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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)
2020 2021 2022 2023 2024 2025
0 0 2 0 0 0

MDR Year MDR Reports MDR Events
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 23 23
Adverse Event Without Identified Device or Use Problem 15 15
Material Twisted/Bent 9 9
Break 5 5
Material Split, Cut or Torn 4 4
Insufficient Information 3 3
Mechanical Problem 2 2
Unintended Movement 1 1
Defective Device 1 1
Therapeutic or Diagnostic Output Failure 1 1
Patient Device Interaction Problem 1 1
Use of Device Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Code Available 23 23
Visual Impairment 19 19
Blurred Vision 13 13
Halo 6 6
Visual Disturbances 5 5
Capsular Bag Tear 4 4
Vitreous Detachment 3 3
No Information 3 3
Dry Eye(s) 3 3
Insufficient Information 3 3
Vitrectomy 3 3
Vitreous Loss 2 2
No Clinical Signs, Symptoms or Conditions 2 2
Glaucoma 2 2
Capsular Contracture 2 2
Headache 2 2
Eye Pain 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Failure of Implant 1 1
Unspecified Eye / Vision Problem 1 1
Vitreous Floaters 1 1
Hemorrhage/Bleeding 1 1
Loss of Vision 1 1
Fibrosis 1 1

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