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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 24

MDR Year MDR Reports MDR Events
2019 3086 3603
2020 1981 3096
2021 2925 3096
2022 3290 3290
2023 3909 3957
2024 1697 1921

Device Problems MDRs with this Device Problem Events in those MDRs
Break 3556 5083
Adverse Event Without Identified Device or Use Problem 3419 3492
Scratched Material 1467 1537
Material Split, Cut or Torn 910 910
Crack 880 1024
Defective Device 753 753
Failure to Eject 621 621
Contamination 493 493
Material Fragmentation 421 425
Material Opacification 416 416
Appropriate Term/Code Not Available 388 390
Device Dislodged or Dislocated 376 376
Use of Device Problem 361 362
Inaccurate Delivery 350 350
Failure to Advance 333 333
Device Contamination with Chemical or Other Material 244 244
Difficult to Fold, Unfold or Collapse 234 235
Mechanical Jam 213 214
Off-Label Use 206 206
Device Damaged by Another Device 204 250
Defective Component 200 315
Ejection Problem 198 198
Failure to Unfold or Unwrap 197 197
Physical Resistance/Sticking 193 193
Material Twisted/Bent 187 187
No Apparent Adverse Event 163 163
Unintended Movement 158 158
Failure to Fold 157 157
Device Difficult to Setup or Prepare 128 129
Contamination /Decontamination Problem 122 122
Mechanical Problem 109 110
Insufficient Information 100 100
Material Deformation 87 87
Difficult to Advance 87 87
Malposition of Device 86 86
Device Contaminated During Manufacture or Shipping 84 84
Material Integrity Problem 82 82
Unintended Ejection 79 79
Material Discolored 71 71
Difficult to Insert 71 71
Sharp Edges 66 66
Device Handling Problem 64 64
Delivered as Unsterile Product 64 64
Operating System Becomes Nonfunctional 63 63
Product Quality Problem 61 61
Positioning Problem 59 59
Material Too Rigid or Stiff 58 58
Improper or Incorrect Procedure or Method 51 51
Calcified 50 50
Optical Problem 50 50
Device Appears to Trigger Rejection 49 49
Premature Activation 46 46
Unstable 46 46
Separation Problem 44 44
Patient-Device Incompatibility 43 43
Particulates 41 41
Fracture 41 41
Manufacturing, Packaging or Shipping Problem 40 40
Device Markings/Labelling Problem 35 35
Activation, Positioning or Separation Problem 34 34
Optical Distortion 31 31
Detachment of Device or Device Component 25 25
Device Damaged Prior to Use 25 25
Incorrect, Inadequate or Imprecise Result or Readings 22 22
Entrapment of Device 22 22
Unexpected Therapeutic Results 21 21
Therapeutic or Diagnostic Output Failure 20 43
Structural Problem 19 19
Failure to Align 17 17
Failure to Deliver 17 17
Optical Decentration 17 17
Material Rupture 16 16
Inadequacy of Device Shape and/or Size 14 14
Component Missing 14 14
Application Program Problem: Dose Calculation Error 14 14
Misfocusing 12 12
Inaccurate Information 12 12
Activation Problem 12 12
Dent in Material 11 11
Contamination of Device Ingredient or Reagent 10 10
Misassembled 10 10
Positioning Failure 10 10
Patient Device Interaction Problem 9 9
Packaging Problem 8 8
Deformation Due to Compressive Stress 7 7
Material Separation 7 7
Labelling, Instructions for Use or Training Problem 6 6
Device Contamination with Body Fluid 5 5
Output Problem 5 5
Device Fell 5 5
Activation Failure 4 4
Material Protrusion/Extrusion 4 4
Human-Device Interface Problem 4 4
Material Puncture/Hole 4 4
Loose or Intermittent Connection 4 4
Material Frayed 4 4
Migration or Expulsion of Device 4 4
Nonstandard Device 3 3
Material Disintegration 3 3
Difficult or Delayed Positioning 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 5966 6151
Insufficient Information 2010 2043
No Known Impact Or Consequence To Patient 1402 1587
No Code Available 1375 1375
Visual Impairment 1319 1324
Blurred Vision 918 922
Capsular Bag Tear 844 845
No Consequences Or Impact To Patient 805 2377
Visual Disturbances 800 805
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 766 816
Failure of Implant 555 555
Eye Injury 335 340
No Patient Involvement 309 309
Vitrectomy 308 308
Halo 250 250
Inflammation 234 234
Corneal Edema 209 209
Endophthalmitis 168 168
Intraocular Pressure Increased 105 153
Discomfort 90 90
Toxic Anterior Segment Syndrome (TASS) 88 88
Eye Pain 86 86
Therapeutic Effects, Unexpected 63 63
Uveitis 61 109
Dry Eye(s) 61 62
Macular Edema 59 107
Zonular Dehiscence 55 55
Flashers 54 55
No Information 49 49
Vitreous Floaters 47 48
Red Eye(s) 44 44
Pain 42 42
Vitreous Loss 42 42
Retinal Detachment 38 86
Iritis 34 34
Unspecified Eye / Vision Problem 34 35
Foreign Body In Patient 33 33
Glaucoma 31 31
Hyphema 30 30
Hemorrhage/Bleeding 29 29
Fibrosis 29 29
Rupture 29 29
Headache 26 26
Corneal Clouding/Hazing 25 25
Loss of Vision 25 25
Vitreous Hemorrhage 24 24
Hypopyon 24 24
Foreign Body Sensation in Eye 22 22
Eye Infections 21 22
Swelling/ Edema 16 16
Unspecified Infection 16 16
Hyperemia 16 16
Prolapse 15 15
Excessive Tear Production 14 14
Dizziness 14 14
Vitreous Detachment 13 13
Capsular Contracture 13 13
Deposits 12 12
Irritation 12 12
Tissue Damage 12 12
Intraocular Infection 11 11
Conjunctivitis 10 10
Calcium Deposits/Calcification 10 10
Bacterial Infection 9 9
Edema 9 9
Hypersensitivity/Allergic reaction 9 9
UGH (Uveitis Glaucoma Hyphema) Syndrome 9 9
Therapeutic Response, Decreased 8 8
Keratitis 8 8
Nausea 8 8
Cataract 7 7
Corneal Decompensation 7 7
Intraocular Pressure Decreased 7 7
Ptosis 6 6
Adhesion(s) 6 54
Retinal Tear 6 6
Swelling 5 6
Wound Dehiscence 5 5
Patient Problem/Medical Problem 5 5
Complaint, Ill-Defined 5 5
Impaired Healing 5 5
Inadequate Pain Relief 4 4
Injury 4 4
Anxiety 4 4
UGH (Uveitis-Glaucoma-Hyphema) Syndrome 4 4
Vitritis 4 4
Discharge 4 4
Corneal Abrasion 4 4
Fever 4 4
Corneal Stromal Edema 4 4
Erythema 4 4
High Blood Pressure/ Hypertension 4 4
Itching Sensation 3 3
Scarring 3 3
Pupillary Block 3 3
Burning Sensation 3 3
Fungal Infection 3 3
Irritability 3 3
Blood Loss 3 3
Increased Sensitivity 3 3

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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