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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: —
LinkedIn: —
Facebook: —
Email: —
Phone: —
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: —
DUNS Number: —

Catalogue (314)

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Device	Model / Reference	Registries	Class	Status
Irr Handpiece Smooth 12/Box	85787S	FDA UDI	Class II	Active
enVista MX60 IOL	MX60UT200+235	FDA UDI	Class III	Unknown
20g Backflush Hpc Blunt 6/B	SUJ08	FDA UDI	Class I	Active
Mcpherson Tying Forceps 12/Box	SUE04-12	FDA UDI	Class I	Active
Mics I/A Sil.tip Strt Stel 1/B	85914ST EA	FDA UDI	Class II	Active
25g Membrane Pick Ster.8/B	SUK02	FDA UDI	Class I	Active
Bipol.pen 25g Lemo Taper 12bx	E7926	FDA UDI	Class II	Active
I/A Hdp.sil.tip Strt.stel 12/B	85912ST	FDA UDI	Class II	Active
enVista® Toric IOL	MX60PT	FDA UDI	Class III	Active
Mics Sil I/A Hdp 45° Stell 1/B	85915ST EA	FDA UDI	Class II	Active
enVista MX60 IOL	MX60UT200+150	FDA UDI	Class III	Unknown
20g Serrated Forceps 128	SUI10-12	FDA UDI	Class I	Active
25G Backflush/Extrusion Handpiece blunt 6/B	SUJ14	FDA UDI	Class I	Active
Koch Stop Chop Manipul 12b	SUF01	FDA UDI	Class I	Active
Irr Handpiece Smooth, 20g, 12/Bx	85902S20	FDA UDI	Class II	Active
Bipol.pen 23g 2pin Taper 12/Bx	E7931	FDA UDI	Class II	Active
enVista® Toric IOL	MX60PT	FDA UDI	Class III	Active
Irr. Handpiece Smooth 12/Bx	85787ST	FDA UDI	Class II	Active
Pmma (eze-60)	EZE-60	FDA UDI	Class III	Active
Sil. Coated I/A 45 Mil 12/B	85910S	FDA UDI	Class II	Active
25g Serrated Forceps 12/B	SUI12-12	FDA UDI	Class I	Active
Zero Phaco Hp 2.2 30d Stel.12b	SUP04ST	FDA UDI	Class II	Active
I/A Hndpc.cvd.w/Sleeve 1.8 12/B	85794ST	FDA UDI	Class II	Active
enVista Aspire™ Toric IOL	ETA	FDA UDI	Class III	Active
I/A Hdp.sil.tip Strt.stel 1/B	85912ST EA	FDA UDI	Class II	Active
23g Asp Handpiece Rough 12/Box	85792S	FDA UDI	Class II	Active
Tying Forceps Straight 12/Box	SUE03-12	FDA UDI	Class I	Active
Troutman Needle Holder, Curved	E3839 X	EUDAMEDFDA UDI	Class I	Active
Drysdale Nucleus Manipulator 12b	SUF04	FDA UDI	Class I	Active
20g Ilm Forceps 12box	SUI09-12	FDA UDI	Class I	Active
22g Irr Handpiece Smooth 12b	85806S	FDA UDI	Class II	Active
23g Ilm Forceps I/Box	SUI07EA	FDA UDI	Class I	Active
23g Irr Hp Smooth Stell 12b	85807ST	FDA UDI	Class II	Active
I/A Handp.straig.w.sleeve 12bx	85785S	FDA UDI	Class II	Active
22g Irr Hp Smooth Stell 12b	85806ST	FDA UDI	Class II	Active
Bipol.pen 23g Tpd Lemo 12/Bx	E7930	FDA UDI	Class II	Active
Sil. Coated I/A 45 Stellaris 1/B	85910ST EA	FDA UDI	Class II	Active
Mics I/A Sil.tip Strt Mill 12b	85914S	FDA UDI	Class II	Active
I/A Handp.tip 45deg.17g.12box	85784S	FDA UDI	Class II	Active
Barraquer Needle Holder, Curved	E3843	FDA UDI	Class I	Active
Sil I/A Handp Curved Stell 12/B	85913ST	FDA UDI	Class II	Active
Phaco Spatula 12/Box	SUF03	FDA UDI	Class I	Active
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™+	K261264	FDA 510(k)	Class II	Active
23g Passive Asp Hp W/Soft Tip 12b	SUJ01	FDA UDI	Class I	Active
Silicone I/A Handp Curved 12/B	85913S	FDA UDI	Class II	Active
EnVista MX60 IOL	MX60P2600	FDA UDI	Class III	Unknown
Bausch + Lomb	E1882	FDA UDI	Class I	Active
Barraquer Needle Holder, Curved	E3842	EUDAMEDFDA UDI	Class I	Active
Sil. Coated I/A 45 Mil 1/B	85910S EA	FDA UDI	Class II	Active
Castroviejo Needle Holder, Straight	E3862	EUDAMEDFDA UDI	Class I	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.