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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)
2020 2021 2022 2023 2024 2025
49 53 34 29 35 0

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

Device Problems MDRs with this Device Problem Events in those MDRs
Break 3253 4550
Adverse Event Without Identified Device or Use Problem 2921 3056
Scratched Material 1476 1582
Material Split, Cut or Torn 966 969
Crack 885 978
Defective Device 763 763
Failure to Eject 690 690
Material Fragmentation 467 475
Contamination 418 429
Use of Device Problem 404 406
Failure to Advance 378 378
Material Opacification 370 372
Inaccurate Delivery 352 352
Device Dislodged or Dislocated 347 347
Appropriate Term/Code Not Available 335 337
Device Damaged by Another Device 259 305
Ejection Problem 248 256
Difficult to Fold, Unfold or Collapse 243 247
Mechanical Jam 239 246
Device Contamination with Chemical or Other Material 229 229
Off-Label Use 228 228
Defective Component 200 315
Failure to Unfold or Unwrap 175 175
Physical Resistance/Sticking 174 178
Device Difficult to Setup or Prepare 167 173
Failure to Fold 155 156
Material Twisted/Bent 148 148
Insufficient Information 122 122
Mechanical Problem 118 119
Material Integrity Problem 97 97
Difficult to Advance 91 91
Unintended Ejection 87 87
Malposition of Device 84 84
Device Contaminated During Manufacture or Shipping 82 82
Material Discolored 82 82
Unintended Movement 74 74
Delivered as Unsterile Product 72 73
Operating System Becomes Nonfunctional 70 70
Sharp Edges 69 69
Difficult to Insert 66 67
Material Deformation 60 60
No Apparent Adverse Event 58 58
Material Too Rigid or Stiff 50 50
Manufacturing, Packaging or Shipping Problem 49 50
Device Appears to Trigger Rejection 49 49
Device Handling Problem 49 49
Optical Problem 48 48
Unstable 44 44
Particulates 43 43
Product Quality Problem 43 43

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 6626 7338
Insufficient Information 2524 2557
Visual Impairment 1249 1255
Blurred Vision 857 864
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 817 880
Visual Disturbances 754 766
Capsular Bag Tear 746 756
No Code Available 630 630
Failure of Implant 577 577
No Known Impact Or Consequence To Patient 400 579
No Consequences Or Impact To Patient 367 1428
Eye Injury 361 367
Halo 243 244
Inflammation 207 207
Corneal Edema 192 192
Endophthalmitis 138 145
Vitrectomy 129 129
Eye Pain 113 113
Intraocular Pressure Increased 103 151
Toxic Anterior Segment Syndrome (TASS) 99 99
Discomfort 88 89
Uveitis 64 113
Therapeutic Effects, Unexpected 61 61
Flashers 60 61
Zonular Dehiscence 59 59
Dry Eye(s) 57 58
Macular Edema 55 103
Vitreous Floaters 47 48
No Patient Involvement 41 41
Retinal Detachment 41 89
Vitreous Loss 39 39
Red Eye(s) 37 37
Unspecified Eye / Vision Problem 36 38
Iritis 33 33
Fibrosis 30 30
Hyphema 30 31
Hypopyon 26 26
Glaucoma 24 24
Headache 23 23
Pain 23 23
Vitreous Hemorrhage 22 22
Foreign Body Sensation in Eye 22 22
Eye Infections 21 22
Swelling/ Edema 21 21
Hemorrhage/Bleeding 21 21
Corneal Clouding/Hazing 20 20
Foreign Body In Patient 20 20
Prolapse 18 18
Hyperemia 18 18
No Information 17 17

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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