FDA.reportPublic FDA data

Bausch & Lomb Incorporated

Matched from indexed company URL: BAUSCH & LOMB

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
10325001032500Bausch & Lomb Incorporated1N2026-01-018507 PELHAM RD. GREENVILLE SC US 29615
11192791119279Bausch & Lomb Incorporated1N2026-01-0121 PARK PLACE BLVD. NORTH CLEARWATER FL US 33759
11238181000305478Bausch & Lomb Incorporated1Y2026-01-011501 Graves Mill Rd Lynchburg VA US 24502
12819501281950Bausch & Lomb Incorporated1N2026-01-01100 RESEARCH DRIVE WILMINGTON MA US 01887
13135251317628Bausch & Lomb Incorporated1Y2026-01-011400 North Goodman Street Rochester NY US 14609
13155221315522Bausch & Lomb Incorporated1N2026-01-016 Lancaster Pkwy Lancaster NY US 14086
19206641920664Bausch & Lomb Incorporated1Y2026-01-013365 TREE CT. INDUSTRIAL BLVD. Saint Louis MO US 63122
19321801000119305Bausch & Lomb Incorporated1Y2026-01-01499 SOVEREIGN CT. Manchester MO US 63011
96107313002806454Bausch & Lomb Ireland Limited T/A Bausch and Lomb Ireland1N2026-01-01UNIT 424/425, CONTACT LENS DIVISION INDUSTRIAL ESTATE, CORK RD WATERFORD Munster IE --

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
268611924904144P990027TECHNOLAS EXCIMER LASER SYSTEM (217A AND 217Z)LZS2000-02-23
268641367607607P980006PURE VISION VISIBILITY TINTED CONTACT LENS FOR EXTENDED WEARLPM1999-02-05
268841367607607P980006PURE VISION VISIBILITY TINTED CONTACT LENS FOR EXTENDED WEARLPM1999-02-05
268641495093030P960022SOFLENS66(TM)LPM1996-12-16
268651495093030P960022SOFLENS66(TM)LPM1996-12-16
268841495093030P960022SOFLENS66(TM)LPM1996-12-16
268591262809509P920055
268641262809509P920055
268642011691514P910071ADATOMED SILICONE OIL OP5000LWL1994-11-04
268641364362718P910061MODEL LI30U SOFLEX(TM) UV-ABSORB. INTRAOCULAR LENSHQL1994-09-02
268821364362718P910061MODEL LI30U SOFLEX(TM) UV-ABSORB. INTRAOCULAR LENSHQL1994-09-02
268641247276092P910056SOFLEX UV-ABSORBING SILICONE POSTERIOR CHAMBER INTRAOCULAR LENSHQL1992-01-17
268811247276092P910056SOFLEX UV-ABSORBING SILICONE POSTERIOR CHAMBER INTRAOCULAR LENSHQL1992-01-17
268821247276092P910056SOFLEX UV-ABSORBING SILICONE POSTERIOR CHAMBER INTRAOCULAR LENSHQL1992-01-17
268821200713581P890040SOF-FORM 55 (METHAFILCON A) SOFT (HYDROPHILIC LENSLPM1989-09-28
268641040976670P880090MODEL 120UV ANTERIOR CHAMBER INTRAOCULAR LENSHQL1989-12-28
268821040976670P880090MODEL 120UV ANTERIOR CHAMBER INTRAOCULAR LENSHQL1989-12-28
268641104600241P860047HYDROXYPROPYLMETHYLCELLULOSE 20MG/MLLZP1988-07-12
268591587163661P860023
268641587163661P860023
268641995452867P860022BOSTON EQUALENS (ITAFLUROFOCON A)/EQUALENS II (OPRIFOCON A) RIGID GAS PERMEABLE CONTACT LENSMWL1987-11-30
268811995452867P860022BOSTON EQUALENS (ITAFLUROFOCON A)/EQUALENS II (OPRIFOCON A) RIGID GAS PERMEABLE CONTACT LENSMWL1987-11-30
268642048469653P850068SILSOFT (ELASTOFILCON A) CONTACT LENSESLPM1985-12-31
268842048469653P850068SILSOFT (ELASTOFILCON A) CONTACT LENSESLPM1985-12-31
268641118358508P840039ULTRA VIOLET (UV) AND NON-UV ABSORBING PMMA INTRAOCULAR LENSESHQL1986-03-28
268821118358508P840039ULTRA VIOLET (UV) AND NON-UV ABSORBING PMMA INTRAOCULAR LENSESHQL1986-03-28
268591164982675P830013
268641164982675P830013
268591989362581P820070
268641989362581P820070
268591952502352P820069
268641952502352P820069
268641413988519P820065
268811413988519P820065
268591636301191P820031
268641636301191P820031
268821900565206P820005
268591534190269P810039
268641534190269P810039
268641116723696P810025AMVISC(R)LZP1983-10-18
268592072386062P800024
268642072386062P800024
268641383805644P240005enVista Envy™ hydrophobic acrylic intraocular lens (IOL), enVista Envy™ toric hydrophobic acrylic intraocular lens (IOL)MFK2024-10-10
268821383805644P240005enVista Envy™ hydrophobic acrylic intraocular lens (IOL), enVista Envy™ toric hydrophobic acrylic intraocular lens (IOL)MFK2024-10-10
268641788266817P220009StableVisc and TotalVisc Ophthalmic Viscosurgical Device (OVD)LZP2023-02-22
268821788266817P220009StableVisc and TotalVisc Ophthalmic Viscosurgical Device (OVD)LZP2023-02-22
268641758114549P210005IC-8 Apthera Intraocular Lens (IOL)POE2022-07-22
268821758114549P210005IC-8 Apthera Intraocular Lens (IOL)POE2022-07-22
268641562050266P200025ClearVisc Ophthalmic Viscosurgical Device (OVD)LZP2021-03-23
268642054594994P170035Bausch + Lomb Ultra (samfilcon A) Contact LensesLPM2018-04-30
268842054594994P170035Bausch + Lomb Ultra (samfilcon A) Contact LensesLPM2018-04-30
268641684098931P080004HOYA ISPHERIC MODEL YA-60BB INTRAOCULAR LENSHQL2008-09-26
268641777102826P060022AKREOS POSTERIOR CHAMBER INTRAOCULAR LENS,MODEL ADAPTHQL2008-09-05
268811777102826P060022AKREOS POSTERIOR CHAMBER INTRAOCULAR LENS,MODEL ADAPTHQL2008-09-05
268821777102826P060022AKREOS POSTERIOR CHAMBER INTRAOCULAR LENS,MODEL ADAPTHQL2008-09-05
268641396721261P030002CRYSTALENS MODEL AT-45 ACCOMMODATING POSTERIOR CHAMBER INTRAOCULAR LENS (IOL)NAA2003-11-14
268821396721261P030002CRYSTALENS MODEL AT-45 ACCOMMODATING POSTERIOR CHAMBER INTRAOCULAR LENS (IOL)NAA2003-11-14
268641307273208P010062EUCLID SYSTEMS ORTHOKERATOLOGY (OPRIFOCON A) CONTACT LENS FOR OVERNIGHT WEARNUU2004-06-07
268811307273208P010062EUCLID SYSTEMS ORTHOKERATOLOGY (OPRIFOCON A) CONTACT LENS FOR OVERNIGHT WEARNUU2004-06-07
268641866066809P010059MORCHER CAPSULAR TENSION RING, TYPES 14, 14A AND 14CMRJ2003-10-23
268641532772991N17676
268811532772991N17676
268821532772991N17676
268841532772991N17676
268641030173908N16895SOFLENS CONTACT LENSES (POLYMACON)LPM1971-03-18
268651030173908N16895SOFLENS CONTACT LENSES (POLYMACON)LPM1971-03-18
268841030173908N16895SOFLENS CONTACT LENSES (POLYMACON)LPM1971-03-18
268641196636909K993039VISCOUS FLUID INJECTOR SYSTEM MODULE (CX5700)MRH2000-01-07
268611348105776K984443ORBSCANMXK1999-03-05
751791087274039K983278OXYLENS TINTED, PROSTHETIC (HIOXIFILCON B) TINTED, SOFT DAILY WEAR CONTACT LENS (SIGHTED AN NON-SIGHTED EYES)LPL1998-11-25
751791722640252K983053ALDEN CLASSIC PROSTHETIC (POLYMACON) TINTED, SOFT DAILY WEAR CONTACT LENS (SIGHTED AND NON-SIGHTED EYES)LPL1998-10-21
751791695999545K981252OXYLENS (HIOXIFILCON B) SOFT (SPHERICAL & TORIC) DAILY WEAR CONTACT LENSS (CLEAR & BLUE VISIBILITY TINTED, LATHE-CUT FR)LPL1998-06-23
268612025766045K980797PEREGRINE FIBER OPTIC MULTI-FUNCTION MANIPULATORMPA1998-05-19
268642025766045K980797PEREGRINE FIBER OPTIC MULTI-FUNCTION MANIPULATORMPA1998-05-19
268641680496884K980741BOSTON EO RIGID GAS PERMEABLE CONTACT LENS MATERIAL (ENFLOFOCON B)HQD1998-05-11
268811680496884K980741BOSTON EO RIGID GAS PERMEABLE CONTACT LENS MATERIAL (ENFLOFOCON B)HQD1998-05-11
268591977965821K980591RENU MULTIPLUS LUBRICATING & REWETTING DROPSLPN1998-06-24
268641977965821K980591RENU MULTIPLUS LUBRICATING & REWETTING DROPSLPN1998-06-24
751791324230891K980554ALDEN CLASSIC TINTED (POLYMACON) SOFT (SPHERICAL & TORIC) DAILY WEAR CONTACT LENS, TINTED (TRANSPARENT/ENHANCING)LPL1998-04-07
268591215154239K980133BAUSCH & LOMB WETTING AND SOAKING SOLUTIONLPN1998-03-11
268641215154239K980133BAUSCH & LOMB WETTING AND SOAKING SOLUTIONLPN1998-03-11
268641993496992K974780SOFLENS(TM) ONE DAY DISPOSABLE (HILAFILCON A) VISIBILITY TINTED CONTACT LENSLPL1998-03-11
268591250305485K974723RENU MULTIPLUS MULTI-PURPOSE SOLUTIONLPN1998-03-10
268641250305485K974723RENU MULTIPLUS MULTI-PURPOSE SOLUTIONLPN1998-03-10
268591807463840K974466BOSTON ADVANCE CLEANERMRC1998-02-19
268641807463840K974466BOSTON ADVANCE CLEANERMRC1998-02-19
751791407210777K973967AL-47 (POLYMACON) SOFT (SPHERICAL & TORIC) DAILY WEAR CONTACT LENS (CLEAR & TINTED, LATHE-CUT FROM LENS BLANK)LPL1997-12-08
268591823065587K973217BOSTON LIQUID ENZYMATIC CLEANERLPN1997-11-24
268641823065587K973217BOSTON LIQUID ENZYMATIC CLEANERLPN1997-11-24
268641642901305K972901AMERICAN BIOSURGICAL ELECTROSURGICAL BIPOLAR CABLE/CORDGEI1997-09-19
268641301031980K972454OXYCOR (BALAFILCON A) VISIBILITY TINTED CONTACT LENSLPL1997-08-08
268611003690145K971439STORZ MICROFLOW AND STORZ STANDARD PHACOEMULSIFICATION NEEDLESHQC1997-06-17
268641003690145K971439STORZ MICROFLOW AND STORZ STANDARD PHACOEMULSIFICATION NEEDLESHQC1997-06-17
268641498394002K970727MPORT FOLDABLE LENS PLACEMENT SYSTEMMSS1997-12-17
268821498394002K970727MPORT FOLDABLE LENS PLACEMENT SYSTEMMSS1997-12-17
268641459024638K970698BOSTON ES MULTIVISION (ENFLUFOCON A) CONTACT LENSHQD1997-05-06
268811459024638K970698BOSTON ES MULTIVISION (ENFLUFOCON A) CONTACT LENSHQD1997-05-06
268611565122674K963434VISCOUS FLUID SYSTEMMRH1996-11-25
268641565122674K963434VISCOUS FLUID SYSTEMMRH1996-11-25
268611695694137K962131STORZ D4600 AIR EXCHANGE LINE PACKHQC1996-08-23
268641695694137K962131STORZ D4600 AIR EXCHANGE LINE PACKHQC1996-08-23
268611149803709K961310STORZ PREMIERE II MICROSURGICAL SYSTEM (CX SERIES)HQC1996-06-27
268641149803709K961310STORZ PREMIERE II MICROSURGICAL SYSTEM (CX SERIES)HQC1996-06-27
268821036440758K960926POWER PLUS (POLYMACON) SOFT (HYDROPHILIC) ASPHERIC CONTACT LENSLPL1996-04-10
268611664523070K960024STORZ D7120 PHACO HANDPIECE MAINTENANCE KIT & STORZ D7125 PHACO HANDPIECE NEEDLE WRENCHHQC1996-09-20
268641664523070K960024STORZ D7120 PHACO HANDPIECE MAINTENANCE KIT & STORZ D7125 PHACO HANDPIECE NEEDLE WRENCHHQC1996-09-20
268681664523070K960024STORZ D7120 PHACO HANDPIECE MAINTENANCE KIT & STORZ D7125 PHACO HANDPIECE NEEDLE WRENCHHQC1996-09-20
268841664523070K960024STORZ D7120 PHACO HANDPIECE MAINTENANCE KIT & STORZ D7125 PHACO HANDPIECE NEEDLE WRENCHHQC1996-09-20
268641605007209K960009STORZ S2050 SERIES BIPOLAR FORCEPSGEI1996-03-06
268681605007209K960009STORZ S2050 SERIES BIPOLAR FORCEPSGEI1996-03-06
268611827439812K960007STORZ MVS 1011A DISPOSABLE FIBEROPTIC ENDOILLUMINATORMPA1996-03-26
268641827439812K960007STORZ MVS 1011A DISPOSABLE FIBEROPTIC ENDOILLUMINATORMPA1996-03-26
268611012360895K960003STORZ D7116 MICROVIT VITRECTOMY CUTTER EXTENSIONHQC1996-08-29
268641012360895K960003STORZ D7116 MICROVIT VITRECTOMY CUTTER EXTENSIONHQC1996-08-29
268611730436553K954340STORZ MICROFLOW PHACOEMULSIFICATION NEEDLEHQC1995-12-14
268641730436553K954340STORZ MICROFLOW PHACOEMULSIFICATION NEEDLEHQC1995-12-14
268641423794617K953889AMERICAN BIOSURGICAL ELECTROSURGICAL BIPOLAR CABLE/CORDGEI1995-10-18
268611590175766K953575STORZ MVS-3201 VITRECTOMY PROBE PACKHQE1995-09-14
268641590175766K953575STORZ MVS-3201 VITRECTOMY PROBE PACKHQE1995-09-14

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
HQC512026-03-25
LPL442023-11-17
HQD322019-02-12
LPN242022-12-06
MSS222024-10-10
MRC132020-09-23
HQL132008-09-26
LPM112018-04-30
GEI112009-06-26
GEX92014-07-15
MVN82011-10-25
LYX62021-12-03
MPA52015-09-11
KYB52007-11-01
ONG42012-04-02
LYL42009-11-18
HQE42002-04-29
HBI41991-04-19
LZP 32021-03-23
NPL32016-08-04
QPB32011-06-23
HQF32006-06-21
MRH32000-01-07
LPM 31996-12-16
GXI31988-08-17
CAF31987-10-06
POE 22022-07-22
LRX22017-11-17
MBI22016-01-28
HQB22013-06-26
NUU22004-06-07
HNO22004-03-22
NAA 22003-11-14
HKY22001-07-02
MUW22001-02-16
MOE21995-07-26
KKX21994-04-11
HRS21991-07-26
MWL21987-11-30
NPM12017-07-18

NDC#

PURPOSE

Bausch & Lomb Incorporated

Octinoxate, Octisalate and Oxybenzone

Istalol

Bausch & Lomb Incorporated

Timolol Maleate

Xipere

Bausch & Lomb Incorporated

triamcinolone acetonide

Muro 128

Bausch & Lomb Incorporated

sodium chloride

Muro 128

Bausch & Lomb Incorporated

sodium chloride

LOTEMAX

Bausch & Lomb Incorporated

loteprednol etabonate

Alrex

Bausch & Lomb Incorporated

loteprednol etabonate

Zylet

Bausch & Lomb Incorporated

loteprednol etabonate and tobramycin

MIEBO

Bausch & Lomb Incorporated

Perfluorohexyloctane

Muro 128

Bausch & Lomb Incorporated

sodium chloride

Retisert

Bausch & Lomb Incorporated

Fluocinolone Acetonide

Opcon-A

Bausch & Lomb Incorporated

Naphazoline hydrochloride and Pheniramine maleate

Opcon-A

Bausch & Lomb Incorporated

Naphazoline hydrochloride and Pheniramine maleate

Lotemax

Bausch & Lomb Incorporated

loteprednol etabonate

Besivance

Bausch & Lomb Incorporated

Besifloxacin

Soothe XP

Bausch & Lomb Incorporated

light mineral oil and mineral oil

112 records. Showing 1-40. Next

PMA#

Akreos® Posterior Chamber Intraocular Lens (IOL)

2022-09-20

Bausch & Lomb, Inc.50 Technology Driveirvine, CA 92618 PMA NumberP060022 Supplement NumberS030 Date Received08/16/2022 Decision Date09/20/2022 Product Code HQL  Advisory Committee Ophthalmic Supplement Type30-day Notice Supplement Reason Process Change - Ma...

PMMA Anterior Chamber Intraocular Lenses

2022-08-09

Bausch & Lomb, Inc.50 Technologyirvine, CA 92618 PMA NumberP840039 Supplement NumberS064 Date Received07/11/2022 Decision Date08/09/2022 Product Code HQL  Advisory Committee Ophthalmic Supplement Type30-day Notice Supplement Reason Process Change - Manufact...

SILSOFT (ELASTOFILCON A) CONTACT LENSES

2022-03-18

Bausch & Lomb, Inc.14853 Deveau Placeminnetonka, MN 55345 PMA NumberP850068 Supplement NumberS014 Date Received02/01/2022 Decision Date03/18/2022 Product Code LPM  Advisory Committee Ophthalmic Supplement Typenormal 180 Day Track Supplement Reason Change De...

SOFLENS 38(polymacon) Soft Contact Lens

2022-03-15

Bausch & Lomb, Inc.1400 North Goodman St.rochester, NY 14609-3547 PMA NumberN16895 Supplement NumberS105 Date Received02/18/2022 Decision Date03/15/2022 Product Code LPM  Advisory Committee Ophthalmic Supplement Type30-day Notice Supplement Reason Process C...

200 records. Showing 1-40. Next

PMN#

133 records. Showing 1-40. Next

Applications#

80 records. Showing 1-40. Next

GUDID#

80 records. Showing 1-40. Next