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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search show TPLC since Back to Search Results
Device lens, intraocular, accommodative
Product CodeNAA
Regulation Number 886.3600
Device Class 3

Premarket Approvals (PMA)
2017 2018 2019 2020 2021 2022
0 0 0 0 0 2

MDR Year MDR Reports MDR Events
2017 68 68
2018 49 49
2019 34 34
2020 23 23
2021 18 18
2022 7 7

Device Problems MDRs with this Device Problem Events in those MDRs
Device Dislodged or Dislocated 120 120
Adverse Event Without Identified Device or Use Problem 49 49
Break 12 12
Material Twisted/Bent 11 11
Insufficient Information 5 5
Material Split, Cut or Torn 5 5
Mechanical Problem 3 3
Use of Device Problem 3 3
Unintended Movement 3 3
Difficult To Position 2 2
Therapeutic or Diagnostic Output Failure 2 2
Torn Material 1 1
Defective Device 1 1
Difficult to Advance 1 1
Optical Discoloration 1 1
Material Opacification 1 1
Pitted 1 1
Positioning Failure 1 1
Mechanical Jam 1 1
Mechanics Altered 1 1
Device Handling Problem 1 1
Patient Device Interaction Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Visual Impairment 91 91
No Known Impact Or Consequence To Patient 37 37
No Code Available 31 31
Blurred Vision 26 26
Visual Disturbances 16 16
Capsular Bag Tear 14 14
Eye Injury 13 13
Vitrectomy 9 9
Fibrosis 8 8
Pain 7 7
Halo 7 7
No Information 4 4
Dry Eye(s) 4 4
Macular Edema 3 3
Glaucoma 3 3
Vitreous Loss 3 3
Loss of Vision 3 3
Insufficient Information 3 3
Eye Pain 2 2
No Clinical Signs, Symptoms or Conditions 2 2
Retinal Detachment 2 2
Discomfort 2 2
Vitreous Detachment 2 2
Zonular Dehiscence 2 2
Headache 2 2
Capsular Contracture 2 2
Corneal Edema 2 2
Edema 1 1
Endophthalmitis 1 1
Vitreous Floaters 1 1
Hemorrhage/Bleeding 1 1
Hypopyon 1 1
Failure of Implant 1 1
Inflammation 1 1
Irritation 1 1
Keratitis 1 1
Post Operative Wound Infection 1 1
Uveitis 1 1
Unspecified Eye / Vision Problem 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1

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