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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 37

MDR Year MDR Reports MDR Events
2020 1981 3096
2021 2925 3097
2022 3290 3299
2023 3906 3955
2024 3197 4162
2025 3263 4426

Device Problems MDRs with this Device Problem Events in those MDRs
Break 3975 5603
Adverse Event Without Identified Device or Use Problem 3310 3552
Scratched Material 1860 2011
Material Split, Cut or Torn 1289 1296
Crack 1034 1158
Defective Device 792 792
Failure to Eject 738 738
Failure to Advance 549 550
Material Fragmentation 536 556
Device Difficult to Setup or Prepare 525 535
Contamination 490 516
Use of Device Problem 464 468
Material Twisted/Bent 448 448
Material Opacification 421 425
Device Dislodged or Dislocated 420 423
Inaccurate Delivery 407 407
Device Damaged by Another Device 403 449
Appropriate Term/Code Not Available 355 359
Ejection Problem 347 371
Failure to Deliver 301 301
Mechanical Jam 289 300
Failure to Unfold or Unwrap 278 278
Difficult to Fold, Unfold or Collapse 271 277
Off-Label Use 254 254
Device Contamination with Chemical or Other Material 232 232
Failure to Fold 224 225
Defective Component 222 338
Physical Resistance/Sticking 195 208
Insufficient Information 189 189
Material Deformation 143 143
Material Discolored 137 137
Mechanical Problem 132 134
Material Integrity Problem 129 129
Product Quality Problem 125 130
Difficult to Advance 97 97
Malposition of Device 92 92
Unintended Ejection 90 90
Delivered as Unsterile Product 84 85
Device Contaminated During Manufacture or Shipping 82 82
Operating System Becomes Nonfunctional 80 81
Difficult to Insert 78 80
Unintended Movement 74 74
Sharp Edges 71 71
Contamination /Decontamination Problem 71 71
Manufacturing, Packaging or Shipping Problem 67 69
No Apparent Adverse Event 67 67
Particulates 56 56
Optical Problem 52 52
Material Too Rigid or Stiff 50 50
Device Handling Problem 49 49

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 8286 9768
Insufficient Information 3685 3719
Visual Impairment 1502 1515
Blurred Vision 1005 1024
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 960 1047
Visual Disturbances 906 940
Capsular Bag Tear 826 841
Failure of Implant 633 639
No Code Available 630 630
Eye Injury 440 455
No Known Impact Or Consequence To Patient 400 579
No Consequences Or Impact To Patient 367 1428
Halo 267 270
Corneal Edema 238 240
Inflammation 228 229
Toxic Anterior Segment Syndrome (TASS) 158 158
Endophthalmitis 156 163
Eye Pain 137 138
Intraocular Pressure Increased 131 179
Vitrectomy 129 129
Discomfort 96 99
Uveitis 79 129
Flashers 71 74
Zonular Dehiscence 68 68
Dry Eye(s) 67 70
Macular Edema 62 110
Therapeutic Effects, Unexpected 61 61
Vitreous Floaters 58 59
Retinal Detachment 49 98
Hypopyon 46 46
Red Eye(s) 45 45
Unspecified Eye / Vision Problem 45 49
Vitreous Loss 42 42
No Patient Involvement 41 41
Hyphema 37 38
Iritis 35 35
Headache 33 36
Glaucoma 33 33
Fibrosis 32 32
Swelling/ Edema 27 27
Foreign Body Sensation in Eye 27 28
Eye Infections 26 31
Pain 25 26
Vitreous Hemorrhage 24 24
Hemorrhage/Bleeding 22 22
Keratitis 21 21
Foreign Body In Patient 21 21
Corneal Clouding/Hazing 21 21
Loss of Vision 20 20
Prolapse 19 19

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. III Aug-26-2025
4 Bausch & Lomb Surgical, Inc. I May-02-2025
5 Bausch & Lomb Surgical, Inc. II Jul-10-2020
6 Johnson & Johnson Surgical Vision, Inc. II Aug-03-2023
7 Rayner Intraocular Lenses Ltd II Jul-06-2022
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