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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 shield, eye, ophthalmic (including sunlamp protective eyewear and post-mydriatic eyewear)
Product CodeHOY
Regulation Number 886.4750
Device Class 1

MDR Year MDR Reports MDR Events
2020 1 1
2021 2 2
2023 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Break 1 1
Component or Accessory Incompatibility 1 1
Detachment of Device or Device Component 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Injury 1 1
Unspecified Tissue Injury 1 1
Insufficient Information 1 1
No Clinical Signs, Symptoms or Conditions 1 1

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