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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)
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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