FDA.reportPublic FDA data

JOHNSON & JOHNSON VISION CARE, INC.

Matched from indexed company URL: Johnson & Johnson Company

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
10579851000222023JOHNSON & JOHNSON VISION CARE, INC.1Y2026-01-017500 Centurion Parkway Jacksonville FL US 32256
30022949463002294946Johnson & Johnson MEDICAL GmbH1N2026-01-01ROBERT-KOCH-STRASSE 1 NORDERSTEDT Schleswig-Holstein DE 22851
30052736113005273611Johnson & Johnson International1Y2026-01-01Calle C No. 475 Suite 200; Los Frailes Industrial Park Urb Santa Paula PR US 00969
30122369363012236936Johnson & Johnson Surgical Vision, Inc.1N2026-01-0131 Technology Drive Suite 200 Irvine CA US 92618
20206643003843509Johnson & Johnson Surgical Vision, Inc.1N2020-04-251700 EAST ST. ANDREW PL. Santa Ana CA US 92705

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00381372020071BAND-AID Brand Adhesive Bandages - BANDAID Sensitive Skin Assorted 20 Count+1(866)565-2873xxx@xxx.com
00381372020088BAND-AID Brand Adhesive Bandages - BANDAID Sensitive Skin XL 7 Count+1(866)565-2873xxx@xxx.com
00381372020378BAND-AID Brand Adhesive Bandages - BANDAID Flex Fabric, Waterproof, Tough Strips 198 count Variety Club Pack+1(866)565-2873xxx@xxx.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2027721551598512P990080CEEON EDGE FOLDABLE ULTRAVIOLET LIGHT-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS, MODEL 911AHQL2001-04-05
2908261551598512P990080CEEON EDGE FOLDABLE ULTRAVIOLET LIGHT-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS, MODEL 911AHQL2001-04-05
2027721618868863P980040SENSAR SOFT ACRYLIC UV-LIGHT ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENSHQL2000-02-03
2908261618868863P980040SENSAR SOFT ACRYLIC UV-LIGHT ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENSHQL2000-02-03
2027721020177659P960028AMO ARRAY MULTIFOCAL UV-ABSORBING SILCONE POSTERIOR CHAMBER INTRAOCULAR LENSMFK1997-09-05
2908261020177659P960028AMO ARRAY MULTIFOCAL UV-ABSORBING SILCONE POSTERIOR CHAMBER INTRAOCULAR LENSMFK1997-09-05
2027721622246011P930016VISX EXCIMER LASER SYSTEM MODELS B AND CLZS1996-03-27
2908261622246011P930016VISX EXCIMER LASER SYSTEM MODELS B AND CLZS1996-03-27
2027721795776864P880081UV ABSORBING SILICONE POSTERIOR CHAMBER INTRAOCULAR LENSESHQL1989-10-31
2908261795776864P880081UV ABSORBING SILICONE POSTERIOR CHAMBER INTRAOCULAR LENSESHQL1989-10-31
2027721641652382P860061
2908261641652382P860061
2027721236018257P850088
2908261236018257P850088
2027721053755015P810031HEALON, HEALON GV, HEALON5 PRODUCTS SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVICESLZP1983-01-14
2908261053755015P810031HEALON, HEALON GV, HEALON5 PRODUCTS SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVICESLZP1983-01-14
2027721949115006P110007HEALON ENDOCOAT OPVISCOSURGICAL OPHTHALMIC DEVICE (OVD) (3% SODIUM HYALURONATE)LZP2012-07-02
2908261949115006P110007HEALON ENDOCOAT OPVISCOSURGICAL OPHTHALMIC DEVICE (OVD) (3% SODIUM HYALURONATE)LZP2012-07-02
2027721226142356P080010TECNIS MULTIFOCAL FOLDABLE POSTERIOR CHAMBER INTRAOCULAR LENS (IOL)MFK2009-01-16
2908261226142356P080010TECNIS MULTIFOCAL FOLDABLE POSTERIOR CHAMBER INTRAOCULAR LENS (IOL)MFK2009-01-16
281751367075940P040045VISTAKON (SENOFILCON A) CONTACT LENS, CLEAR AND VISIBILITY TINTED WITH UV BLOCKERLPM2005-12-20
281751311595570N18033ACUVUE CONTACT LENSLPM1980-03-18
2027721349276052N18020
2908261349276052N18020
281751922456284K994324ACUVUE (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS CLEAR AND VISIBILITY TINTED WITH UV BLOCKERLPL2000-02-23
2027721516541048K984383ULTRACARE NEUTRALIZING TABLETSLPN1998-12-18
2908261516541048K984383ULTRACARE NEUTRALIZING TABLETSLPN1998-12-18
2027721608188626K981116SOVEREIGN CATARACT EXTRACTION SYSTEMKYG1998-05-19
2908261608188626K981116SOVEREIGN CATARACT EXTRACTION SYSTEMKYG1998-05-19
2027721647283280K961242AMO PHACOFLEX II INTERSECTION SYSTEMKYB1996-06-17
2908261647283280K961242AMO PHACOFLEX II INTERSECTION SYSTEMKYB1996-06-17
2027721225079559K955455BAERVELT PARS PLANA GLAUCOMA IMPLANTKYF1997-02-18
2908261225079559K955455BAERVELT PARS PLANA GLAUCOMA IMPLANTKYF1997-02-18
2027721585440469K951462AMO PROFINESSE III ULTRASONIC HANDPIECE SYSTEMHQC1995-06-15
2908261585440469K951462AMO PROFINESSE III ULTRASONIC HANDPIECE SYSTEMHQC1995-06-15
2027721685992194K943672PHACO NEEDLES AND TIPSHQC1994-10-13
2908261685992194K943672PHACO NEEDLES AND TIPSHQC1994-10-13
2027721596482085K905129BAERVELDT GLAUCOMA IMPLANTKYF1991-02-11
2908261596482085K905129BAERVELDT GLAUCOMA IMPLANTKYF1991-02-11
2027721719058269K904909I/A VITROPHAGE MODEL YPR 2001HQE1991-01-28
2027721399518901K844373O.M.S. ULTRA-PHACOHQC1985-12-19
2908261399518901K844373O.M.S. ULTRA-PHACOHQC1985-12-19
2027721162991708K840695PHACOEMULSIFICATION KITSHQC1984-05-22
2908261162991708K840695PHACOEMULSIFICATION KITSHQC1984-05-22
2027721606274572K831236BIPOLAR CARDGEI1983-06-02
2908261606274572K831236BIPOLAR CARDGEI1983-06-02
2027721035957190K760684VISC X-VITREOUS ASPIRATING & CUT. INSTRHKP1976-10-05
2908261035957190K760684VISC X-VITREOUS ASPIRATING & CUT. INSTRHKP1976-10-05
281751551989805K210930ACUVUE® OASYS MAX 1-DAY Contact Lenses (senofilcon A)LPL2021-11-29
2908261000670424K203060VERITAS Phacoemulsification Console, VERITAS Advanced Fluidics Pack and Advanced Infusion Pack, VERITAS Swivel Handpiece, VERITAS Advanced Foot Pedal, VERITAS Remote ControlHQC2021-03-12
281751796691733K200243ACUVUE (senofilcon A) Soft Contact Lens MultifocalLPL2020-03-17
2027722010502988K191949UNFOLDER Vitan InserterMSS2019-09-13
2908262010502988K191949UNFOLDER Vitan InserterMSS2019-09-13
851932024215446K183183VICRYL Polyglactin 910 Sterile Synthetic Absorbable Surgical Suture, PDS II Polydioxanone Sterile Synthetic Absorbable Surgical Suture, PDS Plus Antibacterial Polydioxanone Sterile Synthetic Absorbable Surgical SutureGAM2019-06-27
851931475918027K180910ULTRAPRO Mesh and ULTRAPRO ADVANCEDFTL2018-07-02
281751366468678K180299ACUVUE OASYS (senofilcon A) with Photochromic AdditiveLPL2018-04-10
2027721172874220K160236Dual Pump PackHQC2016-04-27
2908261172874220K160236Dual Pump PackHQC2016-04-27
281751412987082K160212ACUVUE (senofilcon C) Soft Contact LensLPL2016-03-28
2027721649229507K151783COMPACT INTUITIV Multiple-Use PackHQC2015-09-02
2908261649229507K151783COMPACT INTUITIV Multiple-Use PackHQC2015-09-02
2027721291926804K151636AMO WHITESTAR Signature Pro Phacoemulsification System, WHITESTAR Signature Pro Advance Linear (Four-Button) Foot Pedal, WHITESTAR Signature Pro (Wireless) Remote ControlHQC2015-10-19
2908261291926804K151636AMO WHITESTAR Signature Pro Phacoemulsification System, WHITESTAR Signature Pro Advance Linear (Four-Button) Foot Pedal, WHITESTAR Signature Pro (Wireless) Remote ControlHQC2015-10-19
2027722030216947K143434One Series ULTRA Cartridge, The UNFOLDER Platinum 1 SeriesMSS2015-05-06
2908262030216947K143434One Series ULTRA Cartridge, The UNFOLDER Platinum 1 SeriesMSS2015-05-06
281751674274116K141670ACUVUE (ETAFILCON A) SOFT CONTACT LENS FOR PRESBYOPIALPL2014-09-18
851931818605693K141560ETHICON PHYSIOMESH OPEN FLEXIBLE COMPOSITE MESH DEVICEFTL2014-10-23
2027721835231038K141079OPTIMEDICA CATALYS PRECISION LASER SYSTEMOOE2014-09-11
2908261835231038K141079OPTIMEDICA CATALYS PRECISION LASER SYSTEMOOE2014-09-11
851931455404624K133198ULTRAPRO COMFORT PLUGFTL2014-05-30
2027721213958742K133115COMPACT INTUITIV; SYSTEM, WIRELESS REMOTE CONTROL, FOUR-BUTTON FOOT PEDAL, SINGLE-USE FLUIDICS PACKHQC2014-02-27
2908261213958742K133115COMPACT INTUITIV; SYSTEM, WIRELESS REMOTE CONTROL, FOUR-BUTTON FOOT PEDAL, SINGLE-USE FLUIDICS PACKHQC2014-02-27
2027721606299737K121721LAMINAR FLOW PHACO TIPS AND IRRIGATION SLEEVE (21G, REUSABLE)HQC2012-10-15
2908261606299737K121721LAMINAR FLOW PHACO TIPS AND IRRIGATION SLEEVE (21G, REUSABLE)HQC2012-10-15
2027721126082280K121091CATALYS PRECISION LASER SYSTEMOOE2012-08-28
2908261126082280K121091CATALYS PRECISION LASER SYSTEMOOE2012-08-28
2027721490834348K113479OPTIMEDICA CATALYS PRECISION LASER SYSTEMOOE2011-12-21
2908261490834348K113479OPTIMEDICA CATALYS PRECISION LASER SYSTEMOOE2011-12-21
851931860854290K113205ARTISYN Y-SHAPED MESHOTO2012-06-11
2027721382269667K111882LAMINAR FLOW PHACO TIPSHQC2011-11-07
2908261382269667K111882LAMINAR FLOW PHACO TIPSHQC2011-11-07
2027721812911567K111697AMO WHITESTAR SIGNATURE PHACOEMULSIFICATION SYSTEMHQC2011-09-27
2908261812911567K111697AMO WHITESTAR SIGNATURE PHACOEMULSIFICATION SYSTEMHQC2011-09-27
2027721011033539K111446SOVEREIGN COMPACT PHACOEMULSIFICATION SYSTEMHQC2011-12-21
2908261011033539K111446SOVEREIGN COMPACT PHACOEMULSIFICATION SYSTEMHQC2011-12-21
281751609003874K100349VISTAKON (NARAFILCON B) CONTACT LENS VISIBILITY TINTED WITH UV BLOCKERLPL2010-05-21
2027721431571914K093254AMO BRAND MULTI-PURPOSE DISINFECTING SOLUTIONLPN2010-09-15
2908261431571914K093254AMO BRAND MULTI-PURPOSE DISINFECTING SOLUTIONLPN2010-09-15
851931548977163K092590PDS PLATESNHB2010-02-17
2027722015677032K081681VITRECTOMY CUTTER AND ACCESSORIESMLZ2008-10-08
2908262015677032K081681VITRECTOMY CUTTER AND ACCESSORIESMLZ2008-10-08
2027721914767872K081545ONE SERIES ULTRA CARTRIDGE, MODEL 1VIPR30MSS2008-10-02
2908261914767872K081545ONE SERIES ULTRA CARTRIDGE, MODEL 1VIPR30MSS2008-10-02
281751477116573K073485VISTAKON (NARAFILCON) A SOFT CONTACT LENSLPL2008-03-03
2027721376809004K073404IFS LASER SYSTEMGEX2008-04-25
2908261376809004K073404IFS LASER SYSTEMGEX2008-04-25
851931818133247K071249ULTRAPRO* HERNIA SYSTEM, MODELS UHSL, UHSM, UHSOVFTL2007-06-05
851931005028630K070224ULTRAPRO PLUGFTL2007-04-17
281751556493702K062614VISTAKON (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS, CLEAR AND TINTED (VISIBILITY AND/OR COSMETICALLY)LPL2006-11-01
851931454780297K061533PROCEED VENTRAL PATCHFTL2006-12-11
851931838460949K060713PROCEED SURGICAL MESHFTL2006-05-25
2027721802087151K060372INTRALASE FS LASER, INTRALASE FS30 LASER, MODELS 1, 2, 3GEX2006-08-16
2908261802087151K060372INTRALASE FS LASER, INTRALASE FS30 LASER, MODELS 1, 2, 3GEX2006-08-16
2027721391407475K060366THE AMO OPHTHALMIC SURGICAL SYSTEMHQC2006-04-07
2908261391407475K060366THE AMO OPHTHALMIC SURGICAL SYSTEMHQC2006-04-07
281751901877631K051900ACUVUE (ETAFILCON A) CONTACT LENS, CLEAR AND WITH VISIBILITY TINT WITH UV BLOCKER, FOR DAILY WEARMVN2005-08-12
851931526217743K051701VICRYL * MESH BAGFTL2005-09-29
281751239955331K042275VISTAKON (SENOFILCON A) SOFT CONTACT LENSLPL2004-10-28
2027721215689155K040839COMPLETE BLINK-N-CLEAN LENS DROPSMRC2004-10-19
281751925659835K033969ACUVUE 2 COLOURS BRAND (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS WITH UV BLOCKERLPL2004-02-04
281751068461747K032340VISTAKON (GALYFILCON A) SOFT CONTACT LENSLPL2003-10-16
2027721626507872K032030BLINK CL LUBRICANT EYE DROPSLPN2003-09-25
2027721320870476K014202COMPLETE BRAND MULTI-PURPOSE SOLUTIONLPN2002-02-20
2908261320870476K014202COMPLETE BRAND MULTI-PURPOSE SOLUTIONLPN2002-02-20
281751533812276K013973ACUVUE BRAND (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES; CLEAR AND TINTED (VISIBILITY AND/OR COSMETIC) WITH UV BLOCLPL2002-02-26
2027721424714328K012105POLYVAC SURGICAL INSTRUMENT DELIVERY SYSTEMKCT2002-08-02
2908261424714328K012105POLYVAC SURGICAL INSTRUMENT DELIVERY SYSTEMKCT2002-08-02
2027721806672738K003638MOJAVE CATARACT EXTRACTION SYSTEMHQC2001-02-13
2908261806672738K003638MOJAVE CATARACT EXTRACTION SYSTEMHQC2001-02-13
2027721097035559

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
HQC292021-03-12
LPL132021-11-29
FTL82018-07-02
LPN72010-09-15
MSS62019-09-13
OOE62014-09-11
HQL62001-04-05
GEX42008-04-25
KYF41997-02-18
LZP 22012-07-02
MFK22009-01-16
MLZ22008-10-08
LPM22005-12-20
KCT22002-08-02
KYG21998-05-19
MFK 21997-09-05
KYB21996-06-17
LZS21996-03-27
GEI21983-06-02
LZP21983-01-14
HKP21976-10-05
GAM12019-06-27
OTO12012-06-11
NHB12010-02-17
MVN12005-08-12
MRC12004-10-19
HQE11991-01-28

PMA#

TECNIS® Multifocal Foldable Posterior Chamber IOL

2022-12-06

Johnson & Johnson Surgical Vision, Inc.31 Technology Drivesuite 200irvine, CA 92618 PMA NumberP080010 Supplement NumberS021 Date Received11/09/2022 Decision Date12/06/2022 Product Code MFK  Advisory Committee Ophthalmic Supplement Type30-day Notice Suppleme...

TECNIS® Foldable Acrylic IOL

2022-12-06

Johnson & Johnson Surgical Vision, Inc.31 Technology Drivesuite 200irvine, CA 92618 PMA NumberP990080 Supplement NumberS056 Date Received11/09/2022 Decision Date12/06/2022 Product Code HQL  Advisory Committee Ophthalmic Supplement Type30-day Notice Suppleme...

TECNIS® CL Foldable Silicone Posterior Chamber IOL

2022-12-06

Johnson & Johnson Surgical Vision, Inc.31 Technology Drivesuite 200irvine, CA 92618 PMA NumberP880081 Supplement NumberS047 Date Received11/09/2022 Decision Date12/06/2022 Product Code HQL  Advisory Committee Ophthalmic Supplement Type30-day Notice Suppleme...

JJSV’s intraocular lenses (IOLs)

2022-05-18

Johnson & Johnson Surgical Vision, Inc.1700 E. St. Andrew Placesanta Ana, CA 92705 PMA NumberP980040 Supplement NumberS147 Date Received04/28/2022 Decision Date05/18/2022 Product Code HQL  Advisory Committee Ophthalmic Supplement Type30-day Notice Supplemen...

TECNIS IOLs

2022-03-30

Johnson & Johnson Surgical Vision, Inc.1700 E. St. Andrew Placesanta Ana, CA 92705 PMA NumberP980040 Supplement NumberS146 Date Received03/02/2022 Decision Date03/30/2022 Product Code HQL  Advisory Committee Ophthalmic Supplement Type30-day Notice Supplemen...

200 records. Showing 1-40. Next

PMN#

200 records. Showing 1-40. Next

GUDID#

80 records. Showing 1-40. Next