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U.S. Department of Health and Human Services

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

Premarket Approvals (PMA)
2019 2020 2021 2022 2023 2024
57 49 53 34 29 29

MDR Year MDR Reports MDR Events
2019 3086 3603
2020 1981 3096
2021 2925 3096
2022 3290 3290
2023 3909 3957
2024 2138 2602

Device Problems MDRs with this Device Problem Events in those MDRs
Break 3623 5226
Adverse Event Without Identified Device or Use Problem 3500 3600
Scratched Material 1538 1614
Material Split, Cut or Torn 943 945
Crack 921 1069
Defective Device 776 776
Failure to Eject 676 676
Contamination 511 517
Material Fragmentation 438 443
Material Opacification 420 420
Appropriate Term/Code Not Available 397 399
Device Dislodged or Dislocated 385 385
Use of Device Problem 382 383
Inaccurate Delivery 351 351
Failure to Advance 347 347
Device Contamination with Chemical or Other Material 245 245
Difficult to Fold, Unfold or Collapse 242 245
Mechanical Jam 226 229
Ejection Problem 218 223
Off-Label Use 213 213
Device Damaged by Another Device 212 258
Defective Component 204 319
Physical Resistance/Sticking 200 200
Failure to Unfold or Unwrap 200 200
Material Twisted/Bent 190 190
No Apparent Adverse Event 163 163
Failure to Fold 162 163
Unintended Movement 158 158
Device Difficult to Setup or Prepare 134 135
Insufficient Information 126 126
Contamination /Decontamination Problem 122 122
Mechanical Problem 114 115
Malposition of Device 94 94
Material Deformation 93 93
Material Integrity Problem 90 90
Difficult to Advance 88 88
Device Contaminated During Manufacture or Shipping 84 84
Unintended Ejection 83 83
Material Discolored 79 79
Difficult to Insert 74 75
Delivered as Unsterile Product 67 68
Sharp Edges 66 66
Operating System Becomes Nonfunctional 65 65
Device Handling Problem 64 64
Product Quality Problem 61 61
Positioning Problem 59 59
Material Too Rigid or Stiff 59 59
Improper or Incorrect Procedure or Method 52 52
Optical Problem 51 51
Calcified 50 50

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 6153 6495
Insufficient Information 2153 2186
No Known Impact Or Consequence To Patient 1402 1587
No Code Available 1375 1375
Visual Impairment 1374 1379
Blurred Vision 939 945
Capsular Bag Tear 864 869
Visual Disturbances 824 830
No Consequences Or Impact To Patient 805 2377
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 785 846
Failure of Implant 571 571
Eye Injury 357 362
No Patient Involvement 309 309
Vitrectomy 308 308
Halo 258 259
Inflammation 250 250
Corneal Edema 215 215
Endophthalmitis 173 175
Intraocular Pressure Increased 108 156
Eye Pain 97 97
Discomfort 91 91
Toxic Anterior Segment Syndrome (TASS) 90 90
Dry Eye(s) 64 65
Macular Edema 63 111
Therapeutic Effects, Unexpected 63 63
Uveitis 61 109
Zonular Dehiscence 56 56
Flashers 54 55
No Information 49 49
Vitreous Floaters 47 48
Red Eye(s) 44 44
Vitreous Loss 43 43
Pain 43 43
Retinal Detachment 42 90
Unspecified Eye / Vision Problem 35 37
Iritis 34 34
Hyphema 34 35
Foreign Body In Patient 33 33
Glaucoma 31 31
Hemorrhage/Bleeding 30 30
Fibrosis 30 30
Rupture 29 29
Loss of Vision 28 28
Headache 27 27
Hypopyon 26 26
Corneal Clouding/Hazing 26 26
Vitreous Hemorrhage 24 24
Foreign Body Sensation in Eye 22 22
Eye Infections 21 22
Swelling/ Edema 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
6 Tekia, Inc. II Dec-17-2019
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