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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device sunglasses (non-prescription including photosensitive)
Product CodeHQY
Regulation Number 886.5850
Device Class 1

MDR Year MDR Reports MDR Events
2014 2 2
2015 4 4
2016 2 2
2017 1 1
2018 1 1
2019 2 2
2022 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Material Fragmentation 2 2
Break 2 2
Detachment Of Device Component 1 1
Material Disintegration 1 1
Flaked 1 1
Fogging 1 1
Loose or Intermittent Connection 1 1
Nonstandard Device 1 1
Device Emits Odor 1 1
Failure To Service 1 1
Inadequate Service 1 1
Device Operates Differently Than Expected 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Material Integrity Problem 1 1
Optical Problem 1 1
Protective Measures Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 3 3
No Information 1 1
No Code Available 1 1
Corneal Abrasion 1 1
Erythema 1 1
Eye Injury 1 1
Headache 1 1
Unspecified Infection 1 1
Irritation 1 1
Pain 1 1
Rash 1 1
Scarring 1 1
Blurred Vision 1 1
Visual Impairment 1 1
No Consequences Or Impact To Patient 1 1
Deformity/ Disfigurement 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Luxottica II Dec-22-2009
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