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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 148 148

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 2084 2084
Scratched Material 178 178
Device Dislodged or Dislocated 102 102
Break 92 188
Appropriate Term/Code Not Available 87 87
Defective Device 79 79
Unintended Movement 69 69
Crack 50 50
Device Contamination with Chemical or Other Material 38 38
Malposition of Device 36 36
Unstable 30 30
Material Opacification 23 23
Insufficient Information 18 18
Material Split, Cut or Torn 17 17
Mechanical Problem 16 16
Defective Component 14 14
Contamination 13 13
Device Damaged by Another Device 13 13
Use of Device Problem 12 12
Failure to Advance 11 11
Application Program Problem: Power Calculation Error 11 11
Failure to Eject 10 10
Optical Decentration 9 9
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
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
Material Discolored 4 4
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
Nonstandard Device 3 3
Delivered as Unsterile Product 3 3
Failure to Fold 2 2
Positioning Failure 2 2
Dent in Material 2 2
Device Difficult to Setup or Prepare 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 Deformation 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
Fracture 1 1
Unsealed Device Packaging 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Blurred Vision 937 937
No Code Available 881 881
Visual Disturbances 763 763
Visual Impairment 654 654
Halo 518 518
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) 90 90
Flashers 53 53
Corneal Edema 51 51
Discomfort 50 50
Headache 47 47
Capsular Bag Tear 45 45
Inflammation 39 39
Eye Injury 39 39
Eye Pain 38 38
Therapeutic Effects, Unexpected 36 36
No Consequences Or Impact To Patient 31 127
Vitrectomy 31 31
Vitreous Floaters 25 25
Macular Edema 21 21
Intraocular Pressure Increased 19 19
Nausea 15 15
Pain 15 15
Dizziness 15 15
Foreign Body Sensation in Eye 14 14
No Known Impact Or Consequence To Patient 13 13
No Patient Involvement 11 11
Excessive Tear Production 10 10
Unspecified Eye / Vision Problem 10 10
Endophthalmitis 9 9
Uveitis 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
Hypersensitivity/Allergic reaction 3 3
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
Hyphema 2 2
Hypopyon 2 2
Hemorrhage/Bleeding 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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