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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 17

MDR Year MDR Reports MDR Events
2020 1981 3096
2021 2925 3096
2022 3290 3290
2023 3908 3956
2024 3201 4169
2025 1641 2282

Device Problems MDRs with this Device Problem Events in those MDRs
Break 3611 5094
Adverse Event Without Identified Device or Use Problem 3107 3285
Scratched Material 1703 1835
Material Split, Cut or Torn 1138 1143
Crack 969 1080
Defective Device 788 788
Failure to Eject 734 734
Material Fragmentation 505 520
Failure to Advance 462 463
Contamination 459 478
Use of Device Problem 438 440
Material Opacification 400 404
Device Dislodged or Dislocated 386 389
Inaccurate Delivery 379 379
Appropriate Term/Code Not Available 350 352
Device Damaged by Another Device 320 366
Device Difficult to Setup or Prepare 319 328
Ejection Problem 294 312
Material Twisted/Bent 293 293
Mechanical Jam 268 278
Difficult to Fold, Unfold or Collapse 262 267
Off-Label Use 247 247
Failure to Unfold or Unwrap 240 240
Device Contamination with Chemical or Other Material 229 229
Defective Component 220 335
Physical Resistance/Sticking 188 200
Failure to Fold 187 188
Insufficient Information 167 167
Failure to Deliver 149 149
Mechanical Problem 125 126
Material Discolored 123 123
Material Integrity Problem 115 115
Material Deformation 99 99
Difficult to Advance 96 96
Product Quality Problem 95 95
Unintended Ejection 89 89
Malposition of Device 87 87
Device Contaminated During Manufacture or Shipping 82 82
Delivered as Unsterile Product 80 81
Operating System Becomes Nonfunctional 78 79
Unintended Movement 74 74
Sharp Edges 71 71
Contamination /Decontamination Problem 69 69
Difficult to Insert 68 69
No Apparent Adverse Event 59 59
Manufacturing, Packaging or Shipping Problem 55 56
Material Too Rigid or Stiff 50 50
Device Appears to Trigger Rejection 49 49
Device Handling Problem 49 49
Optical Problem 49 49

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 7430 8591
Insufficient Information 3122 3155
Visual Impairment 1387 1400
Blurred Vision 927 940
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 901 977
Visual Disturbances 824 845
Capsular Bag Tear 785 795
No Code Available 630 630
Failure of Implant 606 606
Eye Injury 404 416
No Known Impact Or Consequence To Patient 400 579
No Consequences Or Impact To Patient 367 1428
Halo 255 256
Inflammation 221 221
Corneal Edema 219 221
Endophthalmitis 148 155
Toxic Anterior Segment Syndrome (TASS) 141 141
Vitrectomy 129 129
Eye Pain 126 126
Intraocular Pressure Increased 123 171
Discomfort 92 94
Uveitis 74 123
Flashers 69 71
Zonular Dehiscence 66 66
Dry Eye(s) 63 65
Therapeutic Effects, Unexpected 61 61
Macular Edema 59 107
Vitreous Floaters 53 54
Retinal Detachment 47 95
Vitreous Loss 42 42
Hypopyon 42 42
Red Eye(s) 41 41
No Patient Involvement 41 41
Unspecified Eye / Vision Problem 40 43
Hyphema 35 36
Iritis 33 33
Glaucoma 32 32
Fibrosis 31 31
Headache 27 29
Swelling/ Edema 26 26
Pain 25 26
Foreign Body Sensation in Eye 25 26
Vitreous Hemorrhage 23 23
Eye Infections 23 24
Keratitis 21 21
Hemorrhage/Bleeding 21 21
Foreign Body In Patient 21 21
Corneal Clouding/Hazing 21 21
Prolapse 19 19
Loss of Vision 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. I May-02-2025
4 Bausch & Lomb Surgical, Inc. II Jul-10-2020
5 Johnson & Johnson Surgical Vision, Inc. II Aug-03-2023
6 Rayner Intraocular Lenses Ltd II Jul-06-2022
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