Is this your brand? Sign in to claim ownership.

Bausch & Lomb Incorporated

United States·US-MF-000001029

Last updated September 17, 2026

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 1 of 145

Device	Model / Reference	Registries	Class	Status
Bausch + Lomb SimplifEYE™ Inserter	21984	EUDAMED	Class IIa	Active
SofLens 38	Many	EUDAMED	Class IIa	Active
PureVision2 for Astigmatism	Many	EUDAMED	Class IIa	Active
Bausch + Lomb ULTRA ONE DAY	Many	EUDAMED	Class IIa	Active
SofLens daily disposable	Many	EUDAMED	Class IIa	Active
Bausch + Lomb ULTRA ONE DAY for Astigmatism	Many	EUDAMED	Class IIa	Active
SofLens 38	Many	EUDAMED	Class IIa	Active
PureVision2 for Presbyopia	Many	EUDAMED	Class IIa	Active
Bausch + Lomb ULTRA ONE DAY Multifocal	Many	EUDAMED	Class IIa	Active
SofLens 38	Many	EUDAMED	Class IIa	Active
SofLens 59	Many	EUDAMED	Class IIa	Active
Bausch + Lomb ULTRA for Presbyopia	Many	EUDAMED	Class IIa	Active
EnVista MX60 IOL	MX60T200+295	FDA UDI	Class III	Unknown
IC-8 Apthera IOL	+12.5 D	FDA UDI	Class III	Active
enVista MX60 IOL	MX60UT275+110	FDA UDI	Class III	Unknown
Bausch + Lomb	E2077	FDA UDI	Class I	Active
enVista Aspire™ Toric IOL	ETA	FDA UDI	Class III	Active
Bausch + Lomb	N1700 48	FDA UDI	Class I	Active
Bausch + Lomb	E2515	FDA UDI	Class I	Active
Bausch + Lomb	E0549 D	FDA UDI	Class I	Active
Bausch + Lomb	E4205	FDA UDI	Class I	Active
Bausch + Lomb	E1810	FDA UDI	Class I	Active
EnVista MX60 IOL	MX60US2650	FDA UDI	Class III	Unknown
Akreos AOP IOL	ADAPTAOP2000	FDA UDI	Class III	Unknown
Pmma (eze-60)	EZE-60	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 MX60 IOL	MX60UT125+285	FDA UDI	Class III	Unknown
Bausch + Lomb	E3050 7.50	FDA UDI	Class I	Active
enVista Aspire™ Toric IOL	ETA	FDA UDI	Class III	Active
EnVista MX60 IOL	MX60T150+215	FDA UDI	Class III	Unknown
Bausch + Lomb	E0586 S	FDA UDI	Class I	Active
Bausch + Lomb	N0613 L	FDA UDI	Class I	Active
enVista® Toric IOL	MX60PT	FDA UDI	Class III	Active
enVista® Toric IOL	MX60PT	FDA UDI	Class III	Active
Bausch + Lomb	N4318	FDA UDI	Class I	Active
IC-8 Apthera IOL	+26.5 D	FDA UDI	Class III	Active
Bausch + Lomb	IVC-12	FDA UDI	U	Active
enVista Envy™ Toric IOL	ETN	FDA UDI	Class III	Active
Bausch + Lomb	CX6805	FDA UDI	Class II	Active
enVista® Toric IOL	MX60PT	FDA UDI	Class III	Active
SoFlex® SE IOL	LI61SE	FDA UDI	Class III	Active
enVista Aspire™ Toric IOL	ETA	FDA UDI	Class III	Active
Bausch + Lomb	P1418	FDA UDI	Class I	Active
Bausch + Lomb	629605	FDA UDI	Class II	Unknown
enVista® Toric IOL	MX60PT	FDA UDI	Class III	Active
Bausch + Lomb	2-410	FDA UDI	Class I	Active
enVista® Toric IOL	MX60ET	FDA UDI	Class III	Active
EnVista MX60 IOL	MX60A1050	FDA UDI	Class III	Unknown

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

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.

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