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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)
2018 2019 2020 2021 2022 2023 2024
0 0 3 1 6 3 0

MDR Year MDR Reports MDR Events
2018 799 799
2019 735 819
2020 347 358
2021 598 599
2022 635 635
2023 552 552
2024 148 148

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 2675 2675
Scratched Material 190 190
Device Dislodged or Dislocated 114 114
Appropriate Term/Code Not Available 102 102
Break 101 197
Unintended Movement 95 95
Inadequacy of Device Shape and/or Size 86 86
Defective Device 80 80
Crack 57 57
Device Contamination with Chemical or Other Material 49 49
Malposition of Device 36 36
Unstable 30 30
Material Opacification 25 25
Mechanical Problem 20 20
Material Split, Cut or Torn 20 20
Insufficient Information 18 18
Contamination 14 14
Defective Component 14 14
Device Damaged by Another Device 13 13
Migration or Expulsion of Device 13 13
Use of Device Problem 12 12
Contamination /Decontamination Problem 11 11
Failure to Advance 11 11
Application Program Problem: Power Calculation Error 11 11
Failure to Eject 10 10
Optical Decentration 9 9
Product Quality Problem 9 9
Patient-Device Incompatibility 9 9
Inaccurate Delivery 8 8
Failure to Unfold or Unwrap 8 8
Material Fragmentation 8 8
Incorrect, Inadequate or Imprecise Result or Readings 7 7
Unexpected Therapeutic Results 5 5
Difficult to Insert 5 5
Application Program Problem: Dose Calculation Error 5 5
Difficult to Fold, Unfold or Collapse 5 5
Structural Problem 5 5
Invalid Sensing 5 5
Failure to Align 4 4
Dent in Material 4 4
Device Markings/Labelling Problem 4 4
Positioning Problem 4 4
Material Discolored 4 4
Torn Material 4 4
Patient Device Interaction Problem 3 3
Physical Resistance/Sticking 3 3
Failure to Fold 3 3
Labelling, Instructions for Use or Training Problem 3 3
Nonstandard Device 3 3
Delivered as Unsterile Product 3 3
No Apparent Adverse Event 3 3
Material Twisted/Bent 3 3
Material Deformation 2 2
Device Contaminated During Manufacture or Shipping 2 2
Expulsion 2 2
Detachment of Device or Device Component 2 2
Difficult to Advance 2 2
Positioning Failure 2 2
Particulates 2 2
Device Difficult to Setup or Prepare 2 2
Off-Label Use 1 1
Premature Activation 1 1
Unsealed Device Packaging 1 1
Kinked 1 1
Fracture 1 1
Difficult or Delayed Positioning 1 1
Arcing 1 1
Device Damaged Prior to Use 1 1
Component Missing 1 1
Failure to Deliver 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Material Integrity Problem 1 1
Mechanical Jam 1 1
Therapeutic or Diagnostic Output Failure 1 1
Packaging Problem 1 1
Inaccurate Information 1 1
Air/Gas in Device 1 1
Ejection Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Code Available 1552 1552
Blurred Vision 1060 1060
Visual Disturbances 919 919
Visual Impairment 763 763
Halo 707 707
No Clinical Signs, Symptoms or Conditions 291 291
Insufficient Information 250 250
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 195 195
Dry Eye(s) 103 103
Corneal Edema 57 57
Discomfort 55 55
Flashers 54 54
Capsular Bag Tear 53 53
Vitrectomy 52 52
Headache 51 51
Inflammation 50 50
No Consequences Or Impact To Patient 48 144
Eye Injury 39 39
Eye Pain 38 38
Therapeutic Effects, Unexpected 36 36
Vitreous Floaters 28 28
No Known Impact Or Consequence To Patient 27 27
No Patient Involvement 24 24
Macular Edema 23 23
Pain 20 20
Intraocular Pressure Increased 19 19
Foreign Body Sensation in Eye 16 16
Dizziness 16 16
Endophthalmitis 15 15
Nausea 15 15
Uveitis 12 12
Excessive Tear Production 10 10
Unspecified Eye / Vision Problem 10 10
Irritation 9 9
Unspecified Infection 9 9
Red Eye(s) 8 8
Zonular Dehiscence 8 8
Itching Sensation 7 7
Iritis 7 7
Glaucoma 7 7
Conjunctivitis 7 7
Irritability 6 6
Swelling/ Edema 6 6
Retinal Detachment 5 5
Failure of Implant 4 4
Hypersensitivity/Allergic reaction 3 3
Fatigue 3 3
Corneal Abrasion 3 3
Corneal Clouding/Hazing 3 3
Anxiety 3 3
Fibrosis 3 3
Keratitis 3 3
Swelling 3 3
Loss of Vision 3 3
Unspecified Tissue Injury 3 3
Intraocular Pressure Decreased 3 3
Toxic Anterior Segment Syndrome (TASS) 3 3
Ptosis 2 2
Balance Problems 2 2
Rupture 2 2
Vitreous Loss 2 2
Hemorrhage/Bleeding 2 2
Hyphema 2 2
Hypopyon 2 2
Retinal Tear 2 2
Scar Tissue 2 2
Sunset Syndrome 1 1
Intraocular Infection 1 1
Edema 1 1
Bacterial Infection 1 1
Capsular Contracture 1 1
Chemosis 1 1
Corneal Scar 1 1
Corneal Ulcer 1 1
Cyst(s) 1 1
Vitreous Hemorrhage 1 1
Twitching 1 1
Clouding, Central Corneal 1 1
Vertigo 1 1
No Information 1 1
Foreign Body In Patient 1 1
Distress 1 1
Vitreous Detachment 1 1
Depression 1 1
Impaired Healing 1 1
Fungal Infection 1 1
Eye Infections 1 1
UGH (Uveitis Glaucoma Hyphema) Syndrome 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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