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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)
2021 2022 2023 2024 2025 2026
1 4 1 1 1 0

MDR Year MDR Reports MDR Events
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 2 2
Device Contamination with Chemical or Other Material 1 1
Appropriate 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
Acanthameba Keratitis 1 1
Corneal Ulcer 1 1
Insufficient Information 1 1
Pain 1 1
Caustic/Chemical Burns 1 1
Excessive Tear Production 1 1

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