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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
Regulation Description Rigid gas permeable contact lens.
Definition Temporary reduction of myopia or refractive error.
Product CodeNUU
Regulation Number 886.5916
Device Class 3

Premarket Approvals (PMA)
2020 2021 2022 2023 2024 2025 2026
7 5 2 1 3 3 0

MDR Year MDR Reports MDR Events
2020 1 1
2021 2 2
2022 1 1
2023 4 4
2024 5 5
2025 12 12

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 16 16
Use of Device Problem 3 3
Improper or Incorrect Procedure or Method 2 2
Insufficient Information 1 1
Patient-Device Incompatibility 1 1
Defective Device 1 1
Patient Device Interaction Problem 1 1
Contamination /Decontamination Problem 1 1
Lack of Effect 1 1
Installation-Related Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Corneal Scar 11 11
Corneal Ulcer 10 10
Eye Pain 8 8
Red Eye(s) 6 6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 5 5
Keratitis 5 5
Corneal Infiltrates 5 5
Itching Sensation 4 4
Eye Infections 4 4
Corneal Edema 4 4
Excessive Tear Production 4 4
Blurred Vision 3 3
Conjunctivitis 2 2
Swelling/ Edema 2 2
Unspecified Infection 1 1
No Clinical Signs, Symptoms or Conditions 1 1
Acanthameba Keratitis 1 1
Pain 1 1

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