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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device lens, fundus, hruby, diagnostic
Product CodeHJI
Regulation Number 886.1395
Device Class 1

MDR Year MDR Reports MDR Events
2021 1 1
2023 11 11

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 11 11
Appropriate Term/Code Not Available 1 1
Detachment of Device or Device Component 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Inflammation 2 2
Retinal Detachment 2 2
Corneal Abrasion 2 2
Hemorrhage/Bleeding 2 2
Irritability 2 2
Foreign Body In Patient 1 1
Eye Pain 1 1
Swelling/ Edema 1 1
Hyperemia 1 1
Hypersensitivity/Allergic reaction 1 1
Corneal Edema 1 1
Macular Edema 1 1
Blurred Vision 1 1
No Clinical Signs, Symptoms or Conditions 1 1

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