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Bausch & Lomb, Inc.

Last updated September 17, 2026

What Bausch & Lomb, Inc. makes

Bausch & Lomb, Inc. manufactures single-use ophthalmic surgical instruments, including irrigation/aspiration cannulas, soft-tissue manipulation forceps, and vitrectomy handpieces. Their portfolio also includes reusable suturing needle holders and posterior-chamber intraocular lenses (IOLs) for cataract surgery, as well as electrosurgical handpieces and surgical procedure kits for open and minimally invasive procedures. Specific products include toric IOLs, lid specula, and specialized cannulas for phacoemulsification and membrane manipulation.

The company’s devices are regulated under FDA classifications ranging from Class I to Class III and unclassified (U), with authorisations granted through 510(k), PMA, and UDI registrations. Products are listed in the FDA’s regulatory databases, and the manufacturer operates from the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What types of medical devices does Bausch & Lomb, Inc. primarily manufacture?

Bausch & Lomb, Inc. specializes in ophthalmic surgical devices, focusing on single-use instruments like irrigation/aspiration cannulas, soft-tissue manipulation forceps, and vitrectomy handpieces. Their portfolio also includes reusable suturing needle holders and posterior-chamber intraocular lenses (IOLs) for cataract surgery, as well as electrosurgical handpieces and surgical kits for both open and minimally invasive procedures. These devices are designed for procedures such as cataract removal, membrane manipulation, and fluid/gas management during vitreoretinal surgery.

Where is Bausch & Lomb, Inc. based, and how does that affect its regulatory oversight?

Bausch & Lomb, Inc. is based in the United States, which means its devices fall under FDA regulatory jurisdiction. The FDA classifies their products across multiple tiers—Class I (low-risk), Class II (moderate-risk with special controls), Class III (high-risk requiring PMA), and unclassified (U)—depending on their intended use and potential risks. This classification determines the regulatory pathway, such as 510(k) clearance for lower-risk devices or PMA submission for higher-risk ones like certain IOLs.

Which regulatory registries or databases list Bausch & Lomb’s devices?

Bausch & Lomb’s devices are listed in the FDA’s regulatory databases, including the 510(k) Premarket Notification Database for cleared devices, the Premarket Approval (PMA) Database for high-risk products like some intraocular lenses, and the Unique Device Identifier (UDI) Database for traceability. These registries ensure transparency in device authorisation status and compliance with U.S. regulations.

How are Bausch & Lomb’s devices classified by the FDA, and why does this matter?

The FDA classifies Bausch & Lomb’s devices into Class I, II, III, or unclassified (U) based on risk levels and procedural contexts. For example, reusable suturing needle holders may fall under Class II due to sterility and surgical precision requirements, while posterior-chamber IOLs could be Class III due to their direct implantation into the eye. This classification dictates the regulatory pathway—e.g., 510(k) for Class II or PMA for Class III—ensuring appropriate scrutiny proportional to the device’s risk profile and patient impact.

What distinguishes Bausch & Lomb’s single-use ophthalmic instruments from reusable ones in their portfolio?

Bausch & Lomb’s single-use instruments, such as irrigation cannulas or vitrectomy handpieces, are designed for one-time surgical use to minimize infection risks and reduce sterilization burdens. In contrast, their reusable devices—like the Barraquer Needle Holder—are engineered for durability, repeated sterilization, and precision in suturing tasks. The distinction reflects regulatory considerations (e.g., single-use often simplifies Class I/II pathways) and clinical needs, where sterility and contamination control are critical in ophthalmic surgery.

AI-generated from registry data and not verified by a human reviewer.

Information

Country: US
Address: —
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EUDAMED SRN: —
FDA FEI Number: —
DUNS Number: —

Catalogue (314)

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Device	Model / Reference	Registries	Class	Status
Bausch + Lumb, Vis100 Injector System	K133146	FDA 510(k)	Class I	Active
Soflens One Day Plus Disposable (hilafilcon B) Visibility Tinted Contact Lens	K061157	FDA 510(k)	Class II	Active
Millennium Microsurgical System	K022760	FDA 510(k)	Class II	Active
Soundchoice K-Amp	K923735	FDA 510(k)	Class I	Active
Crystalsert Delivery System	K123736	FDA 510(k)	Class I	Active
Boston X02 (hexafocon B) Rigid Gas Permeable Contact Lens	K071266	FDA 510(k)	Class II	Active
Spectronic 2000 Spectrophotometer	K850767	FDA 510(k)	Class I	Active
Ezs05 Cleaning And Disinfecting Solution, Bausch + Lomb Ezs05 Cleaning And Disinfecting Solution	K111877	FDA 510(k)	Class II	Active
I.v.e. Refraction System	K812896	FDA 510(k)	Class I	Active
Interplak Home Plaque Removal Instrument	K935561	FDA 510(k)	Class I	Active
Renu Multiplus Multi-Purpose Solution	K974723	FDA 510(k)	Class II	Active
Maxsight (polymacon) Sport-Tinted Contact Lens	K050157	FDA 510(k)	Class II	Active
Bausch & Lomb Csl-1000 Slit Lamp	K862515	FDA 510(k)	Class II	Active
Bausch + Lomb PreVue Inserter for enVista Preloaded	K192005	FDA 510(k)	Class I	Active
Stellaris Elite vision enhancement system	K170052	FDA 510(k)	Class II	Active
Bausch & Lomb Renu Effervescent Enzymatic Contact Lens Cleaner	K983225	FDA 510(k)	Class II	Active
Phaco Chop Needles	K041998	FDA 510(k)	Class II	Active
Sterils Single-Use I/A Handpieces	K073023	FDA 510(k)	Class II	Active
Bausch & Lomb Sterile All Purpose Solu	K820511	FDA 510(k)	U	Active
Bausch & Lomb2 Sensitive Eyes Multi-Purpose Solution	K973921	FDA 510(k)	Class II	Active
Stellaris Pc Vision Enhancement System	K101325	FDA 510(k)	Class II	Active
Stellaris Pc Vision Enhancement System	K133486	FDA 510(k)	Class II	Active
Yagmaster Nd:yag Op Laser	P850091	FDA PMA	Class III	Active
Lincoff-Design Scleral Buckling Balloon Catheter	P820009	FDA PMA	Class III	Active
Sensitive Eyes Chemical Disinfectant	P840020	FDA PMA	Class II	Active
enVista Envy™ hydrophobic acrylic intraocular lens (IOL), enVista Envy™ toric hydrophobic acrylic intraocular lens (IOL)	P240005	FDA PMA	Class III	Active
B&L Sensitive Eyes(tm) Saline/Cleaning Solution	P850036	FDA PMA	Class II	Active
Hypo-Care Sterile Saline Spray	P860033	FDA PMA	Class II	Active
Hydroview Composite Hygrogel Foldable Ultraviolet-Absorbing Posterior Chamber Intraocular (iol)	P990014	FDA PMA	Class III	Active
B&L Therma-Zyme, Fizziclean	P850093	FDA PMA	Class II	Active
Tennant(tm) & Kelman(tm) Type Ii	P800016	FDA PMA	Class II	Active
Model 91-50 Iol	P820044	FDA PMA	Class III	Active
B&L 58(tm) (etafilcona) Contact Lens	P850039	FDA PMA	Class II	Active
Bausch & Lomb Soflens Toric (alphafilcon A) Soft Contact Lenses	P960022	FDA PMA	Class III	Active
B&L(r) (amefocon A) Oxygen Permeable Lens	P830050	FDA PMA	U	Active
0ensitive Eyes(tm) Saline & Cleaning Solution	P820031	FDA PMA	Class II	Active
Anterior Chamber Intraocular Lenses	P870013	FDA PMA	Class III	Active
B&L Sensitive Eyes(tm) Daily Cleaner	P830013	FDA PMA	Class II	Active
Model C11ub Ultraviolet-Absorbing Silicone Posterior Chamber Intraocular Lens	P910058	FDA PMA	Class III	Active
Toric And Optima (hefilcon B) Contact Lenses	N17676	FDA PMA	Class II	Active
Silsoft (elastofilcon A) Contact Lenses	P850068	FDA PMA	U	Active
One-Piece Posterior Chamber Intraocular Lenses	P870073	FDA PMA	Class III	Active
Crystalens Model At-45 Accommodating Intraocular Lens	P030002	FDA PMA	Class III	Active
Akreos Intraocular Lens	P060022	FDA PMA	Class III	Active
PureVision (balafilcon A) Visibility Tinted Contact Lens	K122575	FDA PMA	Class III	Active
Bausch + Lomb Ultra (samfilcon A) Visibility Tinted Soft (hydrophilic) Contact Lenses	P170035	FDA PMA	Class III	Active
Boston Equalens (itafluorofocon A) Rigid Gas Permeable Contact Lens, Equalens 2 (oprifocon A) Rigid Gas Permearable Lens	K013762	FDA PMA	Class III	Active
Ocucoat	P860047	FDA PMA	Class III	Active
Li61ao Lens	P910061	FDA PMA	Class III	Active
Polymethylmetha-Crylate (pmma) Intraocular Lenses (iols)	P860002	FDA PMA	Class III	Active

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FDA Recalls (78)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Bausch & Lomb, Inc. has 78 FDA recall records initiated between November 26, 2002, and August 8, 2018, all marked as terminated. The reasons cited include deviations in dye formulation, reports of microbial infections, incorrect refractive power in lenses, misprinted usage instructions, shelf-life specification failures, endotoxin contamination, recalibration needs for surgical modules, software malfunctions, and potential sterility or overheating issues in packaging or components.

AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.

Date	Recall No.	Class	Status	Reason
Aug 8, 2018	Z-3277-2018	—	terminated	The back cap separates from the body of the vitrectomy cutter.
Aug 8, 2018	Z-3271-2018	—	terminated	The back cap separates from the body of the vitrectomy cutter.
Aug 8, 2018	Z-3269-2018	—	terminated	The back cap separates from the body of the vitrectomy cutter.
Aug 8, 2018	Z-3266-2018	—	terminated	The back cap separates from the body of the vitrectomy cutter.
Aug 8, 2018	Z-3267-2018	—	terminated	The back cap separates from the body of the vitrectomy cutter.
Aug 8, 2018	Z-3265-2018	—	terminated	The back cap separates from the body of the vitrectomy cutter.
Aug 8, 2018	Z-3273-2018	—	terminated	The back cap separates from the body of the vitrectomy cutter.
Aug 8, 2018	Z-3268-2018	—	terminated	The back cap separates from the body of the vitrectomy cutter.
Aug 8, 2018	Z-3275-2018	—	terminated	The back cap separates from the body of the vitrectomy cutter.
Aug 8, 2018	Z-3274-2018	—	terminated	The back cap separates from the body of the vitrectomy cutter.
Aug 8, 2018	Z-3270-2018	—	terminated	The back cap separates from the body of the vitrectomy cutter.
Aug 8, 2018	Z-3272-2018	—	terminated	The back cap separates from the body of the vitrectomy cutter.
Aug 8, 2018	Z-3276-2018	—	terminated	The back cap separates from the body of the vitrectomy cutter.
Oct 12, 2016	Z-0983-2017	—	terminated	According to firm ( Bausch & Lomb, Inc. ) on June 17, 2016 a packaging operator notified his supervisor he had not placed the operating instruction into the last repackaging of SKU 0816 C (Pterygium Burr Medium Diamond). Further investigation found that repackaged Algerbrush-II and its accessories from April 30, 2012 to present, contained out of date operating instruction. Therefore Bausch & Lomb is proposing a Field Correction to provide customer purchasing product from April 30, 2012 to June 20, 2016 with the current operating instruction.
Nov 4, 2014	Z-0862-2015	—	terminated	A software anomaly was identified where the system may automatically transition from "Standby" to "Ready to Fire" state while in surgical use.
Nov 4, 2014	Z-0864-2015	—	terminated	A software anomaly was identified where the system may automatically transition from "Standby" to "Ready to Fire" state while in surgical use.
Nov 4, 2014	Z-0863-2015	—	terminated	A software anomaly was identified where the system may automatically transition from "Standby" to "Ready to Fire" state while in surgical use.
Aug 31, 2012	Z-0593-2013	—	terminated	Posterior fluidics modules installed in the system may need to be recalibrated.
Jul 27, 2011	Z-3090-2011	—	terminated	The aspiration channel on the affected vacuum cassettes may be blocked due to a molding malfunction
Jul 27, 2011	Z-3088-2011	—	terminated	The aspiration channel on the affected vacuum cassettes may be blocked due to a molding malfunction
Jul 27, 2011	Z-3089-2011	—	terminated	The aspiration channel on the affected vacuum cassettes may be blocked due to a molding malfunction
Jul 27, 2011	Z-3087-2011	—	terminated	The aspiration channel on the affected vacuum cassettes may be blocked due to a molding malfunction
Jun 30, 2011	Z-3042-2011	—	terminated	Muti-purpose solution bottles, lot GC1107 were packaged in a carton that was marked with an incorrect lot code and expiration date.
Dec 22, 2010	Z-1026-2011	—	terminated	There is a potential for some packages to not meet sterility requirements.
Dec 22, 2010	Z-1025-2011	—	terminated	There is a potential for some packages to not meet sterility requirements.
Apr 20, 2010	Z-1705-2010	—	terminated	The amount of D&C #6 Dye added to the formulation exceeded specified amounts.
Jan 15, 2010	Z-1664-2010	—	terminated	The AC power cords used on these products are subject to an FDA Alert -- Safety Investigation of Certain Medical Device Power Cords: Initial Communication, Date Issued: October 19, 2009.
Jan 15, 2010	Z-1663-2010	—	terminated	The AC power cords used on these products are subject to an FDA Alert -- Safety Investigation of Certain Medical Device Power Cords: Initial Communication, Date Issued: October 19, 2009.
Jan 8, 2010	Z-1713-2010	—	terminated	Users may incorrectly assemble the plastic needle wrench to the phacoemulsification needle resulting in the generation of plastic particulate
Jan 8, 2010	Z-1712-2010	—	terminated	Users may incorrectly assemble the plastic needle wrench to the phacoemulsification needle resulting in the generation of plastic particulate
Jan 8, 2010	Z-1715-2010	—	terminated	Users may incorrectly assemble the plastic needle wrench to the phacoemulsification needle resulting in the generation of plastic particulate
Jan 8, 2010	Z-1729-2010	—	terminated	Users may incorrectly assemble the plastic needle wrench to the phacoemulsification needle resulting in the generation of plastic particulate
Jan 8, 2010	Z-1710-2010	—	terminated	Users may incorrectly assemble the plastic needle wrench to the phacoemulsification needle resulting in the generation of plastic particulate
Jan 8, 2010	Z-1724-2010	—	terminated	Users may incorrectly assemble the plastic needle wrench to the phacoemulsification needle resulting in the generation of plastic particulate
Jan 8, 2010	Z-1722-2010	—	terminated	Users may incorrectly assemble the plastic needle wrench to the phacoemulsification needle resulting in the generation of plastic particulate
Jan 8, 2010	Z-1708-2010	—	terminated	Users may incorrectly assemble the plastic needle wrench to the phacoemulsification needle resulting in the generation of plastic particulate
Jan 8, 2010	Z-1709-2010	—	terminated	Users may incorrectly assemble the plastic needle wrench to the phacoemulsification needle resulting in the generation of plastic particulate
Jan 8, 2010	Z-1721-2010	—	terminated	Users may incorrectly assemble the plastic needle wrench to the phacoemulsification needle resulting in the generation of plastic particulate
Jan 8, 2010	Z-1723-2010	—	terminated	Users may incorrectly assemble the plastic needle wrench to the phacoemulsification needle resulting in the generation of plastic particulate
Jan 8, 2010	Z-1714-2010	—	terminated	Users may incorrectly assemble the plastic needle wrench to the phacoemulsification needle resulting in the generation of plastic particulate
Jan 8, 2010	Z-1717-2010	—	terminated	Users may incorrectly assemble the plastic needle wrench to the phacoemulsification needle resulting in the generation of plastic particulate
Jan 8, 2010	Z-1718-2010	—	terminated	Users may incorrectly assemble the plastic needle wrench to the phacoemulsification needle resulting in the generation of plastic particulate
Jan 8, 2010	Z-1725-2010	—	terminated	Users may incorrectly assemble the plastic needle wrench to the phacoemulsification needle resulting in the generation of plastic particulate
Jan 8, 2010	Z-1726-2010	—	terminated	Users may incorrectly assemble the plastic needle wrench to the phacoemulsification needle resulting in the generation of plastic particulate
Jan 8, 2010	Z-1716-2010	—	terminated	Users may incorrectly assemble the plastic needle wrench to the phacoemulsification needle resulting in the generation of plastic particulate
Jan 8, 2010	Z-1728-2010	—	terminated	Users may incorrectly assemble the plastic needle wrench to the phacoemulsification needle resulting in the generation of plastic particulate
Jan 8, 2010	Z-1730-2010	—	terminated	Users may incorrectly assemble the plastic needle wrench to the phacoemulsification needle resulting in the generation of plastic particulate
Jan 8, 2010	Z-1719-2010	—	terminated	Users may incorrectly assemble the plastic needle wrench to the phacoemulsification needle resulting in the generation of plastic particulate
Jan 8, 2010	Z-1727-2010	—	terminated	Users may incorrectly assemble the plastic needle wrench to the phacoemulsification needle resulting in the generation of plastic particulate
Jan 8, 2010	Z-1720-2010	—	terminated	Users may incorrectly assemble the plastic needle wrench to the phacoemulsification needle resulting in the generation of plastic particulate
Jan 8, 2010	Z-1711-2010	—	terminated	Users may incorrectly assemble the plastic needle wrench to the phacoemulsification needle resulting in the generation of plastic particulate
Nov 19, 2009	Z-0591-2010	—	terminated	Bausch & Lomb Incorporated, Rochester, NY is recalling their Silicone L161SE Intraocular Lens Lot 4916928 (23.5D) after receiving three customer complaints for what appears to be opacification of the intraocular lens. The opacification occurred within one week of implantation. In each reported case the surgeon explanted the lens.
Oct 30, 2009	Z-0553-2010	—	terminated	The product failed to meet Out of Specification shelf life at the 9 months time point. This could result in increased risk of an ocular infection, especially in the presence of other contributing or risk factors.
Aug 17, 2009	Z-0159-2010	—	terminated	During routine testing the product failed to meet shelf life specifications.
Jun 30, 2009	Z-1735-2009	—	terminated	The product failed to meet one of the shelf life specifications at the end of the expiry period.
Dec 8, 2008	Z-1911-2009	—	terminated	Affected lenses were inadvertently shipped to Bausch & Lomb's European Logistics Center (ELC) prior to release authorization. Initial testing indicated the product did not meet release criteria for endotoxin limits.
Apr 23, 2008	Z-0103-2009	—	terminated	The plastic tip on the drive shaft may come off the shaft and cause the blade to stop oscillating.
Apr 23, 2008	Z-0104-2009	—	terminated	The plastic tip on the drive shaft may come off the shaft and cause the blade to stop oscillating.
Mar 26, 2008	Z-2049-2008	—	terminated	The directions for use are printed with the incorrect symbols to indicate the product is packaged as sterile and nonreusable
Mar 26, 2008	Z-2051-2008	—	terminated	The directions for use are printed with the incorrect symbols to indicate the product is packaged as sterile and nonreusable
Mar 26, 2008	Z-2046-2008	—	terminated	The directions for use are printed with the incorrect symbols to indicate the product is packaged as sterile and nonreusable
Mar 26, 2008	Z-2050-2008	—	terminated	The directions for use are printed with the incorrect symbols to indicate the product is packaged as sterile and nonreusable
Mar 26, 2008	Z-2045-2008	—	terminated	The directions for use are printed with the incorrect symbols to indicate the product is packaged as sterile and nonreusable
Mar 26, 2008	Z-2048-2008	—	terminated	The directions for use are printed with the incorrect symbols to indicate the product is packaged as sterile and nonreusable
Mar 26, 2008	Z-2047-2008	—	terminated	The directions for use are printed with the incorrect symbols to indicate the product is packaged as sterile and nonreusable
Mar 26, 2008	Z-2044-2008	—	terminated	The directions for use are printed with the incorrect symbols to indicate the product is packaged as sterile and nonreusable
Mar 26, 2008	Z-2052-2008	—	terminated	The directions for use are printed with the incorrect symbols to indicate the product is packaged as sterile and nonreusable
Jun 8, 2007	Z-1022-2007	—	terminated	Reports have been received of stromal incursions after use of the product.
Jun 8, 2007	Z-1021-2007	—	terminated	Reports have been received of stromal incursions after use of the product.
Mar 5, 2007	Z-0715-2007	—	terminated	A higher than expected amount of trace iron in some bottles of finished product that over time affects the product's stability and color.
Feb 9, 2007	Z-0766-2007	—	terminated	The cutter probe tip breaks during use.
Feb 9, 2007	Z-0765-2007	—	terminated	The cutter probe tip breaks during use.
Dec 14, 2006	Z-0496-2007	—	terminated	The cutter tip could break during a procedure
Dec 14, 2006	Z-0495-2007	—	terminated	The cutter tip could break during a procedure
Apr 13, 2006	Z-1201-06	—	terminated	Reports of Fusarium Infections among contact lens wearers.
Feb 4, 2005	Z-0544-05	—	terminated	Portion of lot contains lenses with incorrect refractive power.
Nov 10, 2003	Z-0264-04	—	terminated	The CX9625 Light Pipe connector may overheat; this condition could result in the plastic connector that plugs into the Millennium Microsurgical System to malfunction.
Nov 26, 2002	Z-0348-03	—	terminated	Lenses labeled as -2.25 diopter contain -0.75 diopter lenses.