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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: —
Website: —
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PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: —
DUNS Number: —

Catalogue (314)

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Device	Model / Reference	Registries	Class	Status
Viscous Fluid Injector System Module (cx5700)	K993039	FDA 510(k)	Class II	Active
Spectrophotometer	K781138	FDA 510(k)	Class I	Active
Cybercases By Bausch & Lomb	K013232	FDA 510(k)	Class II	Active
Millennium Microsurgical System And Peristaltic Phaco Pack	K033941	FDA 510(k)	Class II	Active
Fisher Spectrophotometer	K780902	FDA 510(k)	Class I	Active
Bausch & Lomb Injector System	K131958	FDA 510(k)	Class I	Active
Soundchoice With Variable Slope	K926476	FDA 510(k)	Class I	Active
Stellaris Vision Enhancement System	K133242	FDA 510(k)	Class II	Active
Oxycor (balafilcon A) Visibility Tinted Contact Lens	K972454	FDA 510(k)	Class II	Active
Bausch & Lomb Premier 90 (balafilcon A) Contact Lens	K944895	FDA 510(k)	Class II	Active
Naturelle Daily Disposable (hilafilcon B) Cosmetically Tinted Contact Lens	K112192	FDA 510(k)	Class II	Active
Bausch & Lomb Stellaris Microsurgical System	K082473	FDA 510(k)	Class II	Active
Renu Multiplus Multi-Purpose Disinfecting Solution	K002823	FDA 510(k)	Class II	Active
Bausch & Lomb Accu-Chart 3 Acuity Projector	K862519	FDA 510(k)	Class I	Active
Bausch & Lomb Renu Multi-Purpose Solution	K982775	FDA 510(k)	Class II	Active
Bausch & Lomb Medalist 66 (alphafilcon A) Visibility Tinted Contact Lens	K941370	FDA 510(k)	Class II	Active
Bausch & Lomb Soflens Multifocal (polymacon) Visibility Tinted Contact Lens	K020927	FDA 510(k)	Class II	Active
Bausch & Lomb Renu 1 Step Daily Protein Remover	K000247	FDA 510(k)	Class II	Active
Boston Xo (hexafocon A), Boston Eo (enflufocon B) And Boston Es (enflufocon A) Rigid Gas Permeable Contact Lenses	K071043	FDA 510(k)	Class II	Active
Purevision Multi-Focal (balafilcon A) Visibility Tinted Contact Lens	K050948	FDA 510(k)	Class II	Active
Bausch & Lomb Multi-Purpose Solution Nrc03	K031646	FDA 510(k)	Class II	Active
Bausch & Lomb Phoenix (hilafilcon A) Visibility Tinted Contact Lens	K983894	FDA 510(k)	Class II	Active
Clinical Analyzer System	K780903	FDA 510(k)	Class I	Active
B & L Ophthalmic Instrument Stand	K791104	FDA 510(k)	Class I	Active
Stellaris Elite vision enhancement system	K232084	FDA 510(k)	Class II	Active
Bausch + Lomb Injector System	K151102	FDA 510(k)	Class I	Active
Entry Site Alignment System Model # Cx9626	K012435	FDA 510(k)	Class I	Active
Ngdi (next Generation Diagnostic Instrument)	K040913	FDA 510(k)	Class II	Active
Bausch & Lomb Renu Rewetting & Lubricating Drops	K874364	FDA 510(k)	Class II	Active
Venturi Phaco Pack	K033653	FDA 510(k)	Class II	Active
Interjet(tm) Gingival Care Instrument	K921999	FDA 510(k)	Class I	Active
Bio-Cor Ext Collagen Corneal Shield	K874225	FDA 510(k)	Class I	Active
Boston Rgp Lenses Wet Shipped In Bostom Simplus Multi-Action Solution And Stored For Up To 30 Days	K073184	FDA 510(k)	Class II	Active
Bausch & Lomb Lens Carrying Case	K854968	FDA 510(k)	U	Active
Bausch + Lomb Procomfort (samfilcon A) Contact Lens, Bausch + Lomb Procomfort (samfilcon A) Contact Lens For Presbyopia,	K131208	FDA 510(k)	Class II	Active
Spectronic 501 & 601 - Clinical Spectrophotometer	K850709	FDA 510(k)	Class I	Active
Spectronic 1001 - Clinical Spectrophotometer	K850708	FDA 510(k)	Class I	Active
Bpz02 Multipurpose Solution	K083757	FDA 510(k)	Class II	Active
Renu Multiplus Lubricating & Rewetting Drops	K980591	FDA 510(k)	Class II	Active
Bausch & Lomb Ngx Microsurgical System	K063331	FDA 510(k)	Class II	Active
Projector, Accu-Chart Acuity	K781658	FDA 510(k)	Class I	Active
Soflens(tm) One Day Disposable (hilafilcon A) Visibility Tinted Contact Lens	K974780	FDA 510(k)	Class II	Active
Ocd04 3% Hydrogen Peroxide Cleaning And Disinfecting Soultion	K112909	FDA 510(k)	Class II	Active
Bausch & Lomb Gr-3 Refractor	K862521	FDA 510(k)	Class I	Active
Proview Eye Pressure Monitor	K011199	FDA 510(k)	Class II	Active
Bausch & Lomb Soflens One Day Disposable (hilafilcon A) Visibility Tinted Contact	K011718	FDA 510(k)	Class II	Active
Akreos Single Use Insertion Device, Model Ai-28	K063694	FDA 510(k)	Class I	Active
Bausch & Lomb 2-Week (hilafilcon B) Visibility Tinted Contact Lenses	K994125	FDA 510(k)	Class II	Active
Easy-Load Lens Delivery System	K132481	FDA 510(k)	Class I	Active
Bio-Cor Ii Collagen Corneal Shield	K874224	FDA 510(k)	Class I	Active

Related Companies

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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.