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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device extended depth of focus intraocular lens
Definition Intended to be implanted to replace the natural lens of an eye.
Product CodePOE
Regulation Number 886.3600
Device Class 3

Premarket Approvals (PMA)
2019 2020 2021 2022 2023 2024
0 3 1 6 3 0

MDR Year MDR Reports MDR Events
2019 735 819
2020 347 358
2021 598 599
2022 635 635
2023 552 552
2024 296 304

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 2173 2181
Scratched Material 198 198
Device Dislodged or Dislocated 107 107
Break 98 194
Appropriate Term/Code Not Available 88 88
Defective Device 85 85
Unintended Movement 69 69
Crack 54 54
Device Contamination with Chemical or Other Material 38 38
Malposition of Device 36 36
Unstable 30 30
Material Opacification 25 25
Insufficient Information 19 19
Material Split, Cut or Torn 18 18
Mechanical Problem 16 16
Defective Component 16 16
Failure to Eject 14 14
Device Damaged by Another Device 13 13
Failure to Advance 13 13
Contamination 13 13
Use of Device Problem 12 12
Application Program Problem: Power Calculation Error 12 12
Optical Decentration 11 11
Material Fragmentation 8 8
Product Quality Problem 8 8
Inaccurate Delivery 8 8
Incorrect, Inadequate or Imprecise Result or Readings 7 7
Failure to Unfold or Unwrap 7 7
Patient-Device Incompatibility 7 7
Contamination /Decontamination Problem 6 6
Device Markings/Labelling Problem 6 6
Application Program Problem: Dose Calculation Error 6 6
Difficult to Fold, Unfold or Collapse 6 6
Inadequacy of Device Shape and/or Size 5 5
Unexpected Therapeutic Results 5 5
Structural Problem 5 5
Failure to Align 4 4
Material Discolored 4 4
Difficult to Insert 3 3
Labelling, Instructions for Use or Training Problem 3 3
Nonstandard Device 3 3
Delivered as Unsterile Product 3 3
Dent in Material 3 3
Device Difficult to Setup or Prepare 3 3
Material Deformation 3 3
Material Twisted/Bent 3 3
Positioning Problem 3 3
No Apparent Adverse Event 3 3
Physical Resistance/Sticking 2 2
Ejection Problem 2 2
Patient Device Interaction Problem 2 2
Mechanical Jam 2 2
Device Contaminated During Manufacture or Shipping 2 2
Particulates 2 2
Difficult to Advance 2 2
Detachment of Device or Device Component 2 2
Device Damaged Prior to Use 2 2
Failure to Fold 2 2
Positioning Failure 2 2
Fracture 1 1
Unsealed Device Packaging 1 1
Failure to Deliver 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Material Integrity Problem 1 1
Air/Gas in Device 1 1
Therapeutic or Diagnostic Output Failure 1 1
Packaging Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Blurred Vision 984 985
No Code Available 881 881
Visual Disturbances 789 794
Visual Impairment 693 693
Halo 527 528
No Clinical Signs, Symptoms or Conditions 312 312
Insufficient Information 285 285
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 198 198
Dry Eye(s) 93 93
Flashers 56 58
Discomfort 53 53
Corneal Edema 51 51
Headache 49 49
Capsular Bag Tear 46 46
Eye Injury 42 42
Inflammation 42 42
Eye Pain 40 40
Therapeutic Effects, Unexpected 36 36
No Consequences Or Impact To Patient 31 127
Vitrectomy 31 31
Vitreous Floaters 29 29
Macular Edema 21 21
Intraocular Pressure Increased 19 19
Dizziness 16 16
Nausea 15 15
Pain 15 15
Foreign Body Sensation in Eye 15 15
Unspecified Eye / Vision Problem 15 15
No Known Impact Or Consequence To Patient 13 13
No Patient Involvement 11 11
Excessive Tear Production 10 10
Endophthalmitis 10 10
Uveitis 8 8
Zonular Dehiscence 7 7
Conjunctivitis 7 7
Red Eye(s) 7 7
Irritability 6 6
Irritation 6 6
Itching Sensation 6 6
Toxic Anterior Segment Syndrome (TASS) 6 6
Swelling/ Edema 6 6
Iritis 5 5
Unspecified Infection 5 5
Glaucoma 5 5
Failure of Implant 4 4
Hypersensitivity/Allergic reaction 3 3
Corneal Clouding/Hazing 3 3
Corneal Abrasion 3 3
Swelling 3 3
Fibrosis 3 3
Balance Problems 3 3
Intraocular Pressure Decreased 3 3
Unspecified Tissue Injury 3 3
Distress 2 3
Ptosis 2 2
Rupture 2 2
Keratitis 2 2
Vitreous Loss 2 2
Corneal Scar 2 2
Capsular Contracture 2 2
Hyphema 2 2
Hypopyon 2 2
Fatigue 2 2
Hemorrhage/Bleeding 2 2
Retinal Detachment 2 2
Retinal Tear 2 2
Scar Tissue 2 2
Sunset Syndrome 1 1
Intraocular Infection 1 1
Chemosis 1 1
Adhesion(s) 1 1
Bacterial Infection 1 1
Corneal Ulcer 1 1
Edema 1 1
Vitreous Hemorrhage 1 1
Twitching 1 1
Vertigo 1 1
Clouding, Central Corneal 1 1
Loss of Vision 1 1
Vitreous Detachment 1 1
Anxiety 1 1
Depression 1 1
Impaired Healing 1 1
Eye Infections 1 1
Foreign Body In Patient 1 1
Decreased Appetite 1 1
Dry Mouth 1 1
UGH (Uveitis Glaucoma Hyphema) Syndrome 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Johnson & Johnson Surgical Vision, Inc. II Aug-03-2023
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