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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device lens, intraocular, accommodative
Product CodeNAA
Regulation Number 886.3600
Device Class 3

Premarket Approvals (PMA)
2018 2019 2020 2021 2022 2023 2024
0 0 0 0 2 0 0

MDR Year MDR Reports MDR Events
2018 49 49
2019 34 34
2020 23 23
2021 18 18
2022 8 8
2023 2 2
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Device Dislodged or Dislocated 74 74
Adverse Event Without Identified Device or Use Problem 31 31
Material Twisted/Bent 11 11
Break 11 11
Material Split, Cut or Torn 5 5
Insufficient Information 4 4
Use of Device Problem 3 3
Mechanical Problem 3 3
Therapeutic or Diagnostic Output Failure 3 3
Unintended Movement 2 2
Patient Device Interaction Problem 1 1
Positioning Failure 1 1
Difficult To Position 1 1
Optical Discoloration 1 1
Material Opacification 1 1
Difficult to Advance 1 1
Defective Device 1 1
Mechanics Altered 1 1
Pitted 1 1
Device Handling Problem 1 1
Mechanical Jam 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Visual Impairment 61 61
No Code Available 30 30
No Known Impact Or Consequence To Patient 23 23
Blurred Vision 16 16
Eye Injury 13 13
Visual Disturbances 10 10
Halo 9 9
Capsular Bag Tear 8 8
Vitrectomy 8 8
Fibrosis 5 5
Capsular Contracture 4 4
Vitreous Loss 3 3
Vitreous Detachment 3 3
Macular Edema 3 3
No Information 3 3
Dry Eye(s) 3 3
Glaucoma 3 3
Insufficient Information 3 3
No Clinical Signs, Symptoms or Conditions 2 2
Pain 2 2
Headache 2 2
Loss of Vision 2 2
Eye Pain 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Failure of Implant 1 1
Edema 1 1
Keratitis 1 1
Zonular Dehiscence 1 1
Retinal Detachment 1 1
Unspecified Eye / Vision Problem 1 1
Vitreous Floaters 1 1
Hemorrhage/Bleeding 1 1

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