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Sign in to claim this brandBausch & 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
- —
- —
- [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 4 of 145| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| enVista Aspire™ Toric IOL | ETA | FDA UDI | Class III | Active |
| EnVista MX60 IOL | MX60T575+115 | FDA UDI | Class III | Unknown |
| enVista MX60 IOL | MXUPT090+290 | FDA UDI | Class III | Unknown |
| Bausch + Lomb | ET8308 | FDA UDI | Class I | Active |
| Bausch + Lomb | S2050 5D | FDA UDI | Class II | Active |
| Occucoat | CC050S | FDA UDI | Class III | Active |
| enVista Aspire™ Toric IOL | ETA | FDA UDI | Class III | Active |
| Bausch + Lomb | E3796 | FDA UDI | Class I | Active |
| EnVista MX60 IOL | MX60TP500+110 | FDA UDI | Class III | Unknown |
| EnVista MX60 IOL | MX60T275+135 | FDA UDI | Class III | Unknown |
| Bausch + Lomb | N4285 | FDA UDI | Class I | Active |
| Bausch + Lomb | E9107 | FDA UDI | Class I | Active |
| Bausch + Lomb | N2994 ROT | FDA UDI | Class I | Active |
| enVista® Toric IOL | MX60ET | FDA UDI | Class III | Active |
| enVista® Toric IOL | MX60ET | FDA UDI | Class III | Active |
| enVista Aspire™ Toric IOL | ETA | FDA UDI | Class III | Active |
| Pmma (p359uv) | P359UV | FDA UDI | Class III | Active |
| enVista® Toric IOL | MX60ET | FDA UDI | Class III | Active |
| enVista® Toric IOL | MX60ET | FDA UDI | Class III | Active |
| enVista® Toric IOL | ETE | FDA UDI | Class III | Active |
| Bausch + Lomb | SE5625 | FDA UDI | Class II | Active |
| Bausch + Lomb | N5005 | FDA UDI | Class I | Active |
| Bausch + Lomb | N1705 QHR | FDA UDI | Class I | Active |
| EnVista MX60 IOL | MX60A1000 | FDA UDI | Class III | Unknown |
| enVista Envy™ Toric IOL | ETN | FDA UDI | Class III | Active |
| enVista® Toric IOL | MX60ET | FDA UDI | Class III | Active |
| ClearVisc | DVISC10 | FDA UDI | Class III | Active |
| enVista Envy™ Toric IOL | ETN | FDA UDI | Class III | Active |
| enVista® Toric IOL | ETE | FDA UDI | Class III | Active |
| Bausch + Lomb | N2941 | FDA UDI | Class I | Active |
| Bausch + Lomb | N0226 3 | FDA UDI | Class I | Active |
| enVista Aspire™ Toric IOL | ETA | FDA UDI | Class III | Active |
| enVista® Toric IOL | ETE | FDA UDI | Class III | Active |
| enVista Envy™ Toric IOL | ETN | FDA UDI | Class III | Active |
| enVista Aspire™ Toric IOL | ETA | FDA UDI | Class III | Active |
| enVista Aspire™ Toric IOL | ETA | FDA UDI | Class III | Active |
| enVista Aspire™ Toric IOL | ETA | FDA UDI | Class III | Active |
| enVista® Toric IOL | MX60PT | FDA UDI | Class III | Active |
| EnVista MX60 IOL | MX60TP275+125 | FDA UDI | Class III | Unknown |
| enVista® Toric IOL | ETE | FDA UDI | Class III | Active |
| enVista MX60 IOL | MX60UT500+190 | FDA UDI | Class III | Unknown |
| EnVista MX60 IOL | MX60TP125+110 | FDA UDI | Class III | Unknown |
| Bausch + Lomb | BL5293 | FDA UDI | Class II | Active |
| Bausch + Lomb | E2026 | FDA UDI | Class I | Active |
| Akreos® IOL | AO60 | FDA UDI | Class III | Active |
| enVista Aspire™ Toric IOL | ETA | FDA UDI | Class III | Active |
| Trulign® Toric IOL | BL1UT | FDA UDI | Class III | Active |
| Bausch + Lomb | E3199 GW US | FDA UDI | Class I | Active |
| Bausch + Lomb | ET1815 AK | FDA UDI | Class I | Active |
| enVista Aspire™ Toric IOL | ETA | FDA UDI | Class III | Active |
Related Companies
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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.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Aug 25, 2003 | Z-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, 2003 | Z-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