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TPLC
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show TPLC since
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2024
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Device
lens, intraocular, toric optics
Product Code
MJP
Regulation Number
886.3600
Device Class
3
Premarket Approvals (PMA)
2016
2017
2018
2019
2020
2021
2022
2023
2024
4
1
1
0
1
0
0
0
0
MDR Year
MDR Reports
MDR Events
2016
285
285
2017
311
311
2018
364
364
2019
382
382
2020
211
211
2021
285
288
2022
511
511
2023
748
748
2024
234
234
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
1018
1018
Scratched Material
298
298
Break
291
294
Device Dislodged or Dislocated
191
191
Appropriate Term/Code Not Available
173
173
Insufficient Information
168
168
Defective Device
144
144
Device Operates Differently Than Expected
133
133
Crack
122
122
Malposition of Device
108
108
Unstable
97
97
Device Contamination with Chemical or Other Material
59
59
Patient-Device Incompatibility
48
48
Material Split, Cut or Torn
40
40
Mechanical Jam
35
35
Material Fragmentation
35
35
Unexpected Therapeutic Results
33
33
Defective Component
33
33
Positioning Problem
33
33
Unintended Movement
29
29
Failure to Advance
29
29
Material Opacification
29
29
Mechanical Problem
29
29
Inaccurate Delivery
24
24
Failure to Eject
23
23
Device Damaged by Another Device
21
21
Contamination
21
21
Ejection Problem
20
20
Contamination /Decontamination Problem
14
14
Difficult to Fold, Unfold or Collapse
14
14
Device Difficult to Setup or Prepare
14
14
Failure to Unfold or Unwrap
13
13
Failure to Align
12
12
Material Deformation
12
12
Operating System Becomes Nonfunctional
11
11
Device Markings/Labelling Problem
11
11
Therapeutic or Diagnostic Output Failure
11
11
Power Problem
11
11
Application Program Problem: Power Calculation Error
11
11
Migration or Expulsion of Device
11
11
Material Discolored
11
11
Torn Material
10
10
Physical Resistance/Sticking
10
10
Incorrect, Inadequate or Imprecise Result or Readings
9
9
Improper or Incorrect Procedure or Method
9
9
Nonstandard Device
8
8
Device Contaminated During Manufacture or Shipping
8
8
Material Twisted/Bent
8
8
Device Damaged Prior to Use
7
7
Migration
7
7
Overcorrection
7
7
Unintended Ejection
7
7
Component Missing
7
7
Device Slipped
7
7
Inadequacy of Device Shape and/or Size
6
6
Use of Device Problem
6
6
Difficult to Insert
6
6
Delivered as Unsterile Product
6
6
Application Program Problem: Dose Calculation Error
6
6
Output Problem
6
6
Material Integrity Problem
6
6
Manufacturing, Packaging or Shipping Problem
5
5
Device Displays Incorrect Message
5
5
Activation, Positioning or Separation Problem
5
5
Folded
4
4
Difficult to Advance
4
4
Optical Decentration
4
4
Failure to Fold
4
4
Device Inoperable
4
4
Material Too Rigid or Stiff
4
4
Out-Of-Box Failure
3
3
Optical Distortion
3
3
Optical Problem
3
3
Detachment of Device or Device Component
3
3
Structural Problem
3
3
Patient Device Interaction Problem
3
3
Optical Discoloration
2
2
Compatibility Problem
2
2
Sticking
2
2
Unable to Obtain Readings
2
2
Difficult to Remove
2
2
Off-Label Use
2
2
Incorrect Measurement
2
2
Particulates
2
2
Positioning Failure
2
2
Entrapment of Device
2
2
Component Falling
2
2
Device Alarm System
1
1
Failure To Adhere Or Bond
1
1
Bent
1
1
Calcified
1
1
Device Reprocessing Problem
1
1
Complete Blockage
1
1
Collapse
1
1
Degraded
1
1
Difficult or Delayed Positioning
1
1
Energy Output To Patient Tissue Incorrect
1
1
Energy Spectrum Incorrect
1
1
Fracture
1
1
Fogging
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Visual Impairment
678
678
Blurred Vision
647
647
No Clinical Signs, Symptoms or Conditions
574
574
Insufficient Information
335
335
No Known Impact Or Consequence To Patient
303
303
No Code Available
268
268
Visual Disturbances
265
265
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
149
149
Halo
106
106
Capsular Bag Tear
89
89
Inflammation
87
87
Failure of Implant
58
58
Corneal Edema
57
58
Endophthalmitis
57
57
Eye Injury
46
46
Loss of Vision
44
44
Dry Eye(s)
42
42
No Consequences Or Impact To Patient
37
40
Discomfort
35
35
Therapeutic Effects, Unexpected
31
31
Pain
29
31
No Information
25
25
Eye Pain
24
24
Intraocular Pressure Increased
23
23
Vitrectomy
22
22
Vitreous Floaters
21
21
Headache
21
21
Complaint, Ill-Defined
20
20
Red Eye(s)
18
19
Zonular Dehiscence
14
14
Hypopyon
13
13
Macular Edema
13
13
Uveitis
12
12
Foreign Body Sensation in Eye
11
11
Toxic Anterior Segment Syndrome (TASS)
11
11
No Patient Involvement
11
11
Fibrosis
10
10
Therapeutic Response, Decreased
10
10
Vitreous Loss
10
10
Dizziness
10
10
Excessive Tear Production
9
9
Flashers
9
9
Patient Problem/Medical Problem
9
9
Corneal Clouding/Hazing
8
8
Hyperemia
7
7
Conjunctivitis
7
7
Unspecified Infection
6
6
Rupture
6
6
Increased Sensitivity
6
6
Itching Sensation
6
6
Vitreous Detachment
6
6
Adhesion(s)
5
5
Capsular Contracture
4
4
Edema
4
4
Hemorrhage/Bleeding
4
4
Iritis
4
4
Nausea
4
4
Scar Tissue
4
4
Foreign Body In Patient
4
4
Eye Infections
4
4
Unspecified Eye / Vision Problem
4
4
Swelling/ Edema
3
3
Toxicity
3
3
Scarring
3
3
Retinal Detachment
3
3
Keratitis
3
3
Burning Sensation
3
3
Glaucoma
3
3
Hypersensitivity/Allergic reaction
3
3
Erythema
3
3
Corneal Decompensation
3
3
Ecchymosis
2
2
Retinal Tear
2
2
Swelling
2
2
Impaired Healing
2
2
Inadequate Pain Relief
2
2
Reaction
2
2
Irritability
2
2
Prolapse
2
2
Decreased Sensitivity
2
2
Corneal Epithelial Microcysts
2
2
Anxiety
2
2
Device Embedded In Tissue or Plaque
2
2
Unspecified Nervous System Problem
1
1
UGH (Uveitis Glaucoma Hyphema) Syndrome
1
1
Intraocular Pressure Decreased
1
1
Fluid Discharge
1
1
Shaking/Tremors
1
1
Ambulation Difficulties
1
1
Confusion/ Disorientation
1
1
Blood Loss
1
1
Skin Inflammation
1
1
Depression
1
1
Joint Dislocation
1
1
Staphylococcus Aureus
1
1
Necrosis
1
1
Optical Nerve Damage
1
1
Perforation
1
1
Vitritis
1
1
Vertigo
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Bausch & Lomb Surgical, Inc.
II
Dec-02-2020
2
Johnson & Johnson Surgical Vision Inc
II
Oct-04-2021
3
Johnson & Johnson Surgical Vision Inc
II
Mar-03-2021
4
Johnson & Johnson Surgical Vision, Inc.
II
Jan-16-2024
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