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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
Product CodeMWL
Regulation Number 886.5916
Device Class 3

Premarket Approvals (PMA)
2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024
2 0 1 0 0 2 4 1 4 1 0

MDR Year MDR Reports MDR Events
2018 1 1
2019 2 2
2020 1 1
2021 1 1
2022 1 1
2023 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 4 4
Appropriate Term/Code Not Available 1 1
Device Markings/Labelling Problem 1 1
Device Contamination with Chemical or Other Material 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 3 3
Corneal Ulcer 2 2
Corneal Clouding/Hazing 1 1
Corneal Abrasion 1 1
Corneal Scar 1 1
Scarring 1 1
Blurred Vision 1 1
Loss of Vision 1 1
Excessive Tear Production 1 1
Ulcer 1 1
Caustic/Chemical Burns 1 1
No Known Impact Or Consequence To Patient 1 1
Insufficient Information 1 1

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