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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)
2021 2022 2023 2024 2025 2026
5 2 1 3 3 5

MDR Year MDR Reports MDR Events
2021 2 2
2022 1 1
2023 4 4
2024 5 5
2025 12 12
2026 8 8

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 23 23
Use of Device Problem 3 3
Patient-Device Incompatibility 1 1
Defective Device 1 1
Insufficient Device Problem Information 1 1
Inadequacy of Device Shape and/or Size 1 1
Installation-Related Problem 1 1
Improper or Incorrect Procedure or Method 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Corneal Ulcer 11 11
Corneal Scar 11 11
Eye Pain 10 10
Keratitis 9 9
Red Eye(s) 6 6
Eye Infections 6 6
Corneal Infiltrates 5 5
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 5 5
Photophobia 4 4
Itching Sensation 4 4
Eye Irritation 4 4
Corneal Edema 4 4
Swelling/ Edema 4 4
Excessive Tear Production 4 4
Blurred Vision 3 3
Conjunctivitis 2 2
Infective Keratitis 2 2
Foreign Body Sensation in Eye 1 1
No Clinical Signs, Symptoms or Conditions 1 1
Corneal Abrasion 1 1
Pain 1 1
Eye Injury 1 1

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