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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

Premarket Approvals (PMA)
2020 2021 2022 2023 2024 2025
1 0 0 0 0 0

MDR Year MDR Reports MDR Events
2020 211 211
2021 285 288
2022 513 513
2023 748 748
2024 1101 1156
2025 790 826

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 1287 1308
Scratched Material 381 383
Break 376 391
Material Discolored 250 250
Device Dislodged or Dislocated 178 178
Defective Device 170 170
Crack 134 134
Unstable 116 116
Malposition of Device 94 94
Material Split, Cut or Torn 90 91
Device Difficult to Setup or Prepare 66 67
Failure to Eject 61 61
Appropriate Term/Code Not Available 58 58
Material Fragmentation 55 55
Failure to Advance 48 50
Device Contamination with Chemical or Other Material 47 47
Mechanical Jam 46 47
Material Opacification 44 44
Device Damaged by Another Device 40 40
Failure to Deliver 40 40
Material Twisted/Bent 36 36
Ejection Problem 35 35
Defective Component 32 32
Contamination 30 31
Inaccurate Delivery 28 28
Mechanical Problem 26 27
Product Quality Problem 26 26
Unintended Movement 22 22
Insufficient Information 22 22
Material Deformation 20 20
Difficult to Fold, Unfold or Collapse 19 19
Failure to Unfold or Unwrap 19 19
Operating System Becomes Nonfunctional 15 15
Application Program Problem: Power Calculation Error 12 12
Failure to Fold 12 12
Physical Resistance/Sticking 12 12
Optical Decentration 11 11
Unintended Ejection 10 10
Use of Device Problem 10 10
Delivered as Unsterile Product 9 9
Difficult to Insert 9 9
Device Markings/Labelling Problem 9 9
Particulates 9 9
Device Contaminated During Manufacture or Shipping 8 8
Manufacturing, Packaging or Shipping Problem 8 8
Failure to Align 8 8
Application Program Problem: Dose Calculation Error 8 8
Patient-Device Incompatibility 7 7
Positioning Problem 7 7
Device Damaged Prior to Use 7 7

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1159 1193
Blurred Vision 769 774
Insufficient Information 740 740
Visual Impairment 703 709
Visual Disturbances 398 400
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 184 186
Halo 132 132
Capsular Bag Tear 83 84
Corneal Edema 64 64
Eye Injury 62 63
No Known Impact Or Consequence To Patient 55 55
Eye Pain 42 42
Inflammation 40 40
No Code Available 38 38
Dry Eye(s) 36 37
Discomfort 32 32
Vitreous Floaters 31 31
Headache 29 29
Intraocular Pressure Increased 27 27
Endophthalmitis 22 22
Toxic Anterior Segment Syndrome (TASS) 16 16
Macular Edema 15 15
Red Eye(s) 14 14
Zonular Dehiscence 14 14
No Consequences Or Impact To Patient 12 15
Uveitis 10 10
Loss of Vision 10 10
Dizziness 10 10
Flashers 10 10
Excessive Tear Production 9 9
Vitreous Loss 9 9
Hypopyon 9 9
Failure of Implant 9 9
Fibrosis 8 8
Therapeutic Effects, Unexpected 7 7
Swelling/ Edema 7 8
Unspecified Eye / Vision Problem 7 7
Foreign Body Sensation in Eye 7 7
Conjunctivitis 6 6
Retinal Detachment 6 6
Corneal Clouding/Hazing 5 5
Nausea 5 5
Itching Sensation 4 4
Adhesion(s) 4 4
Vitrectomy 4 4
Pain 4 4
Hyperemia 4 4
No Information 4 4
Eye Infections 4 4
Vitreous Detachment 4 4

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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