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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device lens, spectacle, non-custom (prescription)
Product CodeHQG
Regulation Number 886.5844
Device Class 1

MDR Year MDR Reports MDR Events
2015 4 4
2017 1 1
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
Material Distortion 2 2
Break 2 2
Appropriate Term/Code Not Available 2 2
Crack 1 1
Optical Distortion 1 1
Protective Measures Problem 1 1
Scratched Material 1 1
Defective Device 1 1
Device Operates Differently Than Expected 1 1
Compatibility Problem 1 1
Manufacturing, Packaging or Shipping Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 5 5
Insufficient Information 2 2
Visual Impairment 2 2
Dizziness 2 2
Headache 1 1
Hypersensitivity/Allergic reaction 1 1
Itching Sensation 1 1
Rash 1 1
Blurred Vision 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Eyemart Express Ltd II Dec-16-2014
2 Frames Direct II May-20-2020
3 Luxottica Optical Manufacturing II Mar-07-2011
4 Wal Mart Stores, Inc II Jun-17-2014
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