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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device lens, multifocal intraocular
Regulation Description Intraocular lens.
Product CodeMFK
Regulation Number 886.3600
Device Class 3

Premarket Approvals (PMA)
2021 2022 2023 2024 2025 2026
8 8 6 11 14 8

MDR Year MDR Reports MDR Events
2021 1205 1210
2022 1265 1277
2023 1047 1051
2024 975 1101
2025 936 1311
2026 461 777

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 3738 4136
Scratched Material 475 495
Break 472 539
Device Dislodged or Dislocated 200 203
Defective Device 147 147
Appropriate Device Problem Term/Code Not Available 140 141
Crack 120 125
Material Split, Cut or Torn 107 108
Device Difficult to Setup or Prepare 85 89
Material Opacification 83 86
Malposition of Device 68 68
Device Contamination with Chemical or Other Material 61 61
Material Deformation 58 58
Insufficient Device Problem Information 55 55
Mechanical Jam 51 54
Material Twisted/Bent 45 45
Ejection Problem 41 43
Failure to Advance 35 40
Failure to Eject 34 34
Failure to Deliver 33 33
Mechanical Problem 32 33
Material Fragmentation 31 31
Device Damaged by Another Device 28 28
Product Quality Problem 27 27
Material Discolored 26 26
Difficult to Fold, Unfold or Collapse 26 26
Defective Component 24 24
Optical Decentration 24 24
Unstable 22 22
Contamination 21 23
Operating System Becomes Nonfunctional 19 21
Inaccurate Delivery 17 17
Application Program Problem: Dose Calculation Error 17 17
Manufacturing, Packaging or Shipping Problem 15 15
Failure to Unfold or Unwrap 15 15
Failure to Fold 14 15
Physical Resistance/Sticking 14 14
Use of Device Problem 13 13
Incorrect, Inadequate or Imprecise Result or Readings 13 14
Particulates 11 11
Application Program Problem: Power Calculation Error 11 11
Device Damaged Prior to Use 9 9
Dent in Material 7 7
Device Markings/Labelling Problem 6 6
Difficult to Advance 6 6
Delivered as Unsterile Product 6 6
Failure to Align 6 6
Material Too Rigid or Stiff 5 8
Difficult to Insert 4 4
Positioning Failure 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
Blurred Vision 2074 2190
Visual Disturbances 1780 1889
Visual Impairment 1461 1509
Halo 1100 1173
No Clinical Signs, Symptoms or Conditions 1016 1174
Insufficient Information 748 748
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 411 426
Eye Injury 144 168
Dry Eye(s) 136 144
Discomfort 131 136
Eye Pain 106 111
Headache 85 86
Vitreous Floaters 83 83
Flashers 79 84
Posterior Capsule Opacification 78 86
Capsular Bag Tear 75 78
Corneal Edema 75 78
Intraocular Pressure Increased 55 57
Inflammation 52 53
Toxic Anterior Segment Syndrome (TASS) 51 51
Failure of Implant 37 38
Foreign Body Sensation in Eye 35 37
Unspecified Eye / Vision Problem 31 34
Diplopia/Double Vision 31 31
Macular Edema 30 31
Eye Irritation 27 27
Uveitis 21 21
Dizziness 20 20
Red Eye(s) 18 19
Hypopyon 17 17
Zonular Dehiscence 16 16
Endophthalmitis 14 14
Vitreous Detachment 12 13
Capsular Contracture 10 10
Excessive Tear Production 10 10
Swelling/ Edema 10 10
Nausea 9 9
Conjunctivitis 8 8
Corneal Abrasion 8 8
Prolapse 8 8
Retinal Tear 8 8
Fibrosis 7 7
Corneal Scar 7 8
Irritability 7 7
Loss of Vision 7 7
Retinal Degeneration 7 7
Photophobia 7 7
Corneal Clouding/Hazing 7 7
Anxiety 7 7
Retinal Detachment 6 6

Recalls
Manufacturer Recall Class Date Posted
1 Bausch & Lomb Surgical, Inc. I May-02-2025
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