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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device lens, intraocular, toric optics
Product CodeMJP
Regulation Number 886.3600
Device Class 3

Premarket Approvals (PMA)
2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024
0 0 0 0 2 5 5 4 1 1 0 1 0 0 0 0

MDR Year MDR Reports MDR Events
2014 86 86
2015 389 389
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 1092 1092
Break 306 309
Scratched Material 301 301
Device Dislodged or Dislocated 295 295
Insufficient Information 271 271
Device Operates Differently Than Expected 196 196
Appropriate Term/Code Not Available 192 192
Defective Device 149 149
Malposition of Device 124 124
Crack 122 122
Unstable 98 98
Device Contamination with Chemical or Other Material 60 60
Patient-Device Incompatibility 52 52
Positioning Problem 45 45
Material Split, Cut or Torn 40 40
Mechanical Jam 35 35
Unexpected Therapeutic Results 35 35
Material Fragmentation 35 35
Defective Component 33 33
Mechanical Problem 32 32
Material Opacification 31 31
Unintended Movement 30 30
Failure to Advance 29 29
Inaccurate Delivery 24 24
Failure to Eject 23 23
Device Damaged by Another Device 21 21
Nonstandard Device 21 21
Migration or Expulsion of Device 21 21
Contamination 21 21
Ejection Problem 20 20
Difficult to Fold, Unfold or Collapse 15 15
Device Difficult to Setup or Prepare 14 14
Contamination /Decontamination Problem 14 14
Failure to Align 13 13
Material Deformation 13 13
Therapeutic or Diagnostic Output Failure 13 13
Improper or Incorrect Procedure or Method 13 13
Failure to Unfold or Unwrap 13 13
Torn Material 12 12
Device Markings/Labelling Problem 12 12
Operating System Becomes Nonfunctional 11 11
Power Problem 11 11
Application Program Problem: Power Calculation Error 11 11
Material Discolored 11 11
Physical Resistance/Sticking 10 10
Overcorrection 9 9
Incorrect, Inadequate or Imprecise Result or Readings 9 9
Inadequacy of Device Shape and/or Size 8 8
Device Damaged Prior to Use 8 8
Component Missing 8 8
Material Integrity Problem 8 8
Material Twisted/Bent 8 8
Device Contaminated During Manufacture or Shipping 8 8
Migration 7 7
Device Slipped 7 7
Unintended Ejection 7 7
Difficult to Insert 6 6
Application Program Problem: Dose Calculation Error 6 6
Use of Device Problem 6 6
Delivered as Unsterile Product 6 6
Optical Problem 6 6
Output Problem 6 6
Activation, Positioning or Separation Problem 6 6
Detachment of Device or Device Component 5 5
Device Displays Incorrect Message 5 5
Manufacturing, Packaging or Shipping Problem 5 5
Difficult to Remove 5 5
Device Inoperable 5 5
Optical Decentration 5 5
Failure to Fold 4 4
Material Too Rigid or Stiff 4 4
Difficult to Advance 4 4
Structural Problem 4 4
Folded 4 4
Packaging Problem 4 4
Optical Distortion 3 3
Patient Device Interaction Problem 3 3
Material Rupture 3 3
Off-Label Use 3 3
Out-Of-Box Failure 3 3
Leak/Splash 3 3
Incorrect Measurement 2 2
Degraded 2 2
Positioning Failure 2 2
Entrapment of Device 2 2
Component Falling 2 2
Sticking 2 2
Particulates 2 2
Product Quality Problem 2 2
Unable to Obtain Readings 2 2
Compatibility Problem 2 2
Optical Discoloration 2 2
Mechanics Altered 2 2
Gas/Air Leak 1 1
Blocked Connection 1 1
Device Contamination With Biological Material 1 1
Component or Accessory Incompatibility 1 1
Device Issue 1 1
Wrinkled 1 1
Dent in Material 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Visual Impairment 782 782
Blurred Vision 709 709
No Clinical Signs, Symptoms or Conditions 574 574
No Known Impact Or Consequence To Patient 382 382
No Code Available 341 341
Insufficient Information 337 337
Visual Disturbances 290 290
Inflammation 154 154
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 149 149
Halo 110 110
Capsular Bag Tear 102 102
Endophthalmitis 101 101
Corneal Edema 60 61
Loss of Vision 59 59
Failure of Implant 58 58
Eye Injury 49 49
Dry Eye(s) 44 44
No Consequences Or Impact To Patient 40 43
Therapeutic Effects, Unexpected 39 39
Discomfort 38 38
No Information 36 36
Pain 36 38
Complaint, Ill-Defined 35 35
Vitrectomy 30 30
Intraocular Pressure Increased 27 27
Headache 27 27
Vitreous Floaters 24 24
Eye Pain 24 24
Hypopyon 23 23
Red Eye(s) 20 21
Macular Edema 17 17
Capsular Contracture 15 15
Zonular Dehiscence 15 15
Fibrosis 14 14
Foreign Body Sensation in Eye 14 14
Hyperemia 13 13
No Patient Involvement 13 13
Uveitis 12 12
Therapeutic Response, Decreased 11 11
Toxic Anterior Segment Syndrome (TASS) 11 11
Patient Problem/Medical Problem 10 10
Dizziness 10 10
Vitreous Loss 10 10
Flashers 10 10
Unspecified Infection 9 9
Excessive Tear Production 9 9
Hemorrhage/Bleeding 8 8
Corneal Clouding/Hazing 8 8
Conjunctivitis 7 7
Rupture 7 7
Vitreous Detachment 6 6
Foreign Body In Patient 6 6
Itching Sensation 6 6
Increased Sensitivity 6 6
Iritis 5 5
Adhesion(s) 5 5
Edema 5 5
Glaucoma 4 4
Keratitis 4 4
Nausea 4 4
Scar Tissue 4 4
Burning Sensation 4 4
Unspecified Eye / Vision Problem 4 4
Eye Infections 4 4
Swelling/ Edema 3 3
Anxiety 3 3
Toxicity 3 3
Depression 3 3
Disability 3 3
Scarring 3 3
Swelling 3 3
Retinal Detachment 3 3
Retinal Tear 3 3
Hypersensitivity/Allergic reaction 3 3
Corneal Decompensation 3 3
Erythema 3 3
Fatigue 3 3
Corneal Scar 2 2
Ecchymosis 2 2
Staphylococcus Aureus 2 2
Prolapse 2 2
Impaired Healing 2 2
Inadequate Pain Relief 2 2
Reaction 2 2
Irritability 2 2
Decreased Sensitivity 2 2
Fluid Discharge 2 2
Device Embedded In Tissue or Plaque 2 2
Corneal Epithelial Microcysts 2 2
Unspecified Nervous System Problem 1 1
Skin Inflammation 1 1
Shaking/Tremors 1 1
Sleep Dysfunction 1 1
Ambulation Difficulties 1 1
Confusion/ Disorientation 1 1
Blood Loss 1 1
Joint Dislocation 1 1
Discharge 1 1
Clouding, Central Corneal 1 1
UGH (Uveitis Glaucoma Hyphema) Syndrome 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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