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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device lens, contact (rigid gas permeable), extended wear
Regulation Description Rigid gas permeable contact lens.
Product CodeMWL
Regulation Number 886.5916
Device Class 3

Premarket Approvals (PMA)
2020 2021 2022 2023 2024 2025 2026
4 1 4 1 1 1 0

MDR Year MDR Reports MDR Events
2020 1 1
2021 1 1
2022 1 1
2023 1 1
2025 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 1 1
Appropriate Device Problem Term/Code Not Available 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Blurred Vision 2 2
Corneal Abrasion 1 1
Corneal Ulcer 1 1
No Known Impact Or Consequence To Patient 1 1
Insufficient Information 1 1
Pain 1 1
Infective Keratitis 1 1
Caustic/Chemical Burns 1 1
Excessive Tear Production 1 1

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