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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device lens, contact, orthokeratology, overnight
Definition Temporary reduction of myopia or refractive error.
Product CodeNUU
Regulation Number 886.5916
Device Class 3

Premarket Approvals (PMA)
2019 2020 2021 2022 2023 2024
7 7 5 2 1 0

MDR Year MDR Reports MDR Events
2019 6 6
2020 1 1
2021 2 2
2022 1 1
2023 4 4
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 5 5
Break 3 3
Improper or Incorrect Procedure or Method 2 2
Migration 2 2
Defective Device 1 1
Patient-Device Incompatibility 1 1
Contamination /Decontamination Problem 1 1
Use of Device Problem 1 1
Patient Device Interaction Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Corneal Ulcer 4 4
Corneal Scar 3 3
Pain 2 2
Keratitis 2 2
Eye Pain 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
No Clinical Signs, Symptoms or Conditions 1 1
Acanthameba Keratitis 1 1
Visual Impairment 1 1
Corneal Infiltrates 1 1
No Known Impact Or Consequence To Patient 1 1
Eye Infections 1 1
Abrasion 1 1
Unspecified Infection 1 1
Irritation 1 1

Recalls
Manufacturer Recall Class Date Posted
1 PARAGON VISION SCIENCES, Inc II Sep-05-2023
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