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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 6

MDR Year MDR Reports MDR Events
2019 3086 3603
2020 1981 3096
2021 2925 3096
2022 3290 3290
2023 3909 3957
2024 951 951

Device Problems MDRs with this Device Problem Events in those MDRs
Break 3414 4850
Adverse Event Without Identified Device or Use Problem 3287 3335
Scratched Material 1392 1456
Material Split, Cut or Torn 852 852
Crack 839 981
Defective Device 680 680
Failure to Eject 557 557
Contamination 467 467
Material Opacification 397 397
Material Fragmentation 394 394
Appropriate Term/Code Not Available 383 383
Device Dislodged or Dislocated 361 361
Inaccurate Delivery 349 349
Use of Device Problem 328 328
Failure to Advance 312 312
Device Contamination with Chemical or Other Material 242 242
Difficult to Fold, Unfold or Collapse 224 224
Mechanical Jam 205 205
Off-Label Use 196 196
Physical Resistance/Sticking 190 190
Failure to Unfold or Unwrap 187 187
Defective Component 184 299
Device Damaged by Another Device 181 227
Material Twisted/Bent 179 179
No Apparent Adverse Event 162 162
Ejection Problem 158 158
Unintended Movement 158 158
Failure to Fold 144 144
Contamination /Decontamination Problem 122 122
Device Difficult to Setup or Prepare 108 108
Mechanical Problem 100 100
Insufficient Information 97 97
Difficult to Advance 86 86
Device Contaminated During Manufacture or Shipping 84 84
Material Deformation 84 84
Malposition of Device 82 82
Material Integrity Problem 75 75
Unintended Ejection 74 74
Difficult to Insert 70 70
Sharp Edges 65 65
Delivered as Unsterile Product 64 64
Device Handling Problem 63 63
Operating System Becomes Nonfunctional 62 62
Product Quality Problem 60 60
Material Too Rigid or Stiff 57 57
Positioning Problem 57 57
Material Discolored 53 53
Calcified 50 50
Optical Problem 50 50
Improper or Incorrect Procedure or Method 49 49
Device Appears to Trigger Rejection 48 48
Premature Activation 46 46
Unstable 44 44
Separation Problem 44 44
Patient-Device Incompatibility 43 43
Fracture 41 41
Particulates 40 40
Manufacturing, Packaging or Shipping Problem 39 39
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
Entrapment of Device 22 22
Unexpected Therapeutic Results 21 21
Incorrect, Inadequate or Imprecise Result or Readings 21 21
Therapeutic or Diagnostic Output Failure 20 43
Structural Problem 19 19
Failure to Align 17 17
Material Rupture 16 16
Optical Decentration 15 15
Inadequacy of Device Shape and/or Size 14 14
Component Missing 14 14
Failure to Deliver 14 14
Application Program Problem: Dose Calculation Error 13 13
Misfocusing 12 12
Inaccurate Information 12 12
Activation Problem 11 11
Contamination of Device Ingredient or Reagent 10 10
Dent in Material 10 10
Positioning Failure 10 10
Patient Device Interaction Problem 9 9
Packaging Problem 8 8
Deformation Due to Compressive Stress 7 7
Misassembled 7 7
Labelling, Instructions for Use or Training Problem 6 6
Material Separation 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
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
Fitting Problem 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 5611 5641
Insufficient Information 1795 1828
No Known Impact Or Consequence To Patient 1402 1587
No Code Available 1375 1375
Visual Impairment 1253 1253
Blurred Vision 878 879
Capsular Bag Tear 811 811
No Consequences Or Impact To Patient 805 2377
Visual Disturbances 763 763
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 726 774
Failure of Implant 538 538
Eye Injury 309 309
No Patient Involvement 309 309
Vitrectomy 308 308
Halo 243 243
Inflammation 226 226
Corneal Edema 200 200
Endophthalmitis 155 155
Intraocular Pressure Increased 102 150
Toxic Anterior Segment Syndrome (TASS) 88 88
Discomfort 86 86
Eye Pain 81 81
Therapeutic Effects, Unexpected 63 63
Uveitis 61 109
Macular Edema 58 106
Dry Eye(s) 57 57
Zonular Dehiscence 54 54
Flashers 51 51
No Information 49 49
Vitreous Floaters 44 44
Red Eye(s) 44 44
Pain 42 42
Vitreous Loss 41 41
Retinal Detachment 38 86
Foreign Body In Patient 33 33
Glaucoma 31 31
Hemorrhage/Bleeding 29 29
Hyphema 29 29
Fibrosis 29 29
Rupture 29 29
Iritis 28 28
Corneal Clouding/Hazing 25 25
Loss of Vision 25 25
Vitreous Hemorrhage 23 23
Headache 23 23
Hypopyon 23 23
Foreign Body Sensation in Eye 22 22
Unspecified Eye / Vision Problem 21 21
Eye Infections 19 19
Swelling/ Edema 16 16
Unspecified Infection 16 16
Hyperemia 14 14
Capsular Contracture 13 13
Excessive Tear Production 13 13
Vitreous Detachment 12 12
Deposits 12 12
Irritation 12 12
Tissue Damage 12 12
Intraocular Infection 11 11
Conjunctivitis 10 10
Calcium Deposits/Calcification 10 10
Prolapse 10 10
Dizziness 10 10
Bacterial Infection 9 9
Hypersensitivity/Allergic reaction 9 9
Edema 9 9
Keratitis 8 8
Therapeutic Response, Decreased 8 8
UGH (Uveitis Glaucoma Hyphema) Syndrome 8 8
Intraocular Pressure Decreased 7 7
Nausea 7 7
Cataract 7 7
Corneal Decompensation 6 6
Retinal Tear 6 6
Ptosis 6 6
Patient Problem/Medical Problem 5 5
Complaint, Ill-Defined 5 5
Impaired Healing 5 5
Swelling 5 6
Wound Dehiscence 5 5
Adhesion(s) 5 53
Corneal Abrasion 4 4
Corneal Stromal Edema 4 4
Erythema 4 4
UGH (Uveitis-Glaucoma-Hyphema) Syndrome 4 4
High Blood Pressure/ Hypertension 4 4
Inadequate Pain Relief 4 4
Injury 4 4
Anxiety 4 4
Vitritis 4 4
Discharge 4 4
Burning Sensation 3 3
Fungal Infection 3 3
Irritability 3 3
Blood Loss 3 3
Increased Sensitivity 3 3
Itching Sensation 3 3
Scarring 3 3
Pupillary Block 3 3
Fever 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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