FDA Browser
by
Innolitics
Anesthesiology
Review Panel
Cardiovascular
Review Panel
Chemistry
Review Panel
Dental
Review Panel
Ear, Nose, Throat
Review Panel
Gastroenterology and Urology
Review Panel
General Hospital
Review Panel
Hematology
Review Panel
Immunology
Review Panel
Microbiology
Review Panel
Neurology
Review Panel
Obstetrical and Gynecological
Review Panel
Ophthalmic
Review Panel
Miscellaneous
Miscellaneous
OGO
Intraocular Pressure Lowering Implant
3
Product Code
QQU
Digital Therapy Device For Amblyopia
2
Product Code
HPX
Lens, Contact (Polymethylmethacrylate)
U
Product Code
LOG
Catheter, Balloon For Retinal Reattachment
3
Product Code
LOH
System, Identification, Contact Lens
3
Product Code
LOI
Laser, Neodymium:Yag, Ophthalmic For Uses Other Than Posterior Capsulotomy & Cutting Pupillary
3
Product Code
LQB
Medical Computers And Software For Ophthalmic Use
3
Product Code
LQE
Implant, Corneal, Refractive
3
Product Code
LXQ
Cup, Eye
U
Product Code
LYX
Media, Corneal Storage
U
Product Code
LZQ
Tissue Adhesive For Ophthalmic Use
3
Product Code
LZR
Ultrasound, Cyclodestructive
3
Product Code
LZS
Excimer Laser System
3
Product Code
LZU
Plug, Punctum
U
Product Code
MRJ
Ring, Endocapsular
3
Product Code
MSI
Solution, Cleaning / Lubricating, Artificial Eye
3
Product Code
MTA
Lens, Intraocular, Phakic
3
Product Code
MUR
Graft, Sclera, Reinforcement
3
Product Code
MWD
Electrosurgical, Radio Frequency, Refractive Correction
3
Product Code
NBF
Prosthesis, Retinal
F
Product Code
NCJ
Telescope, Implantable, Miniature
3
Product Code
ODK
Refractive Corneal Implant
F
Product Code
OKS
Lacrimal Stents And Intubation Sets
U
Product Code
OTL
Femtosecond Laser System For Refractive Correction
3
Product Code
OXW
Stimulator, Electrical, Transcutaneous, For Diabetic Retinopathy
N
Product Code
PFZ
Ophthalmic Sealant
3
Product Code
QBT
Artificial Iris
3
Product Code
QIT
Daily Wear Soft Contact Lens To Reduce The Progression Of Myopia
3
Product Code
QCW
Corneal Storage Media With Preservatives Including Anti-Fungal
2
Product Code
SAX
Home Monitoring Ophthalmic Optical Coherence Tomography (Oct) Imaging Device
2
Product Code
QQJ
Applicator, Negative Pressure, External, Ocular
2
Product Code
SDE
Light Based Device For Dry Age-Related Macular Degeneration
2
Product Code
QUR
Prescription Spectacle Lenses To Reduce The Progression Of Myopia
2
Product Code
Submissions with No Product Code
Miscellaneous
K
87
1326
DROP MATE
Cleared 510(K)
K
87
0905
SURE DROP
Cleared 510(K)
K
86
3662
OPHTHALMIC SURGICAL DRAPE
Cleared 510(K)
K
86
3666
THE SAVER KIT
Cleared 510(K)
K
86
1415
CANON AUTO REF KERATOMETER RK-1
Cleared 510(K)
K
86
1163
XTAL X-800 SHADOWGRAPH
Cleared 510(K)
K
86
1333
ULTRA-VIOLET GOGGLETS
Cleared 510(K)
K
86
1028
SUPERLITE PENLIGHT
Cleared 510(K)
K
86
0928
EYEMETER
Cleared 510(K)
K
85
4872
VFI/VFE SYSTEM II
Cleared 510(K)
P
08
0010
TECNIS 3-Poece Multifocal
OK30
PMA Approval
P
08
0010
Tecnis 3-piece Multifocal
OK30
PMA Approval
P
81
0031
Sodium Hyaluronate Ophtalmic Viscoelastc Devices (OVD); Healon PRO, Healon5 PRO, and Healon DUet PRO Dual Pack
APPR
PMA Approval
P
81
0031
HEALON SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVICES (OVD), HEALON5 SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVI
APPR
PMA Approval
P
06
0011
RAYNER C-FLEX 570C, C-FLEX ASPHERIC 970C AND 600C ASPHERIC INTRAOCULAR LENSES
APPR
PMA Approval
P
06
0011
RAYNER C-FLEX 570C, C-FLEX ASPHERIC 970C AND 600C ASPHERIC INTRAOCULAR LENSES
OK30
PMA Approval
P
98
0040
SENSAR SOFT ACRYLIC INTRAOCULAR LENSES
OK30
PMA Approval
P
98
0040
TECNIS 1- PIECE IOL WITH TECNIS ITEC, TECNIS MULTIFOCAL 1-PIECE IOL WITH THE TECNIS ITEC, AND TECNIS TORIC 1-PIECE IOL
OK30
PMA Approval
P
06
0011
RAYNER C-FLEX 570C AND C-FLEX ASPHERIC 970C INTRAOCULAR LENSES
OK30
PMA Approval
P
98
0040
TECNIS 1-PIECE IOL, MODEL:ZCB00,TECNIS MULTIFOCAL 1-PIECE IOL, MODEL:ZMB00,TECNIS TORIC 1-PIECE IOL,MODELS:ZCT150, ZCT22
OK30
PMA Approval
P
98
0040
TECNIS 1 PIECE IOL WITH THE TECNIS ITEC PRELOADED DELIVERY SYSTEM); TECNIS MULTIFOCAL 1 PIECE IOL WITH THE TECNIS ITEC P
OK30
PMA Approval
P
98
0040
TECNIS 1-PIECE LENS MODEL ZCB00; TECNIS MULTIFOCAL 1-PIECE LENS MODEL ZBM00, SENSAR 1-PIECE LENS MODEL AAB00; TECNIS 1-P
OK30
PMA Approval
P
98
0040
SENSAR 1-PIECE LENS MODEL AAB00
OK30
PMA Approval
P
98
0040
TECNIS 1-PIECE IOL WITH TECNIS ITEC PRELOADED DELIVERY SYSTEM, TECNIS MULTIFOCAL 1-PIECE IOL WITH THE TECNIS ITEC PRELOA
OK30
PMA Approval
P
98
0040
TECNIS 1-PIECE LENS MODEL ZCB00; TECNIS MULTIFOCAL 1-PIECE LENS MODEL ZMB00; SENSAR 1-PIECE LENS MODEL AAB00; TECNIS 1-P
OK30
PMA Approval
P
98
0040
TECNIS OPTIBLUE 1-PIECE IOL
APPR
PMA Approval
P
98
0040
TECNIS 1-PIECE IOL TEDNIS OPTIBLUE 1-PIECE IOL, TECNIS MULTIFOCAL 1-PIECE IOL
OK30
PMA Approval
P
98
0040
SENSAR ACRYLIC IOL, TECNIS 1-PIECE IOL, TECNIS OPTIBLUE 1-PIECE IOL, TECNIS MULTIFOCAL 1-PIECE IOL
OK30
PMA Approval
P
99
0080
SILICONE POSTERIOD CHAMBER INTRAOCULAR LENS, MODEL Z9000 INTRAOCULAR LENS MD 911A
APPR
PMA Approval
K
85
4764
LECTROSTILL DISTILLED WATER U.S.P.
Cleared 510(K)
K
85
4140
MODIFIED MYDRIATIC SPECTACLE
Cleared 510(K)
K
85
4169
PUPILSCAN
Cleared 510(K)
K
85
4256
KEELER AMOILS SURGICAL ASTIGOMETER
Cleared 510(K)
K
85
3631
POLY-SLEEVE
Cleared 510(K)
K
85
3061
MST MODEL #ARLG-5
Cleared 510(K)
K
85
3199
INTEGRITY EYE DROP GUIDE(MODIFICATION)
Cleared 510(K)
K
84
2814
PERMALID LINER PAK
Cleared 510(K)
K
84
2781
PERMALID PAK
Cleared 510(K)
K
85
2187
SITE INFUSION CONTACT LENS W/ILLUMINATOR
Cleared 510(K)
K
85
2229
STERILE EYE PACKS OR TRAYS
Cleared 510(K)
K
85
1908
INTEGRITY EYE DROP GUIDE
Cleared 510(K)
K
85
0649
ABSORBABLE INTRACANALICULAR COLLAGEN IMPLANT
Cleared 510(K)
K
85
1008
ELECTRIC LIFT TABLE-OPHTHALMIC
Cleared 510(K)
K
85
0962
OPHTHALMIC DROPPER BOTTLES
Cleared 510(K)
K
84
1430
LASERSPEC
Cleared 510(K)
K
84
1896
EZ EYE DROP AID
Cleared 510(K)
K
84
3345
AGL400 ARGON LASER SYSTEM-KRL500 KRYPTON
Cleared 510(K)
K
83
4539
AXIPAC II
Cleared 510(K)
K
84
2459
SITE GILLS STYLE I/A HANDPIECE
Cleared 510(K)
K
83
2327
SILA CLEAN 20/20
Cleared 510(K)
K
84
1273
ACCOMMOTRAC VISION TRAINER
Cleared 510(K)
K
84
1652
OCULAR PRESSURE APPLICATOR
Cleared 510(K)
K
84
1316
FLATPACK CARRYING CASE
Cleared 510(K)
K
84
0430
SUN-LITE WHITE SLIT
Cleared 510(K)
K
84
0427
SUN-LITE BLUE SPOT
Cleared 510(K)
K
84
0428
SUN-LITE PEN LIGHT
Cleared 510(K)
K
83
3024
OFTALMOGRAF
Cleared 510(K)
K
84
0493
SURG A STAT FINE TIP 5
Cleared 510(K)
K
83
2589
ELMED WMC 10 AND BC 50 M/M
Cleared 510(K)
K
84
0456
SUN-LITE 1
Cleared 510(K)
K
84
0429
SUN-LITE ONE MILLIMETER
Cleared 510(K)
K
84
0982
LASER MIRROR
Cleared 510(K)
K
83
2938
OCUTOME PARATUBING SET
Cleared 510(K)
K
83
2477
OCULOPRESSOR
Cleared 510(K)
K
83
2461
POLYCORE
Cleared 510(K)
K
83
2085
LENSOMETER
Cleared 510(K)
K
83
0737
JERMYN OCCLUDERS KIT
Cleared 510(K)
K
82
2542
POLYCORE
Cleared 510(K)
K
82
2541
VISIOPAL 75
Cleared 510(K)
K
82
2429
SINGLE VISION POWER LENS
Cleared 510(K)
K
82
2431
SUNGLASS & SAFETY PLANO LENS
Cleared 510(K)
K
82
2430
KRYPTOX-ROUND SEGMENT BIFOCAL
Cleared 510(K)
K
82
2529
SPECIAL EYE MIRROR
Cleared 510(K)
K
82
2125
MODEL 57000 NASO-CONJUNCTIVA ISOL. MASK
Cleared 510(K)
K
81
2015
GLAUKON
Cleared 510(K)
K
81
3483
OMS ANTERIOR CHAMBER INFUSION NEEDLE
Cleared 510(K)
K
81
0400
GLYCERINE DEHYDRATION UNIT
Cleared 510(K)
K
81
1117
EYE CARE TRAY
Cleared 510(K)
K
80
2881
ABSELE* ABSORBABLE BONE SEALANT
Cleared 510(K)
K
80
2691
OCCUPAK CAT.#200-0538
Cleared 510(K)
K
77
2228
ALSITE MAGNIVISION
Cleared 510(K)
K
77
2055
PENTAX F.O.-IT OBSERVER SCOPE
Cleared 510(K)
K
77
0728
INTRAOCULAR LENS
Cleared 510(K)
K
76
1178
ETO METHOD - STERILIZE INTRAOCULAR LENS
Cleared 510(K)
N
17
796
BRYREL SYRUP
APWD
PMA Approval
N
17
397
ACEPTOPLAST CONTACT LENS
APWD
PMA Approval
N
17
622
FLOURESCEIN SODIUM OPHTHALMIC STRIPS
APCV
PMA Approval
Subpart B—Diagnostic Devices
CFR Sub-Part
Subpart D—Prosthetic Devices
CFR Sub-Part
Subpart E—Surgical Devices
CFR Sub-Part
Subpart F—General Hospital and Personal Use Therapeutic Devices
CFR Sub-Part
Subpart F—Therapeutic Devices
CFR Sub-Part
Orthopedic
Review Panel
Pathology
Review Panel
Physical Medicine
Review Panel
Radiology
Review Panel
General and Plastic Surgery
Review Panel
Toxicology
Review Panel
Medical Genetics
Review Panel
Unknown
Review Panel
Last synced on 25 January 2026 at 3:41 am
OP
/
OP-misc
/
no-product-code
/
P980040
View Source
SENSAR SOFT ACRYLIC INTRAOCULAR LENSES
Page Type
PMA Approval
PDF
PDF
* The FDA doesn't provide PDFs for all submissions.
Applicant
Johnson & Johnson Surgical Vision, Inc.
Trade Name
SENSAR SOFT ACRYLIC UV-LIGHT ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS
Generic Name
intraocular lens
Decision Date
2/3/2000
Days to Decision
490 days
Decision Code
APPR
FDA Decision
Approval
FDA Browser
by
Innolitics
Anesthesiology
Cardiovascular
Chemistry
Dental
Ear, Nose, Throat
Gastroenterology and Urology
General Hospital
Hematology
Immunology
Microbiology
Neurology
Obstetrical and Gynecological
Ophthalmic
Miscellaneous
OGO
Intraocular Pressure Lowering Implant
QQU
Digital Therapy Device For Amblyopia
HPX
Lens, Contact (Polymethylmethacrylate)
LOG
Catheter, Balloon For Retinal Reattachment
LOH
System, Identification, Contact Lens
LOI
Laser, Neodymium:Yag, Ophthalmic For Uses Other Than Posterior Capsulotomy & Cutting Pupillary
LQB
Medical Computers And Software For Ophthalmic Use
LQE
Implant, Corneal, Refractive
LXQ
Cup, Eye
LYX
Media, Corneal Storage
LZQ
Tissue Adhesive For Ophthalmic Use
LZR
Ultrasound, Cyclodestructive
LZS
Excimer Laser System
LZU
Plug, Punctum
MRJ
Ring, Endocapsular
MSI
Solution, Cleaning / Lubricating, Artificial Eye
MTA
Lens, Intraocular, Phakic
MUR
Graft, Sclera, Reinforcement
MWD
Electrosurgical, Radio Frequency, Refractive Correction
NBF
Prosthesis, Retinal
NCJ
Telescope, Implantable, Miniature
ODK
Refractive Corneal Implant
OKS
Lacrimal Stents And Intubation Sets
OTL
Femtosecond Laser System For Refractive Correction
OXW
Stimulator, Electrical, Transcutaneous, For Diabetic Retinopathy
PFZ
Ophthalmic Sealant
QBT
Artificial Iris
QIT
Daily Wear Soft Contact Lens To Reduce The Progression Of Myopia
QCW
Corneal Storage Media With Preservatives Including Anti-Fungal
SAX
Home Monitoring Ophthalmic Optical Coherence Tomography (Oct) Imaging Device
QQJ
Applicator, Negative Pressure, External, Ocular
SDE
Light Based Device For Dry Age-Related Macular Degeneration
QUR
Prescription Spectacle Lenses To Reduce The Progression Of Myopia
Submissions with No Product Code
K
87
1326
DROP MATE
K
87
0905
SURE DROP
K
86
3662
OPHTHALMIC SURGICAL DRAPE
K
86
3666
THE SAVER KIT
K
86
1415
CANON AUTO REF KERATOMETER RK-1
K
86
1163
XTAL X-800 SHADOWGRAPH
K
86
1333
ULTRA-VIOLET GOGGLETS
K
86
1028
SUPERLITE PENLIGHT
K
86
0928
EYEMETER
K
85
4872
VFI/VFE SYSTEM II
P
08
0010
TECNIS 3-Poece Multifocal
P
08
0010
Tecnis 3-piece Multifocal
P
81
0031
Sodium Hyaluronate Ophtalmic Viscoelastc Devices (OVD); Healon PRO, Healon5 PRO, and Healon DUet PRO Dual Pack
P
81
0031
HEALON SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVICES (OVD), HEALON5 SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVI
P
06
0011
RAYNER C-FLEX 570C, C-FLEX ASPHERIC 970C AND 600C ASPHERIC INTRAOCULAR LENSES
P
06
0011
RAYNER C-FLEX 570C, C-FLEX ASPHERIC 970C AND 600C ASPHERIC INTRAOCULAR LENSES
P
98
0040
SENSAR SOFT ACRYLIC INTRAOCULAR LENSES
P
98
0040
TECNIS 1- PIECE IOL WITH TECNIS ITEC, TECNIS MULTIFOCAL 1-PIECE IOL WITH THE TECNIS ITEC, AND TECNIS TORIC 1-PIECE IOL
P
06
0011
RAYNER C-FLEX 570C AND C-FLEX ASPHERIC 970C INTRAOCULAR LENSES
P
98
0040
TECNIS 1-PIECE IOL, MODEL:ZCB00,TECNIS MULTIFOCAL 1-PIECE IOL, MODEL:ZMB00,TECNIS TORIC 1-PIECE IOL,MODELS:ZCT150, ZCT22
P
98
0040
TECNIS 1 PIECE IOL WITH THE TECNIS ITEC PRELOADED DELIVERY SYSTEM); TECNIS MULTIFOCAL 1 PIECE IOL WITH THE TECNIS ITEC P
P
98
0040
TECNIS 1-PIECE LENS MODEL ZCB00; TECNIS MULTIFOCAL 1-PIECE LENS MODEL ZBM00, SENSAR 1-PIECE LENS MODEL AAB00; TECNIS 1-P
P
98
0040
SENSAR 1-PIECE LENS MODEL AAB00
P
98
0040
TECNIS 1-PIECE IOL WITH TECNIS ITEC PRELOADED DELIVERY SYSTEM, TECNIS MULTIFOCAL 1-PIECE IOL WITH THE TECNIS ITEC PRELOA
P
98
0040
TECNIS 1-PIECE LENS MODEL ZCB00; TECNIS MULTIFOCAL 1-PIECE LENS MODEL ZMB00; SENSAR 1-PIECE LENS MODEL AAB00; TECNIS 1-P
P
98
0040
TECNIS OPTIBLUE 1-PIECE IOL
P
98
0040
TECNIS 1-PIECE IOL TEDNIS OPTIBLUE 1-PIECE IOL, TECNIS MULTIFOCAL 1-PIECE IOL
P
98
0040
SENSAR ACRYLIC IOL, TECNIS 1-PIECE IOL, TECNIS OPTIBLUE 1-PIECE IOL, TECNIS MULTIFOCAL 1-PIECE IOL
P
99
0080
SILICONE POSTERIOD CHAMBER INTRAOCULAR LENS, MODEL Z9000 INTRAOCULAR LENS MD 911A
K
85
4764
LECTROSTILL DISTILLED WATER U.S.P.
K
85
4140
MODIFIED MYDRIATIC SPECTACLE
K
85
4169
PUPILSCAN
K
85
4256
KEELER AMOILS SURGICAL ASTIGOMETER
K
85
3631
POLY-SLEEVE
K
85
3061
MST MODEL #ARLG-5
K
85
3199
INTEGRITY EYE DROP GUIDE(MODIFICATION)
K
84
2814
PERMALID LINER PAK
K
84
2781
PERMALID PAK
K
85
2187
SITE INFUSION CONTACT LENS W/ILLUMINATOR
K
85
2229
STERILE EYE PACKS OR TRAYS
K
85
1908
INTEGRITY EYE DROP GUIDE
K
85
0649
ABSORBABLE INTRACANALICULAR COLLAGEN IMPLANT
K
85
1008
ELECTRIC LIFT TABLE-OPHTHALMIC
K
85
0962
OPHTHALMIC DROPPER BOTTLES
K
84
1430
LASERSPEC
K
84
1896
EZ EYE DROP AID
K
84
3345
AGL400 ARGON LASER SYSTEM-KRL500 KRYPTON
K
83
4539
AXIPAC II
K
84
2459
SITE GILLS STYLE I/A HANDPIECE
K
83
2327
SILA CLEAN 20/20
K
84
1273
ACCOMMOTRAC VISION TRAINER
K
84
1652
OCULAR PRESSURE APPLICATOR
K
84
1316
FLATPACK CARRYING CASE
K
84
0430
SUN-LITE WHITE SLIT
K
84
0427
SUN-LITE BLUE SPOT
K
84
0428
SUN-LITE PEN LIGHT
K
83
3024
OFTALMOGRAF
K
84
0493
SURG A STAT FINE TIP 5
K
83
2589
ELMED WMC 10 AND BC 50 M/M
K
84
0456
SUN-LITE 1
K
84
0429
SUN-LITE ONE MILLIMETER
K
84
0982
LASER MIRROR
K
83
2938
OCUTOME PARATUBING SET
K
83
2477
OCULOPRESSOR
K
83
2461
POLYCORE
K
83
2085
LENSOMETER
K
83
0737
JERMYN OCCLUDERS KIT
K
82
2542
POLYCORE
K
82
2541
VISIOPAL 75
K
82
2429
SINGLE VISION POWER LENS
K
82
2431
SUNGLASS & SAFETY PLANO LENS
K
82
2430
KRYPTOX-ROUND SEGMENT BIFOCAL
K
82
2529
SPECIAL EYE MIRROR
K
82
2125
MODEL 57000 NASO-CONJUNCTIVA ISOL. MASK
K
81
2015
GLAUKON
K
81
3483
OMS ANTERIOR CHAMBER INFUSION NEEDLE
K
81
0400
GLYCERINE DEHYDRATION UNIT
K
81
1117
EYE CARE TRAY
K
80
2881
ABSELE* ABSORBABLE BONE SEALANT
K
80
2691
OCCUPAK CAT.#200-0538
K
77
2228
ALSITE MAGNIVISION
K
77
2055
PENTAX F.O.-IT OBSERVER SCOPE
K
77
0728
INTRAOCULAR LENS
K
76
1178
ETO METHOD - STERILIZE INTRAOCULAR LENS
N
17
796
BRYREL SYRUP
N
17
397
ACEPTOPLAST CONTACT LENS
N
17
622
FLOURESCEIN SODIUM OPHTHALMIC STRIPS
Subpart B—Diagnostic Devices
Subpart D—Prosthetic Devices
Subpart E—Surgical Devices
Subpart F—General Hospital and Personal Use Therapeutic Devices
Subpart F—Therapeutic Devices
Orthopedic
Pathology
Physical Medicine
Radiology
General and Plastic Surgery
Toxicology
Medical Genetics
Unknown
OP
/
OP-misc
/
no-product-code
/
P980040
View Source
SENSAR SOFT ACRYLIC INTRAOCULAR LENSES
Page Type
PMA Approval
PDF
PDF
* The FDA doesn't provide PDFs for all submissions.
Applicant
Johnson & Johnson Surgical Vision, Inc.
Trade Name
SENSAR SOFT ACRYLIC UV-LIGHT ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS
Generic Name
intraocular lens
Decision Date
2/3/2000
Days to Decision
490 days
Decision Code
APPR
FDA Decision
Approval