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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device implant, corneal, refractive
Product CodeLQE
Device Class 3

Premarket Approvals (PMA)
2020 2021 2022 2023 2024 2025
0 0 1 0 1 1

MDR Year MDR Reports MDR Events
2020 2 2
2021 3 4
2022 2 2
2023 3 3
2024 2 2
2025 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Patient-Device Incompatibility 3 4
Adverse Event Without Identified Device or Use Problem 3 3
Therapeutic or Diagnostic Output Failure 1 1
Patient Device Interaction Problem 1 1
Nonstandard Device 1 1
Unexpected Therapeutic Results 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Blurred Vision 8 8
Failure of Implant 6 6
Visual Impairment 6 6
Corneal Clouding/Hazing 3 4
Dry Eye(s) 2 2
Unspecified Eye / Vision Problem 2 2
Headache 2 2
Corneal Scar 2 2
Unspecified Infection 1 1
Nausea 1 1
Corneal Abrasion 1 1
Visual Disturbances 1 1
Pain 1 1
Scar Tissue 1 1
Eye Injury 1 2
Eye Infections 1 2
Eye Pain 1 1
Increased Sensitivity 1 1

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