Bausch & Lomb Incorporated
Greenville, SC, US
Bausch & Lomb Incorporated appears in FDA device records in Greenville, SC. FDA records list 131 510(k) clearances between and , 921 PMA records and 9 registered establishments. As of , FDA records show 156 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 Bausch & Lomb Incorporated 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.
- Alden Opticalenforcement report, recall
- Bausch & Lomb Inc Irbenforcement report, recall
- Bausch & Lomb Inc- Greenville Solutions Plantenforcement report, recall
- Bausch & Lomb Surgical, Inc.PMA, enforcement report, recall
- Bausch and Lomb, Inc.,510(k), PMA, enforcement report, recall
510(k) clearance history
Showing 50 of 131FDA records hold 131 510(k) clearances for Bausch & Lomb Incorporated between 1977 and 2026. The busiest year on record is 1986, with 9. The most recent is 2026, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1977 | 1 |
| 1978 | 4 |
| 1979 | 3 |
| 1981 | 1 |
| 1982 | 2 |
| 1983 | 1 |
| 1984 | 1 |
| 1985 | 4 |
| 1986 | 9 |
| 1987 | 1 |
| 1988 | 2 |
| 1989 | 2 |
| 1991 | 2 |
| 1992 | 3 |
| 1993 | 1 |
| 1994 | 3 |
| 1997 | 1 |
| 1998 | 6 |
| 1999 | 2 |
| 2000 | 5 |
| 2001 | 7 |
| 2002 | 6 |
| 2003 | 3 |
| 2004 | 4 |
| 2005 | 2 |
| 2006 | 4 |
| 2007 | 3 |
| 2008 | 5 |
| 2009 | 2 |
| 2010 | 1 |
| 2011 | 1 |
| 2012 | 5 |
| 2013 | 6 |
| 2014 | 4 |
| 2015 | 2 |
| 2016 | 3 |
| 2017 | 4 |
| 2018 | 3 |
| 2019 | 2 |
| 2020 | 1 |
| 2021 | 2 |
| 2022 | 1 |
| 2023 | 1 |
| 2024 | 3 |
| 2026 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K261264 | Stellaris Elite™ vision enhancement system; Posterior and Combined Procedure Pack(s): 23 ga. Posterior Elite™ Pack (SE5423); 23 ga. Bi-Blade™ Vitreous Cutter Posterior Stellaris Elite™ Pack (SE5423B); 25 ga. Posterior Elite™ Pack (SE5425); 25 ga. Bi-Blade™ Vitreous Cutter Posterior Stellaris Elite™ Pack (SE5425B); 27 ga. Bi-Blade™ Vitreous Cutter Posterior Stellaris Elite™ Pack (SE5427B); 23 ga. Bi-Blade™+ Vitreous Cutter Posterior Stellaris Elite™ Pack (SE5423BB+); 25 ga. Bi-Blade™+ | HQC | Substantially Equivalent | |
| K252052 | Stellaris Elite™ vision enhancement system (BL11145, BL14455, BL15455, SE14565, SE15565, SE14565E, SE15565E) | HQC | Substantially Equivalent | |
| K242389 | EyeGility™ Inserter for Preloaded enVista IOLs | MSS | Substantially Equivalent | |
| K240169 | Stellaris Elite vision enhancement system (BL11145, BL14455, BL15455) | HQC | Substantially Equivalent | |
| K232084 | Stellaris Elite vision enhancement system | HQC | Substantially Equivalent | |
| K220613 | Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens, Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for Astigmatism, and, Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for Presbyopia | LPL | Substantially Equivalent | |
| K222541 | Bausch + Lomb Preservative Free Lubricating and Rewetting Drops | LPN | Substantially Equivalent | |
| K202932 | ABT12 multi-purpose solution | LPN | Substantially Equivalent | |
| K210975 | Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for Presbyopia | LPL | Substantially Equivalent | |
| K200416 | Boston One Step Liquid Enzymatic Cleaner | MRC | Substantially Equivalent | |
| K192005 | Bausch + Lomb PreVue Inserter for enVista Preloaded | MSS | Substantially Equivalent | |
| K183167 | Boston ES (enflufocon A) Rigid Gas Permeable Contact Lens; Boston EO (enflufocon B) Rigid Gas Permeable Contact Lens; Boston XO (hexafocon A) Rigid Gas Permeable Contact Lens; Boston XO2 (hexafocon B) Rigid Gas Permeable Contact Lens | HQD | Substantially Equivalent | |
| K182249 | Ultra (samfilcon A) Multifocal for Astigmatism Contact Lens | LPL | Substantially Equivalent | |
| K181627 | Bausch + Lomb Boston SimplusMulti-Action Solution, Bausch + Lomb Boston One Step Liquid Enzymatic Cleaner | MRC | Substantially Equivalent | |
| K180319 | Bausch + Lomb Boston Advance Cleaner, Bausch + Lomb Boston Advance Conditioning Solution | MRC | Substantially Equivalent | |
| K173480 | Crystalsert Lens Delivery System | MSS | Substantially Equivalent | |
| K173089 | Bausch + Lomb Boston Original Cleaner, Bausch + Lomb Boston Original Conditioning Solutions | MRC | Substantially Equivalent | |
| K173365 | Bausch + Lomb Boston Scleral Lens Case | LRX | Substantially Equivalent | |
| K170483 | Bausch + Lomb Sensitive Eyes Plus Saline Solution | LPN | Substantially Equivalent | |
| K161819 | NNR06 Multi-Purpose Solution | LPN | Substantially Equivalent | |
| K161012 | Easy-Load Lens Delivery System | MSS | Substantially Equivalent | |
| K151918 | Biotrue ONEday with NaturMoist, Biotrue ONEday for Presbyopia with NaturMoist, Biotrue ONEday for Astigmatism with NaturMoist | LPL | Substantially Equivalent | |
| K151102 | Bausch + Lomb Injector System | MSS | Substantially Equivalent | |
| K143632 | Bausch + Lomb Biotrue ONEday for Astigmatism(nesofilcon A) Soft (hydrophilic) Contact Lens | LPL | Substantially Equivalent | |
| K133486 | STELLARIS PC VISION ENHANCEMENT SYSTEM | HQC | Substantially Equivalent | |
| K133242 | STELLARIS VISION ENHANCEMENT SYSTEM | HQC | Substantially Equivalent | |
| K131958 | BAUSCH & LOMB INJECTOR SYSTEM | MSS | Substantially Equivalent | |
| K133146 | BAUSCH + LUMB, VIS100 INJECTOR SYSTEM | MSS | Substantially Equivalent | |
| K132481 | EASY-LOAD LENS DELIVERY SYSTEM | MSS | Substantially Equivalent | |
| K132715 | BAUSCH + LOMB BIOTURE ONEDAY FOR PRESBYOPIA (NESOFILCON A) CONTACT LENS | LPL | Substantially Equivalent | |
| K132593 | CRYSTALSERT DELIVERY SYSTEM | MSS | Substantially Equivalent | |
| K131208 | BAUSCH + LOMB PROCOMFORT (SAMFILCON A) CONTACT LENS, BAUSCH + LOMB PROCOMFORT (SAMFILCON A) CONTACT LENS FOR PRESBYOPIA, | LPL | Substantially Equivalent | |
| K132216 | BAUSCH + LOMB PEROXICLEAR 3% HYDROGEN PEROXIDE CLEANING & DISINFECTING SOLUTION | LPN | Substantially Equivalent | |
| K123736 | CRYSTALSERT DELIVERY SYSTEM | MSS | Substantially Equivalent | |
| K122575 | BAUSCH & LOMB PUREVISION (BALAFILCON A) VISIBILITY TINTED CONTACT LENS, BAUSCH & LOMB PUREVISION TORIC (BALAFILCON A) VI | LPL | Substantially Equivalent | |
| K113852 | BAUSCH & LOMB IOL INJECTOR | MSS | Substantially Equivalent | |
| K113703 | BAUSCH + LOMB NESOFILCON A CONTACT LENS | LPL | Substantially Equivalent | |
| K112909 | OCD04 3% HYDROGEN PEROXIDE CLEANING AND DISINFECTING SOULTION | LPN | Substantially Equivalent | |
| K111877 | EZS05 CLEANING AND DISINFECTING SOLUTION, BAUSCH + LOMB EZS05 CLEANING AND DISINFECTING SOLUTION | LPN | Substantially Equivalent | |
| K112192 | NATURELLE DAILY DISPOSABLE (HILAFILCON B) COSMETICALLY TINTED CONTACT LENS | MVN | Substantially Equivalent | |
| K101325 | STELLARIS PC VISION ENHANCEMENT SYSTEM | HQC | Substantially Equivalent | |
| K083757 | BPZ02 MULTIPURPOSE SOLUTION | LYL | Substantially Equivalent | |
| K082473 | BAUSCH & LOMB STELLARIS MICROSURGICAL SYSTEM | HQC | Substantially Equivalent | |
| K082944 | CRYSTALSERT CRYSTALENS DELIVERY SYSTEM | MSS | Substantially Equivalent | |
| K082132 | BAUSCH & LOMB D4600A AIR EXCHANGE LINE PACK | HQC | Substantially Equivalent | |
| K080755 | SOFLENS DAILY DISPOSABLE TORIC (HILAFILCON B) VISIBILITY TINTED CONTACT LENS | MVN | Substantially Equivalent | |
| K073023 | STERILS SINGLE-USE I/A HANDPIECES | HQC | Substantially Equivalent | |
| K073184 | BOSTON RGP LENSES WET SHIPPED IN BOSTOM SIMPLUS MULTI-ACTION SOLUTION AND STORED FOR UP TO 30 DAYS | HQD | Substantially Equivalent | |
| K071266 | BOSTON X02 (HEXAFOCON B) RIGID GAS PERMEABLE CONTACT LENS | HQD | Substantially Equivalent | |
| K071043 | BOSTON XO (HEXAFOCON A), BOSTON EO (ENFLUFOCON B) AND BOSTON ES (ENFLUFOCON A) RIGID GAS PERMEABLE CONTACT LENSES | HQD | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1032500 | 1032500 | Bausch & Lomb Incorporated | 8507 PELHAM RD., GREENVILLE, SC 29615 US | 2026 | |
| 1119279 | 1119279 | Bausch & Lomb Incorporated | 21 PARK PLACE BLVD. NORTH, CLEARWATER, FL 33759 US | 2026 | |
| 1123818 | 1000305478 | Bausch & Lomb Incorporated | 1501 Graves Mill Rd, Lynchburg, VA 24502 US | 2026 | |
| 1281950 | 1281950 | Bausch & Lomb Incorporated | 100 RESEARCH DRIVE, WILMINGTON, MA 01887 US | 2026 | |
| 1313525 | 1317628 | Bausch & Lomb Incorporated | 1400 North Goodman Street, Rochester, NY 14609 US | 2026 | and 195 more, listed in full below |
| 1315522 | 1315522 | Bausch & Lomb Incorporated | 6 Lancaster Pkwy, Lancaster, NY 14086 US | 2026 | |
| 1920664 | 1920664 | Bausch & Lomb Incorporated | 3365 TREE CT. INDUSTRIAL BLVD., Saint Louis, MO 63122 US | 2026 | and 17 more, listed in full below |
| 1932180 | 1000119305 | Bausch & Lomb Incorporated | 499 SOVEREIGN CT., Manchester, MO 63011 US | 2026 | and 143 more, listed in full below |
| 3029990829 | 3029990829 | Bausch & Lomb Incorporated | Lilienthalstr. 16, 18, Eppelheim Baden-Wurttemberg 69214 DE | 2026 | and 10 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- HJOBiomicroscope, Slit-Lamp, Ac-Powered
- EQJBur, Ear, Nose And Throat
- GFFBur, Surgical, General & Plastic Surgery
- FGYCannula, Injection
- CATCannula, Nasal, Oxygen
- HMXCannula, Ophthalmic
- GEACannula, Surgical, General & Plastic Surgery
- GBXCatheter, Irrigation
- FZOChisel, Surgical, Manual
- FZSCurette, Surgical, General Use
- HLFDevice, Measuring, Lens Radius, Ophthalmic
- GDIDissector, Surgical, General & Plastic Surgery
- GEIElectrosurgical, Cutting & Coagulation & Accessories
- GEGElevator, Surgical, General & Plastic Surgery
- GENForceps, General & Plastic Surgery
- BWBForceps, Tube Introduction
- GWXFork, Tuning
- HLNGauge, Lens, Ophthalmic
- GDHGouge, Surgical, General & Plastic Surgery
- FZXGuide, Surgical, Instrument
- GDZHandle, Scalpel
- ESDHearing Aid, Air-Conduction, Prescription
- FHQHolder, Needle, Gastroenterologic
- GDGHook, Surgical, General & Plastic Surgery
- HBIIlluminator, Fiberoptic, Surgical Field
- HLMInstrument, Measuring, Lens, Ac-Powered
- DWSInstruments, Surgical, Cardiovascular
- EMFKnife, Surgical
- GFJMallet, Surgical, General & Plastic Surgery
- HMRMarker, Ocular
- HMQMarker, Sclera
- HKFMirror, Headband, Ophthalmic
- CAFNebulizer (Direct Patient Interface)
- GDMNeedle, Aspiration And Injection, Reusable
- FHRNeedle, Gastro-Urology
- GABNeedle, Suturing, Disposable
- GFIOsteotome, Manual
- GEXPowered Laser Surgical Instrument
- GXIProbe, Radiofrequency Lesion
- GACRasp, Surgical, General & Plastic Surgery
- HKORefractometer, Ophthalmic
- GADRetractor
- FFORetractor, Self-Retaining
- HNCSpecula, Ophthalmic
- EPYSpeculum, Ent
- FXESpeculum, Non-Illuminated
- HNBSpoon, Ophthalmic
- HNASpud, Ophthalmic
- HMFStand, Instrument, Ac-Powered, Ophthalmic
- GDTStaple, Removable (Skin)
- EIDSyringe, Restorative And Impression Material
- FTYTape, Measuring, Rulers And Calipers
- HKYTonometer, Manual
- HMZTrabeculotome
- HGLTransducer, Ultrasonic, Obstetric
- FSMTray, Surgical, Instrument
- BYYTube, Aspirating, Flexible, Connecting
- GAZTubing, Noninvasive
- BYXTubing, Pressure And Accessories
- EFSUnit, Oral Irrigation
Recall records
Showing 25 of 156| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2451-2025 | Akreos, SKU: AO60P0300. Akreos intraocular lenses | An off-power error was identified, which resulted in a diopter of 16, rather than the intended 3 diopter. Implantation of affected intraocular lens could result in functional visual impairment or reduction in visual acuity which could result in the need for optical or surgical correction. | Class III | Open, Classified | |
| Z-1680-2025 | Intraocular Lens. enVista Envy IOL, All models starting with EN; enVista Envy Toric IOL, All models starting with ETN. | In response to an increased number of reports of toxic anterior segment syndrome (TASS) in conjunction with implantation of enVista Aspire and enVista Envy IOLs, and certain enVista monofocal lenses in the U.S. | Class I | Open, Classified | |
| Z-1679-2025 | Intraocular lens. enVista Monofocal IOL, All models starting with EE; enVista Aspire IOL, All models starting with EA; enVista Monofocal Toric IOL, All models starting with ETE; enVista Aspire Toric IOL, All models starting with ETA; | In response to an increased number of reports of toxic anterior segment syndrome (TASS) in conjunction with implantation of enVista Aspire and enVista Envy IOLs, and certain enVista monofocal lenses in the U.S. | Class I | Open, Classified | |
| Z-0519-2021 | MX60ET (enhanced enVista Toric) enVista One-Piece Hydrophobic Acrylic Toric Model MX60ET - Product Usage: The lens is intended for placement in the capsular bag. | Product may be missing toric axis marks. | Class II | Terminated | |
| Z-2552-2020 | enVista one-piece hydrophobic acrylic toric intraocular lens, Bausch and Lomb - Product Usage: is indicated for primary implantation in the capsular bag of the eye in adult patients for visual correction of aphakia and corneal astigmatism following removal of a cataractous lens for improved uncorrected distance vision. | The toric axis marks were misaligned (from the expected position in relation to the haptics) on an implanted lens. | Class II | Terminated | |
| Z-0628-2019 | enVista One Piece Hydrophobic Acrylic Intraocular lens - Is indicated for primary implantation for the visual correction of aphakia in adult patients in whom the cataractous lens has been removed. The lens is intended for placement in the capsular bag. | Cosmetic imperfections on the surface of some lenses. | Class II | Terminated | |
| Z-3277-2018 | Bausch + Lomb Stellaris Elite Vision Enhancement System, 25 ga. Combined Wide-Field Elite Pack, REF SE5525WV (containing the Stellaris Elite 25 GA Vit Cutter, Model BL5628), packaged in sterile trays, 6 trays/shipper. | The back cap separates from the body of the vitrectomy cutter. | Class II | Terminated | |
| Z-3276-2018 | Bausch + Lomb Stellaris Elite Vision Enhancement System, 25 ga. Combined Mid-Field Elite Pack, REF SE5525MV (containing the Stellaris Elite 25 GA Vit Cutter, Model BL5628), packaged in sterile trays, 6 trays/shipper. | The back cap separates from the body of the vitrectomy cutter. | Class II | Terminated | |
| Z-3275-2018 | Bausch + Lomb Stellaris Elite Vision Enhancement System, 23 ga. Combined Wide-Field Elite Pack, REF SE5523WV (containing the Stellaris Elite 23 GA Vit Cutter, Model BL5627), packaged in sterile trays, 6 trays/shipper. | The back cap separates from the body of the vitrectomy cutter. | Class II | Terminated | |
| Z-3274-2018 | Bausch + Lomb Stellaris Elite Vision Enhancement System, 23 ga. Combined Mid-Field Elite Pack, REF SE5523MV (containing the Stellaris Elite 23 GA Vit Cutter, Model BL5627), packaged in sterile trays, 6 trays/shipper. | The back cap separates from the body of the vitrectomy cutter. | Class II | Terminated | |
| Z-3273-2018 | Bausch + Lomb Stellaris Elite Vision Enhancement System, 25 ga. Posterior Wide-Field Elite Pack, REF SE5425WV (containing the Stellaris Elite 25 GA Vit Cutter, Model BL5628), packaged in sterile trays, 6 trays/shipper. | The back cap separates from the body of the vitrectomy cutter. | Class II | Terminated | |
| Z-3272-2018 | Bausch + Lomb Stellaris Elite Vision Enhancement System, 25 ga. Posterior Mid-Field Elite Pack, REF SE5425MV (containing the Stellaris Elite 25 GA Vit Cutter, Model BL5628), packaged in sterile trays, 6 trays/shipper. | The back cap separates from the body of the vitrectomy cutter. | Class II | Terminated | |
| Z-3271-2018 | Bausch + Lomb Stellaris Elite 25 GA Vit Cutter, Model BL5628, 7500 cpm, packaged in sterile pouches, 6/shipper. | The back cap separates from the body of the vitrectomy cutter. | Class II | Terminated | |
| Z-3270-2018 | Bausch + Lomb Stellaris Elite Vision Enhancement System, 23 ga. Posterior Wide-Field Elite Pack, REF SE5423WV (containing the Stellaris Elite 23 GA Vit Cutter, Model BL5627), packaged in sterile trays, 6 trays/shipper. | The back cap separates from the body of the vitrectomy cutter. | Class II | Terminated | |
| Z-3269-2018 | Bausch + Lomb Stellaris Elite Vision Enhancement System, 23 ga. Posterior Mid-Field Elite Pack, REF SE5423MV (containing the Stellaris Elite 23 GA Vit Cutter, Model BL5627), packaged in sterile trays, 6 trays/shipper. | The back cap separates from the body of the vitrectomy cutter. | Class II | Terminated | |
| Z-3268-2018 | Bausch + Lomb Stellaris Elite 23 GA Vit Cutter, Model BL5627, 7500 cpm, packaged in sterile pouches, 6/shipper. | The back cap separates from the body of the vitrectomy cutter. | Class II | Terminated | |
| Z-3267-2018 | Bausch + Lomb Stellaris Elite Vision Enhancement System, 20 ga. Posterior Wide-Field Elite Pack, REF SE5420W (containing the Stellaris Elite 20 GA Vit Cutter, Model BL5626), packaged in sterile trays, 6 trays/shipper. | The back cap separates from the body of the vitrectomy cutter. | Class II | Terminated | |
| Z-3266-2018 | Bausch + Lomb Stellaris Elite Vision Enhancement System, 20 ga. Posterior Mid-Field Elite Pack, REF SE5420M (containing the Stellaris Elite 20 GA Vit Cutter, Model BL5626), packaged in sterile trays, 6 trays/shipper. | The back cap separates from the body of the vitrectomy cutter. | Class II | Terminated | |
| Z-3265-2018 | Bausch + Lomb Stellaris Elite 20 GA Vit Cutter, Model BL5626, 7500 cpm, packaged in sterile pouches, 6/shipper. | The back cap separates from the body of the vitrectomy cutter. | Class II | Terminated | |
| Z-2982-2018 | Zen RC Toric-Gas permeable contact lenses for Daily Wear in a 10-cc polycarbonate vial (Rx)as follows: Zen RC TPC (Toric Peripheral Curve) Zen RC FT (Front Toric Optics) Catalog Number: AOZNT Zenlens Toric - Zenlens contact lenses are indicated for daily wear for the correction of refractive arnetropia (myopia, hyperopia, and astigmatism) in aphakic and nonaphakic persons with non-diseased eyes. | Vials labeled for the prescriptions contained incorrect lenses | Class III | Terminated | |
| Z-2981-2018 | Zenlens Toric-Gas Permeable Contact lenses for Daily Wear in a 10-cc polycarbonate vial (Rx) as follows: Zenlens FT(Front Toric); Zenlens Toric-Zenlens FT + MV (Front Toric+Microvault); Zenlens TPC-(Toric Peripheral Curve); Zenlens TPC + FT- (Toric Peripheral Curve + FrontToric) Zenlens TPC + MV- (Toric Peripheral Curve+Microvault). Catalog Number: AOZNT Zenlens Toric - Zenlens contact lenses are indicated for daily wear for the correction of refractive arnetropia (myopia, hyperopia, and astigmatism) in aphakic and nonaphakic persons with non-diseased eyes. | Vials labeled for the prescriptions contained incorrect lenses | Class III | Terminated | |
| Z-0991-2018 | ASTERA Multifocal Toric Daily Wear Soft contact; Catalog Number: AOAMT54 Product Usage: The ALDEN TORIC LENS for daily wear is indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with refractive ametropia (myopia or hyperopia) and/or possesses refractive astigmatism not exceeding 10 Diopters. | Contact lenses lack sterility assurance. | Class II | Terminated | |
| Z-0990-2018 | Alden HP59 Toric Daily Wear Soft contact; Catalog Number: AOHPT59 Product Usage: The ALDEN TORIC LENS for daily wear is indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with refractive ametropia (myopia or hyperopia) and/or possesses refractive astigmatism not exceeding 10 Diopters. | Contact lenses lack sterility assurance. | Class II | Terminated | |
| Z-0989-2018 | Alden Classic 55 Toric Daily Wear Soft contact; Catalog Number: AOCLT55 Product Usage: The ALDEN TORIC LENS for daily wear is indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with refractive ametropia (myopia or hyperopia) and/or possesses refractive astigmatism not exceeding 10 Diopters. | Contact lenses lack sterility assurance. | Class II | Terminated | |
| Z-0988-2018 | Alden HP54 Toric Daily Wear Soft contact; Catalog Number: AOHPT54 Product Usage: The ALDEN TORIC LENS for daily wear is indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with refractive ametropia (myopia or hyperopia) and/or possesses refractive astigmatism not exceeding 10 Diopters. | Contact lenses lack sterility assurance. | Class II | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain