System Vitrectomy Procedure Pak Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List' Software Version: N/A Product Description: Surgical procedure pack to interface with Alcon Constellation Surgical console. Component: N/A | Due to the potential that some units within specific lots were damaged during the manufacturing process. The area of damage is within the same area of the lidding. While the damage in the lidding is visibly noticeable, due to risk of sterility being compromised. | Class II | Open, Classified | |
| Z-1293-2025 | Alcon Custom Pak with Non-Latex Symbol, Pak: 12771-18, 18050-10, 18252-17, 12698-09, 15632-10, 3141-45, 12630-07, 18925-05, 19265-05, 13894-16, 17550-08, 12236-18, 11854-15, 8043-29, 12466-17, 15599-17, 14764-09, 13194-16, 17069-09 | Customer-designed sterile surgical procedure packs contain latex components as specified; but, the content label sealed within the transparent sterile pouch contains the symbol for a latex-free product. If users or patients with latex sensitivity come into contact with latex, an allergic reaction may occur. | Class II | Open, Classified | |
| Z-0835-2025 | Brand Name: Alcon Product Name: Monarch III D Delivery Cartridge Model/Catalog Number: 8065977763 Product Description: Monarch III D delivery cartridge Lens Guide, Intraocular Component: N/A | Increase in complaints associated with a molding defect within the inner lumen of delivery cartridges which could result in a scratch on the intraocular lens (IOL) upon delivery. | Class II | Open, Classified | |
| Z-0490-2025 | a) Alcon Custom-Pak CONSTELLATION 25G PLUS CHRISTIANA CARE HLTH SERV, # 15340-11, containing TUBING, SALEM SUMP, 14 FR; b) Alcon Custom-Pak DR GREEN VITRECTOMY MERCY HOSPITAL, # 6557-59 and # 6557-60 each containing TUBING, SALEM SUMP, 18 FR; c) VITRECTOMY ILLINOIS MASONIC MED CTR, # 9456-59, # 9456-60, and # 9456-61 each containing TUBING, SALEM SUMP, 18 FR; d) VITRECTOMY MCGEE EYE SURG CTR, # 12216-12, # 12216-14, and # 12216-15, each containing TUBING, SALEM SUMP, 14 FR. | Reported breakage in the tubing Anti-Reflux Valve (ARV) due to improper use. As a result, changes to labeling were made. | Class III | Open, Classified | |
| Z-3313-2024 | DAILIES TOTAL1, DAILIES TOTAL1 for Astigmatism, DAILIES TOTAL1 Multifocal, TOTAL30 Sphere, | Material with a quality issue was used in contact lens production, so contact lenses may not meet quality and/or performance standards for the entirety of their labeled shelf life, and wearing these lenses may lead to temporary issues such as irritation, redness, or blurred vision. | Class II | Open, Classified | |
| Z-2680-2024 | Product Name: 25+TTLPL VPK 20000CPM BEV VAL Model/Catalog Number: 8065753106 Software Version: N/A Component: N/A | Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives. | Class II | Open, Classified | |
| Z-2679-2024 | Product Name: 25+ CMB PAK 10K CPM,V,WA 0.9 Model/Catalog Number: 8065752451 Software Version: N/A Component: N/A | Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives. | Class II | Open, Classified | |
| Z-2678-2024 | Product Name: 25+ CMB PAK 10K CPM,V,STD 0.9 Model/Catalog Number: 8065752450 Software Version: N/A Component: N/A | Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives. | Class II | Open, Classified | |
| Z-2677-2024 | Product Name: TOTAL PLUS,25+,10K VALVE WD Model/Catalog Number: 8065752438 Software Version: N/A Component: N/A | Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives. | Class II | Open, Classified | |
| Z-2676-2024 | Product Name: TOTAL PLUS,25+,10K VALVE STD Model/Catalog Number: 8065752437 Software Version: N/A Component: N/A | Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives. | Class II | Open, Classified | |
| Z-2675-2024 | Product Name: 25+ CMB PAK 7.5CPM,V,STD 0.9 Model/Catalog Number: 8065751767 Software Version: N/A Component: N/A | Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives. | Class II | Open, Classified | |
| Z-2674-2024 | Product Name: TOTALPLUS,25+ 7.5CPM VALV WD6 Model/Catalog Number: 8065751618 Software Version: N/A Component: N/A | Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives. | Class II | Open, Classified | |
| Z-2673-2024 | Product Name: TOTAL PLUS,25+ 7.5CPM VALVE Model/Catalog Number: 8065751617 Software Version: N/A Component: N/A | Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives. | Class II | Open, Classified | |
| Z-2672-2024 | Product Name: 25+ TOTALPLUSr CP PAK 20K CPM BWV .9 IU Model/Catalog Number: 8065000093 Software Version: N/A Component: N/A | Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives. | Class II | Open, Classified | |
| Z-2671-2024 | Product Name: 25+ TOTALPLUS CP PAK 20K CPM BV .9 IU Model/Catalog Number: 8065000095 Software Version: N/A Component: N/A | Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives. | Class II | Open, Classified |
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