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U.S. Department of Health and Human Services

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

Premarket Approvals (PMA)
2020 2021 2022 2023 2024 2025
49 53 34 29 35 7

MDR Year MDR Reports MDR Events
2020 1981 3096
2021 2925 3096
2022 3290 3290
2023 3908 3956
2024 3200 4168
2025 581 813

Device Problems MDRs with this Device Problem Events in those MDRs
Break 3383 4755
Adverse Event Without Identified Device or Use Problem 2987 3130
Scratched Material 1569 1690
Material Split, Cut or Torn 1020 1025
Crack 926 1024
Defective Device 785 785
Failure to Eject 729 729
Material Fragmentation 482 492
Contamination 428 442
Failure to Advance 422 423
Use of Device Problem 416 418
Material Opacification 376 379
Inaccurate Delivery 360 360
Device Dislodged or Dislocated 354 354
Appropriate Term/Code Not Available 343 345
Device Damaged by Another Device 277 323
Ejection Problem 266 281
Mechanical Jam 251 258
Difficult to Fold, Unfold or Collapse 247 252
Off-Label Use 232 232
Device Contamination with Chemical or Other Material 229 229
Defective Component 218 333
Device Difficult to Setup or Prepare 203 209
Material Twisted/Bent 198 198
Failure to Unfold or Unwrap 192 192
Physical Resistance/Sticking 178 184
Failure to Fold 167 168
Insufficient Information 126 126
Mechanical Problem 121 122
Material Integrity Problem 110 110
Difficult to Advance 96 96
Unintended Ejection 89 89
Material Discolored 88 88
Malposition of Device 87 87
Device Contaminated During Manufacture or Shipping 82 82
Delivered as Unsterile Product 76 77
Unintended Movement 74 74
Operating System Becomes Nonfunctional 72 72
Material Deformation 70 70
Sharp Edges 69 69
Difficult to Insert 66 67
No Apparent Adverse Event 58 58
Failure to Deliver 57 57
Product Quality Problem 54 54
Manufacturing, Packaging or Shipping Problem 53 54
Material Too Rigid or Stiff 50 50
Device Handling Problem 49 49
Device Appears to Trigger Rejection 49 49
Optical Problem 48 48
Unstable 45 45

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 6907 7795
Insufficient Information 2752 2785
Visual Impairment 1287 1295
Blurred Vision 884 892
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 829 895
Visual Disturbances 786 800
Capsular Bag Tear 756 766
No Code Available 630 630
Failure of Implant 586 586
No Known Impact Or Consequence To Patient 400 579
Eye Injury 379 389
No Consequences Or Impact To Patient 367 1428
Halo 246 247
Inflammation 214 214
Corneal Edema 197 197
Endophthalmitis 141 148
Vitrectomy 129 129
Eye Pain 117 117
Intraocular Pressure Increased 111 159
Toxic Anterior Segment Syndrome (TASS) 101 101
Discomfort 88 89
Uveitis 71 120
Flashers 66 67
Therapeutic Effects, Unexpected 61 61
Zonular Dehiscence 60 60
Macular Edema 57 105
Dry Eye(s) 57 58
Vitreous Floaters 50 51
No Patient Involvement 41 41
Red Eye(s) 41 41
Retinal Detachment 41 89
Vitreous Loss 41 41
Unspecified Eye / Vision Problem 40 43
Hyphema 34 35
Iritis 33 33
Fibrosis 30 30
Glaucoma 28 28
Hypopyon 26 26
Pain 24 25
Headache 23 23
Foreign Body Sensation in Eye 23 24
Eye Infections 22 23
Vitreous Hemorrhage 22 22
Hemorrhage/Bleeding 21 21
Swelling/ Edema 21 21
Foreign Body In Patient 20 20
Corneal Clouding/Hazing 20 20
Prolapse 18 18
Loss of Vision 18 18
Hyperemia 18 18

Recalls
Manufacturer Recall Class Date Posted
1 Alcon Laboratories Ireland, Ltd II Jun-17-2022
2 Alcon Research LLC II Jun-05-2020
3 Bausch & Lomb Surgical, Inc. II Jul-10-2020
4 Johnson & Johnson Surgical Vision, Inc. II Aug-03-2023
5 Rayner Intraocular Lenses Ltd II Jul-06-2022
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