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Bausch & Lomb Incorporated

United States·US-MF-000001029

Last updated September 17, 2026

What Bausch & Lomb Incorporated makes

Bausch & Lomb Incorporated manufactures posterior-chamber intraocular lenses for pseudophakic patients, reusable ophthalmic instruments like soft-tissue manipulation forceps, corneal scissors, and suction cannulas for surgical and emergency use. Their portfolio also includes reusable middle ear tools such as chisels and picks, as well as reusable ophthalmic irrigation, infusion, and aspiration cannulas. Additionally, they produce intraocular retractors for surgical procedures.

The company’s devices are classified under FDA categories including Class I, Class II, Class IIa, Class III, and Class U, with listings in the EU’s eudamed registry and the FDA’s Unique Device Identifier (UDI) database. The manufacturer is based in 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 Incorporated primarily manufacture?

Bausch & Lomb Incorporated specializes in ophthalmic and otologic devices. Their portfolio includes posterior-chamber intraocular lenses for pseudophakic patients, reusable surgical instruments like soft-tissue manipulation forceps, corneal scissors, and suction cannulas for both surgical and emergency use. They also produce reusable middle ear tools such as chisels and picks, as well as reusable ophthalmic irrigation, infusion, and aspiration cannulas. Additionally, they manufacture intraocular retractors for surgical procedures.

Where is Bausch & Lomb Incorporated based, and how does that affect its regulatory landscape?

Bausch & Lomb Incorporated is based in the United States, which means its devices must comply with FDA regulations. The company’s products are classified under various FDA categories, including Class I, Class II, Class IIa, Class III, and Class U, reflecting differing levels of regulatory oversight depending on the device’s risk profile. This classification determines the regulatory pathway and documentation requirements for each product.

Which regulatory registries list Bausch & Lomb Incorporated’s devices?

Bausch & Lomb Incorporated’s devices are listed in two key regulatory registries: the European Union’s eudamed database, which tracks medical devices authorized for the EU market, and the FDA’s Unique Device Identifier (UDI) database, which catalogs devices cleared or approved for the US market. These registries ensure transparency and traceability for regulatory authorities and healthcare providers.

How are Bausch & Lomb Incorporated’s devices classified under FDA regulations?

Bausch & Lomb Incorporated’s devices are classified into multiple FDA categories based on their risk levels: Class I (low-risk, general controls), Class II (moderate-risk, requires special controls), Class IIa (a subset of Class II with additional regulatory scrutiny), Class III (high-risk, requires premarket approval), and Class U (unclassified, pending or exempt from classification). The classification determines the regulatory pathway, such as 510(k) clearance for Class II or PMA submission for Class III devices.

What distinguishes Bausch & Lomb Incorporated’s reusable surgical instruments from their disposable contact lenses?

Bausch & Lomb Incorporated’s reusable surgical instruments—such as ophthalmic forceps, corneal scissors, and irrigation cannulas—are designed for repeated use in clinical settings, requiring rigorous sterilization and maintenance protocols. In contrast, their SofLens and PureVision2 contact lenses (e.g., daily disposable, one-day, or multifocal variants) are intended for single-use or short-term wear by patients and are classified under different regulatory pathways, primarily as Class II or Class III devices depending on their design and risk profile.

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

Information

Country
United States
Address
1400, North Goodman Street, Rochester, United States
Website
www.bausch.com
LinkedIn
—
Facebook
—
Email
[email protected]
Phone
+1-800-553-5340
PRRC Contact
Casey Costello
EUDAMED SRN
US-MF-000001029
FDA FEI Number
1920664
DUNS Number
196603781

Catalogue (7221)

Page 145 of 145
DeviceModel / ReferenceRegistriesClassStatus
Bausch + Lomb Nesofilcon A Contact Lens K113703
FDA 510(k)
Class IIActive
ABT12 multi-purpose solution K202932
FDA 510(k)
Class IIActive
Bausch + Lomb Boston SimplusMulti-Action Solution, Bausch + Lomb Boston One Step Liquid Enzymatic Cleaner K181627
FDA 510(k)
Class IIActive
Bausch + Lomb Boston Scleral Lens Case K173365
FDA 510(k)
Class IIActive
Bausch + Lomb Boston Original Cleaner, Bausch + Lomb Boston Original Conditioning Solutions K173089
FDA 510(k)
Class IIActive
EyeGility™ Inserter for Preloaded enVista IOLs K242389
FDA 510(k)
Class IActive
Boston Bl-1000-Sim08 Multi-Action Solution K024289
FDA 510(k)
Class IIActive
BOSTON XO (hexafocon A), BOSTON XO2 (hexafocon B) K171404
EUDAMEDFDA 510(k)
Class IIActive
Boston One Step Liquid Enzymatic Cleaner K200416
FDA 510(k)
Class IIActive
Biotrue ONEday with NaturMoist, Biotrue ONEday for Presbyopia with NaturMoist, Biotrue ONEday for Astigmatism with NaturMoist K151918
FDA 510(k)
Class IIActive
Renut Multiplus Mullti-Purpose Solution K020802
FDA 510(k)
Class IIActive
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 K183167
EUDAMEDFDA 510(k)
Class IIActive
NNR06 Multi-Purpose Solution K161819
FDA 510(k)
Class IIActive
Bausch + Lomb Preservative Free Lubricating and Rewetting Drops K222541
FDA 510(k)
Class IIActive
Bausch + Lomb Boston Advance Cleaner, Bausch + Lomb Boston Advance Conditioning Solution K180319
FDA 510(k)
Class IIActive
Bausch + Lomb Peroxiclear 3% Hydrogen Peroxide Cleaning & Disinfecting Solution K132216
FDA 510(k)
Class IIActive
Bausch + Lomb Bioture Oneday For Presbyopia (nesofilcon A) Contact Lens K132715
FDA 510(k)
Class IIActive
Independent Corneal Viewing Chamber (IVC-21) K211786
FDA 510(k)
UActive
Bausch + Lomb (Kalifilcon A) Soft Contact Lens, Bausch + Lomb (Kalifilcon A) Soft Contact Lens for astigmatism K200528
FDA 510(k)
Class IIActive
Bausch + Lomb Biotrue ONEday for Astigmatism(nesofilcon A) Soft (hydrophilic) Contact Lens K143632
FDA 510(k)
Class IIActive
Xact Foldable Hydrophobic Acrylic Ultraviolet Light-Absorbing Posterior Chamber Intraocular Lens (iol) P080021
FDA PMA
Class IIIActive

Related Companies

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Authorities

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FDA Recalls (2)

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

Bausch & Lomb Incorporated has two recall records, both initiated on 2003-08-25, with a status of terminated. The recalls involved mislabeling where the DP8200 Microflow Needle Packs were incorrectly labeled as DP8115 Phaco Needle Packs, and vice versa.

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

DateRecall No.ClassStatusReason
Aug 25, 2003Z-1279-03—terminated

The firm's DP8200 Microflow Needle Packs were labeled with the firm's DP8115 Phaco Needle Packs and visa versa.

Aug 25, 2003Z-1280-03—terminated

The firm's DP8200 Microflow Needle Packs were labeled with the firm's DP8115 Phaco Needle Packs and visa versa.

FDA Establishments (1)

Establishments registered with the FDA under this company group, matched by name.

  • Bausch & Lomb Incorporated Eppelheim Baden-Wurttemberg · DE FEI 3029990829