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Bausch & Lomb, Inc.

Last updated September 17, 2026

Information

Country: US
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Catalogue (314)

Page 1 of 7

Device	Model / Reference	Registries	Class	Status
Crystalens Accommodating IOL (AT-52AO)	AT52AO-2600	FDA UDI	Class III	Unknown
I/A Handp.straight, 17g 12/Box	85782S	FDA UDI	Class II	Active
Asp Handpiece 19g 12/Box	85901S19	FDA UDI	Class II	Active
enVista® Toric IOL	MX60PT	FDA UDI	Class III	Active
Sil. Coated I/A 45 Stellaris 12/B	85910ST	FDA UDI	Class II	Active
Barraquer Lid Speculum 24b	SUH01	FDA UDI	Class I	Active
Barraquer Needle Holder, Straight	E3828 SW	FDA UDI	Class I	Active
Mics Capsulorh Fcps Curved 12/Box	SUE08-12	FDA UDI	Class I	Active
Irr.handpiece Centr.port 12/Bx	85788S	FDA UDI	Class II	Active
Zero Phaco Hdp 30deg 12/B	SUP03	FDA UDI	Class II	Active
Bausch + Lomb	X0241 A	FDA UDI	Class I	Active
Speculum Adjustable 6b	SUH04	FDA UDI	Class I	Active
23g Membrane Pick Ster.8/B	SUK01	FDA UDI	Class I	Active
Pierse Tying Forceps 12/Box	SUE05-12	FDA UDI	Class I	Active
enVista® Toric IOL	ETE	FDA UDI	Class III	Active
23G Backflush/Extrusion Handpiece blunt 6/B	SUJ11	FDA UDI	Class I	Active
Bausch + Lomb	N1822	FDA UDI	Class I	Active
Pmma (l122uv)	L122UV	FDA UDI	Class III	Active
enVista® Toric IOL	MX60PT	FDA UDI	Class III	Active
20g Ilm Forceps I/Box	SUI09EA	FDA UDI	Class I	Active
Bipol.pen Scleral Lemo 12/Bx	E7928	FDA UDI	Class II	Active
Bipol.pen 25g 2pin Taper 12/Bx	E7924	FDA UDI	Class II	Active
enVista® IOL	MX60PL	FDA UDI	Class III	Active
Akreos AOP IOL	ADAPTAOP2950	FDA UDI	Class III	Unknown
25g Asym Peeling Forceps 128	SUI05-12	FDA UDI	Class I	Active
Bausch + Lomb	E4106 H	FDA UDI	Class I	Active
I/A Handpiece Curved 17g 12/B	85783ST	FDA UDI	Class II	Active
EnVista MX60 IOL	MX60T300+145	FDA UDI	Class III	Unknown
Barraquer Needle Holder, Straight	E3828 SWO	EUDAMEDFDA UDI	Class I	Active
23g Asym Peeling Forceps 12/B	SUI03-12	FDA UDI	Class I	Active
Castroviejo Needle Holder, Curved	E3849	FDA UDI	Class I	Active
I/A Hdp.sil.tip Strght.mill 1/B	85912S EA	FDA UDI	Class II	Active
20g Backflush Hpc Brush 6/B	SUJ09	FDA UDI	Class I	Active
Sinskey Iol Hook 12/Box	SUF02	FDA UDI	Class I	Active
25g Endgripping Forceps 12/Bx	65025S-12	FDA UDI	Class I	Active
Sil I/A Handp Curved Stell 1/B	85913ST EA	FDA UDI	Class II	Active
Derf Needle Holder, Straight	E3876	EUDAMEDFDA UDI	Class I	Active
I/A Hdp.sil.tip Strght.mill 12b	85912S	FDA UDI	Class II	Active
I/A Hdp. 45 W Sleeve 1.8 12/Bx	85795ST	FDA UDI	Class II	Active
Asp Hpc Sterile Lat.port 12/Bx	85900S	FDA UDI	Class II	Active
25g Ilm Forceps 1/B	SUI08EA	FDA UDI	Class I	Active
enVista® Toric IOL	MX60PT	FDA UDI	Class III	Active
23g Serrated Forceps 128	SUI11-12	FDA UDI	Class I	Active
Mics I/A Sil.tip Strt Stel 12b	85914ST	FDA UDI	Class II	Active
Bausch + Lomb	623890	FDA UDI	Class II	Active
enVista® Toric IOL	MX60PT	FDA UDI	Class III	Active
Barraquer Needle Holder, Curved	E3828 CW	FDA UDI	Class I	Active
25g Ilm Forceps 12/Box	SUI08-12	FDA UDI	Class I	Active
enVista MX60 IOL	MX60UT425+160	FDA UDI	Class III	Unknown
enVista® Toric IOL	MX60ET	FDA UDI	Class III	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.

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.