Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
Device intraocular lens
Product CodeHQL
Regulation Number 886.3600
Device Class 3

Premarket Approvals (PMA)
2018 2019 2020 2021 2022 2023
39 57 49 54 34 9

MDR Year MDR Reports MDR Events
2018 2501 2501
2019 3086 3603
2020 1982 3097
2021 2929 3100
2022 3300 3300
2023 1506 1554

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 3440 3488
Break 3022 4458
Scratched Material 1136 1200
Crack 785 927
Defective Device 543 543
Material Split, Cut or Torn 486 486
Appropriate Term/Code Not Available 422 422
Failure to Eject 410 410
Contamination 400 400
Material Opacification 382 382
Device Contamination with Chemical or Other Material 350 350
Inaccurate Delivery 345 345
Device Dislodged or Dislocated 322 322
Material Fragmentation 300 300
Failure to Advance 255 255
Unintended Movement 241 241
Use of Device Problem 224 224
No Apparent Adverse Event 217 217
Physical Resistance/Sticking 204 204
Failure to Unfold or Unwrap 200 200
Material Twisted/Bent 185 185
Difficult to Fold, Unfold or Collapse 181 181
Mechanical Jam 180 180
Contamination /Decontamination Problem 164 164
Insufficient Information 159 159
Defective Component 156 271
Device Damaged by Another Device 138 184
Off-Label Use 134 134
Failure to Fold 125 125
Device Operates Differently Than Expected 118 118
Material Deformation 117 117
Difficult to Advance 97 97
Inadequacy of Device Shape and/or Size 96 96
Mechanical Problem 89 89
Device Contaminated During Manufacture or Shipping 84 84
Malposition of Device 83 83
Positioning Problem 79 79
Material Integrity Problem 77 77
Patient-Device Incompatibility 75 75
Optical Problem 73 73
Separation Problem 67 67
Device Handling Problem 66 66
Difficult to Insert 65 65
Device Difficult to Setup or Prepare 65 65
Positioning Failure 63 63
Calcified 62 62
Product Quality Problem 61 61
Premature Activation 58 58
Delivered as Unsterile Product 56 56
Improper or Incorrect Procedure or Method 54 54
Material Too Rigid or Stiff 54 54
Difficult or Delayed Positioning 53 53
Material Discolored 48 48
Operating System Becomes Nonfunctional 48 48
Detachment of Device or Device Component 46 46
Unintended Ejection 46 46
Ejection Problem 46 46
Unstable 45 45
Torn Material 41 41
Activation, Positioning or Separation Problem 39 39
Manufacturing, Packaging or Shipping Problem 38 38
Device Markings/Labelling Problem 37 37
Fracture 37 37
Unexpected Therapeutic Results 35 35
Sharp Edges 35 35
Device Appears to Trigger Rejection 30 30
Sticking 27 27
Device Damaged Prior to Use 26 26
Material Rupture 25 25
Entrapment of Device 25 25
Optical Distortion 23 23
Split 22 22
Structural Problem 20 20
Deformation Due to Compressive Stress 20 20
Therapeutic or Diagnostic Output Failure 20 43
Detachment Of Device Component 20 20
Failure to Align 19 19
Bent 18 18
Failure to Deliver 15 15
Material Separation 14 14
Incorrect, Inadequate or Imprecise Result or Readings 14 14
Migration or Expulsion of Device 13 13
Component Missing 12 12
Packaging Problem 12 12
Inaccurate Information 12 12
Dent in Material 11 11
Contamination of Device Ingredient or Reagent 10 10
Patient Device Interaction Problem 10 10
Activation Problem 9 9
Material Frayed 9 9
Particulates 9 9
Misfocusing 8 8
Optical Decentration 8 8
Application Program Problem: Dose Calculation Error 7 7
Output Problem 7 7
Device Fell 7 7
Protective Measures Problem 6 6
Hole In Material 6 6
Device Slipped 6 6
Loose or Intermittent Connection 5 5

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 4115 4145
No Code Available 2099 2099
No Known Impact Or Consequence To Patient 1804 1989
No Consequences Or Impact To Patient 1251 2823
Visual Impairment 1201 1201
Insufficient Information 1142 1175
Blurred Vision 867 868
Capsular Bag Tear 830 830
Visual Disturbances 741 741
No Patient Involvement 591 591
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 573 621
Vitrectomy 428 428
Halo 263 263
Eye Injury 261 261
Failure of Implant 236 236
Inflammation 211 211
Corneal Edema 197 197
Endophthalmitis 140 140
No Information 107 107
Intraocular Pressure Increased 98 146
Discomfort 91 91
Toxic Anterior Segment Syndrome (TASS) 69 69
Therapeutic Effects, Unexpected 66 66
Pain 66 66
Dry Eye(s) 60 60
Eye Pain 59 59
Uveitis 57 105
Macular Edema 50 98
Zonular Dehiscence 48 48
Loss of Vision 45 45
Vitreous Loss 44 44
Red Eye(s) 43 43
Vitreous Floaters 39 39
Rupture 39 39
Hemorrhage/Bleeding 37 37
Flashers 37 37
Retinal Detachment 34 82
Unspecified Infection 33 33
Foreign Body In Patient 33 33
Iritis 28 28
Foreign Body Sensation in Eye 28 28
Glaucoma 26 26
Corneal Clouding/Hazing 24 24
Hyphema 24 24
Hypopyon 20 20
Edema 20 20
Fibrosis 20 20
Headache 18 18
Vitreous Hemorrhage 17 17
Irritation 14 14
Nausea 14 14
Intraocular Infection 13 13
Deposits 13 13
Capsular Contracture 13 13
Complaint, Ill-Defined 13 13
Patient Problem/Medical Problem 13 13
Tissue Damage 12 12
Swelling 12 13
Hyperemia 11 11
Calcium Deposits/Calcification 11 11
Excessive Tear Production 11 11
Swelling/ Edema 11 11
Dizziness 10 10
Vitreous Detachment 9 9
Prolapse 9 9
Unspecified Eye / Vision Problem 9 9
Therapeutic Response, Decreased 8 8
Erythema 8 8
Bacterial Infection 8 8
Eye Infections 8 8
Conjunctivitis 7 7
Retinal Tear 7 7
Reaction 7 7
Burning Sensation 7 7
Intraocular Pressure Decreased 7 7
UGH (Uveitis Glaucoma Hyphema) Syndrome 6 6
UGH (Uveitis-Glaucoma-Hyphema) Syndrome 6 6
Increased Sensitivity 6 6
Keratitis 6 6
High Blood Pressure/ Hypertension 6 6
Corneal Abrasion 6 6
Corneal Decompensation 6 6
Adhesion(s) 6 54
Wound Dehiscence 5 5
Cataract 5 5
Hypersensitivity/Allergic reaction 5 5
Scarring 5 5
Injury 5 5
Impaired Healing 5 5
Inadequate Pain Relief 4 4
Disability 4 4
Discharge 4 4
Itching Sensation 4 4
Corneal Stromal Edema 4 4
Fever 4 4
Retinal Injury 3 3
Vitritis 3 3
Collapse 3 3
Anxiety 3 3
Blood Loss 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 Bausch & Lomb Surgical, Inc. II Dec-18-2018
5 Johnson & Johnson Surgical Vision Inc II Nov-14-2018
6 Rayner Intraocular Lenses Limited II Sep-28-2018
7 Rayner Intraocular Lenses Ltd II Jul-06-2022
8 Tekia, Inc. II Dec-17-2019
-
-