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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search show TPLC since Back to Search Results
Device lens, spectacle, non-custom (prescription)
Product CodeHQG
Regulation Number 886.5844
Device Class 1

MDR Year MDR Reports MDR Events
2018 3 3
2019 1 1
2020 2 2
2022 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Product Quality Problem 2 2
Compatibility Problem 1 1
Material Distortion 1 1
Optical Distortion 1 1
Scratched Material 1 1
Break 1 1
Crack 1 1
Defective Device 1 1
Appropriate Term/Code Not Available 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 3 3
Insufficient Information 2 2
Rash 1 1
Itching Sensation 1 1
Dizziness 1 1
Hypersensitivity/Allergic reaction 1 1
Blurred Vision 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Frames Direct II May-20-2020
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