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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
Regulation Description Intraocular lens.
Product CodeMJP
Regulation Number 886.3600
Device Class 3

MDR Year MDR Reports MDR Events
2021 285 289
2022 513 520
2023 748 752
2024 1100 1158
2025 1676 1761

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 1537 1573
Break 472 488
Scratched Material 436 439
Material Discolored 263 263
Device Dislodged or Dislocated 221 221
Defective Device 160 162
Device Difficult to Setup or Prepare 136 137
Material Split, Cut or Torn 129 130
Unstable 122 123
Crack 122 122
Failure to Deliver 109 109
Malposition of Device 93 93
Material Twisted/Bent 85 85
Failure to Advance 79 81
Device Damaged by Another Device 62 62
Failure to Eject 61 61
Material Fragmentation 60 60
Product Quality Problem 59 59
Material Opacification 54 54
Appropriate Term/Code Not Available 50 50
Mechanical Jam 49 50
Inaccurate Delivery 45 45
Device Contamination with Chemical or Other Material 43 45
Ejection Problem 41 41
Contamination 37 38
Failure to Unfold or Unwrap 34 34
Material Deformation 34 34
Mechanical Problem 31 32
Defective Component 28 28
Failure to Fold 25 25
Insufficient Information 24 24
Difficult to Fold, Unfold or Collapse 21 21
Unintended Movement 20 20
Operating System Becomes Nonfunctional 18 18
Optical Decentration 16 16
Application Program Problem: Power Calculation Error 12 12
Manufacturing, Packaging or Shipping Problem 12 12
Physical Resistance/Sticking 11 12
Application Program Problem: Dose Calculation Error 11 11
Delivered as Unsterile Product 11 11
Unintended Ejection 10 10
Difficult to Insert 9 9
Use of Device Problem 9 10
Dent in Material 9 9
Particulates 9 9
Device Contaminated During Manufacture or Shipping 8 8
Device Damaged Prior to Use 8 8
Failure to Align 8 8
Device Markings/Labelling Problem 8 8
Activation Problem 6 6

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1403 1447
Insufficient Information 1012 1014
Blurred Vision 952 961
Visual Impairment 851 864
Visual Disturbances 480 486
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 197 201
Halo 131 134
Capsular Bag Tear 95 96
Corneal Edema 77 78
Eye Injury 72 73
Eye Pain 48 50
Dry Eye(s) 39 40
Vitreous Floaters 38 38
Inflammation 37 37
Discomfort 35 35
Intraocular Pressure Increased 32 32
Headache 32 33
Endophthalmitis 25 25
Toxic Anterior Segment Syndrome (TASS) 23 23
Macular Edema 17 17
Red Eye(s) 16 18
Dizziness 15 15
Zonular Dehiscence 15 15
Foreign Body Sensation in Eye 14 14
Excessive Tear Production 11 11
Flashers 11 11
Uveitis 10 10
Hypopyon 10 10
Fibrosis 9 9
Loss of Vision 9 9
Swelling/ Edema 8 9
Unspecified Eye / Vision Problem 8 8
Conjunctivitis 8 8
Vitreous Loss 8 8
Retinal Detachment 6 6
Failure of Implant 6 8
Corneal Clouding/Hazing 5 5
Iritis 5 5
Nausea 5 6
Prolapse 5 5
Keratitis 4 4
Itching Sensation 4 4
Retinal Degeneration 4 4
Adhesion(s) 4 4
Vitreous Detachment 4 4
Eye Infections 4 4
No Code Available 4 4
Hyperemia 3 3
No Consequences Or Impact To Patient 3 6
Corneal Abrasion 3 3

Recalls
Manufacturer Recall Class Date Posted
1 Johnson & Johnson Surgical Vision Inc II Oct-04-2021
2 Johnson & Johnson Surgical Vision Inc II Mar-03-2021
3 Johnson & Johnson Surgical Vision, Inc. II Jan-16-2024
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