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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device hydrophilic re-coating solution
Regulation Description Hydrophilic re-coating solution.
Definition A hydrophilic re-coating solution is a home use device intended to restore the hydrophilic coating of rigid gas permeable (RGP) contact lenses using reactive coating components. For prescription use only.
Product CodeQMM
Regulation Number 886.5919
Device Class 2

MDR Year MDR Reports MDR Events
2025 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1 1

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