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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
Regulation Description Intraocular lens.
Product CodeNAA
Regulation Number 886.3600
Device Class 3

Premarket Approvals (PMA)
2021 2022 2023 2024 2025 2026
0 2 0 0 0 0

MDR Year MDR Reports MDR Events
2021 18 18
2022 8 9
2023 2 2
2024 1 1
2026 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 12 12
Device Dislodged or Dislocated 9 9
Material Split, Cut or Torn 2 2
Defective Device 2 2
Material Twisted/Bent 2 2
Break 1 1
Mechanical Problem 1 1
Unintended Movement 1 1
Insufficient Information 1 1
Therapeutic or Diagnostic Output Failure 1 2
Patient Device Interaction Problem 1 1
Material Deformation 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Blurred Vision 10 10
Visual Impairment 9 9
Halo 3 4
Capsular Bag Tear 3 3
Visual Disturbances 3 3
Insufficient Information 3 3
No Clinical Signs, Symptoms or Conditions 2 2
Capsular Contracture 2 2
Headache 2 2
Eye Pain 2 2
Vitreous Loss 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Vitreous Detachment 1 2
No Code Available 1 1
Failure of Implant 1 1
No Information 1 1
Dry Eye(s) 1 1
Unspecified Eye / Vision Problem 1 1
Scar Tissue 1 1
Vitreous Floaters 1 1
Loss of Vision 1 1
Fibrosis 1 1

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