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Sign in to claim this brandWhat 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.
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Catalogue (314)
Page 4 of 7| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Irr Handpiece Sterile 12/Box | 85781S | FDA UDI | Class II | Active |
| Chopper Irr End-Out 19g 12/B | 85903ST19 | FDA UDI | Class II | Active |
| Capsulorhexis Forceps 12/Box | SUE01-12 | FDA UDI | Class I | Active |
| EnVista MX60 IOL | MX60T425+120 | FDA UDI | Class III | Unknown |
| 23g Ilm Forceps 12/Box | SUI07-12 | FDA UDI | Class I | Active |
| Castroviejo Needle Holder, Curved | E3861 WHMC | EUDAMEDFDA UDI | Class I | Active |
| EnVista MX60 IOL | MX60TP350+150 | FDA UDI | Class III | Unknown |
| Asp Handpiece 20g 12/Box | 85901S20 | FDA UDI | Class II | Active |
| enVista Envy™ Toric IOL | ETN | FDA UDI | Class III | Active |
| Silicone I/A Handp Curved 1/B | 85913S EA | FDA UDI | Class II | Active |
| Mics Silicone I/A Hdpc 45° 1/B | 85915S EA | FDA UDI | Class II | Active |
| Mics Sil I/A Hdp 45° Stell 12b | 85915ST | FDA UDI | Class II | Active |
| 20g Backflush Hpc Tube 6/B | SUJ10 | FDA UDI | Class I | Active |
| McPherson Needle Holder, Curved | E3835 | EUDAMEDFDA UDI | Class I | Active |
| I/A Handp.curved, 17g 12/Box | 85783S | FDA UDI | Class II | Active |
| Nucleus Y-Hook Horizontal 12b | SUF05 | FDA UDI | Class I | Active |
| Mics Silicone I/A Hdpc 45° 12/B | 85915S | FDA UDI | Class II | Active |
| Akreos® IOL | AO60 | FDA UDI | Class III | Active |
| B & L Ophthalmic Chair | K791105 | FDA 510(k) | Class I | Active |
| Crystalsert Delivery System | K132593 | FDA 510(k) | Class I | Active |
| Zyoptix Xp Epi Separator System | K062465 | FDA 510(k) | Class I | Active |
| Soflens Daily Disposable Toric (hilafilcon B) Visibility Tinted Contact Lens | K080755 | FDA 510(k) | Class II | Active |
| Sight Saver All Purpose Lens Carrying Case | K852384 | FDA 510(k) | U | Active |
| Hansatome Microkeratome | K010260 | FDA 510(k) | Class I | Active |
| Bausch & Lomb Frequent Replacement Case System | K896685 | FDA 510(k) | Class II | Active |
| Bausch & Lomb Osl-2000 Slit Lamp | K862516 | FDA 510(k) | Class II | Active |
| Soundchoice Bte | K921122 | FDA 510(k) | Class I | Active |
| Crystalsert Crystalens Delivery System | K082944 | FDA 510(k) | Class I | Active |
| Easy-Load Lens Delivery System | K161012 | FDA 510(k) | Class I | Active |
| Ray-Ban Sun Glasses | K791499 | FDA 510(k) | Class I | Active |
| Programmable Auditory Comparator, Modification | K911726 | FDA 510(k) | Class II | Active |
| Bausch & Lomb D4600a Air Exchange Line Pack | K082132 | FDA 510(k) | Class II | Active |
| Renu Multiplus Multi-Purpose Solution | K001539 | FDA 510(k) | Class II | Active |
| Bausch & Lomb Vertometer V-5 | K862518 | FDA 510(k) | Class I | Active |
| Bausch & Lomb Psl-3000 Slit Lamp | K862520 | FDA 510(k) | Class II | Active |
| Documenting Laser Slit Lamp, Dp 2010 | K012873 | FDA 510(k) | Class II | Active |
| Bausch & Lomb Contact Lens Viewer | K862517 | FDA 510(k) | Class I | Active |
| Bausch & Lomb Iol Injector | K113852 | FDA 510(k) | Class I | Active |
| Renu Multiplus Multi-Purpose Solution | K990422 | FDA 510(k) | Class II | Active |
| Pre-Moistened Cleansing Pad | K890514 | FDA 510(k) | U | Active |
| Interplak Home Plaque Removal Instrument | K910610 | FDA 510(k) | Class I | Active |
| Crystalsert Lens Delivery System | K173480 | FDA 510(k) | Class I | Active |
| Bausch & Lomb Cleaning Pad | K843511 | FDA 510(k) | Class II | Active |
| Renu Multiplus No Rub Multi-Purpose Solution | K011796 | FDA 510(k) | Class II | Active |
| Stellaris Elite Vision Enhancement System | K162342 | FDA 510(k) | Class II | Active |
| Hansatome Excellus Microkeratome | K021640 | FDA 510(k) | Class I | Active |
| Zyoptix Xp Microkeratome | K040204 | FDA 510(k) | Class I | Active |
| Fluorescence Illuminator Accessory | K770652 | FDA 510(k) | Class I | Active |
| Flatpack Carrying Case | K841316 | FDA 510(k) | N/A | Active |
| Concentrated Cleaner For Hard Contacts | K820818 | FDA 510(k) | U | 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. |