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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 32 32

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 2007 2007
Scratched Material 168 168
Device Dislodged or Dislocated 100 100
Break 88 184
Appropriate Term/Code Not Available 84 84
Defective Device 72 72
Unintended Movement 69 69
Crack 49 49
Device Contamination with Chemical or Other Material 38 38
Malposition of Device 36 36
Unstable 29 29
Material Opacification 23 23
Insufficient Information 17 17
Material Split, Cut or Torn 16 16
Mechanical Problem 16 16
Defective Component 14 14
Contamination 13 13
Use of Device Problem 12 12
Application Program Problem: Power Calculation Error 11 11
Device Damaged by Another Device 11 11
Failure to Advance 9 9
Optical Decentration 9 9
Inaccurate Delivery 8 8
Product Quality Problem 8 8
Material Fragmentation 7 7
Patient-Device Incompatibility 7 7
Contamination /Decontamination Problem 6 6
Failure to Eject 6 6
Incorrect, Inadequate or Imprecise Result or Readings 6 6
Failure to Unfold or Unwrap 6 6
Inadequacy of Device Shape and/or Size 5 5
Unexpected Therapeutic Results 5 5
Structural Problem 5 5
Application Program Problem: Dose Calculation Error 5 5
Difficult to Fold, Unfold or Collapse 5 5
Failure to Align 4 4
Device Markings/Labelling Problem 4 4
Material Twisted/Bent 3 3
Positioning Problem 3 3
No Apparent Adverse Event 3 3
Difficult to Insert 3 3
Labelling, Instructions for Use or Training Problem 3 3
Material Discolored 3 3
Nonstandard Device 3 3
Delivered as Unsterile Product 3 3
Failure to Fold 2 2
Positioning Failure 2 2
Dent in Material 2 2
Patient Device Interaction Problem 2 2
Physical Resistance/Sticking 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
Manufacturing, Packaging or Shipping Problem 1 1
Material Integrity Problem 1 1
Mechanical Jam 1 1
Packaging Problem 1 1
Air/Gas in Device 1 1
Ejection Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Device Damaged Prior to Use 1 1
Failure to Deliver 1 1
Device Difficult to Setup or Prepare 1 1
Fracture 1 1
Unsealed Device Packaging 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Blurred Vision 897 897
No Code Available 881 881
Visual Disturbances 734 734
Visual Impairment 638 638
Halo 505 505
No Clinical Signs, Symptoms or Conditions 276 276
Insufficient Information 224 224
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 189 189
Dry Eye(s) 85 85
Flashers 53 53
Corneal Edema 48 48
Discomfort 45 45
Capsular Bag Tear 44 44
Headache 44 44
Inflammation 39 39
Eye Pain 37 37
Therapeutic Effects, Unexpected 36 36
Eye Injury 35 35
No Consequences Or Impact To Patient 31 127
Vitrectomy 31 31
Vitreous Floaters 25 25
Macular Edema 20 20
Intraocular Pressure Increased 18 18
Nausea 15 15
Pain 15 15
Foreign Body Sensation in Eye 14 14
Dizziness 14 14
No Known Impact Or Consequence To Patient 13 13
No Patient Involvement 11 11
Excessive Tear Production 10 10
Endophthalmitis 9 9
Uveitis 8 8
Unspecified Eye / Vision Problem 8 8
Zonular Dehiscence 7 7
Conjunctivitis 7 7
Red Eye(s) 6 6
Irritation 6 6
Itching Sensation 6 6
Irritability 6 6
Swelling/ Edema 6 6
Iritis 5 5
Unspecified Infection 5 5
Glaucoma 5 5
Failure of Implant 4 4
Corneal Clouding/Hazing 3 3
Corneal Abrasion 3 3
Fibrosis 3 3
Intraocular Pressure Decreased 3 3
Toxic Anterior Segment Syndrome (TASS) 3 3
Swelling 3 3
Unspecified Tissue Injury 3 3
Ptosis 2 2
Rupture 2 2
Vitreous Loss 2 2
Balance Problems 2 2
Fatigue 2 2
Hemorrhage/Bleeding 2 2
Hypersensitivity/Allergic reaction 2 2
Hyphema 2 2
Hypopyon 2 2
Keratitis 2 2
Retinal Detachment 2 2
Retinal Tear 2 2
Scar Tissue 2 2
Sunset Syndrome 1 1
Intraocular Infection 1 1
Bacterial Infection 1 1
Capsular Contracture 1 1
Chemosis 1 1
Corneal Scar 1 1
Corneal Ulcer 1 1
Edema 1 1
Eye Infections 1 1
UGH (Uveitis Glaucoma Hyphema) Syndrome 1 1
Vitreous Detachment 1 1
Depression 1 1
Impaired Healing 1 1
Foreign Body In Patient 1 1
Vitreous Hemorrhage 1 1
Twitching 1 1
Vertigo 1 1
Loss of Vision 1 1
Anxiety 1 1
Distress 1 1
Clouding, Central Corneal 1 1
Decreased Appetite 1 1
Dry Mouth 1 1

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