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TPLC - Total Product Life Cycle
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TPLC
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show TPLC since
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Device
sunglasses (non-prescription including photosensitive)
Product Code
HQY
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
2024
2
2
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
2
2
Material Fragmentation
2
2
Material Integrity Problem
1
1
Manufacturing, Packaging or Shipping Problem
1
1
Inadequate Service
1
1
Device Emits Odor
1
1
Device Operates Differently Than Expected
1
1
Protective Measures Problem
1
1
Failure To Service
1
1
Detachment Of Device Component
1
1
Optical Problem
1
1
Flaked
1
1
Loose or Intermittent Connection
1
1
Material Disintegration
1
1
Fogging
1
1
Nonstandard Device
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Known Impact Or Consequence To Patient
3
3
Eye Injury
2
2
Corneal Clouding/Hazing
1
1
Unspecified Infection
1
1
No Code Available
1
1
No Clinical Signs, Symptoms or Conditions
1
1
Corneal Abrasion
1
1
No Information
1
1
Scarring
1
1
Irritation
1
1
Rash
1
1
Erythema
1
1
Pain
1
1
Visual Impairment
1
1
Blurred Vision
1
1
Headache
1
1
No Consequences Or Impact To Patient
1
1
Deformity/ Disfigurement
1
1
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