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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device graft insertion instrument for endothelial keratoplasty
Regulation Description Intraocular lens guide.
Definition A graft insertion device for endothelial keratoplasty is a device intended to be inserted into the eye during surgery to direct the insertion of a corneal graft and be removed after insertion is completed.
Product CodeOTZ
Regulation Number 886.4300
Device Class 1


Premarket Reviews
ManufacturerDecision
CORNEAGEN, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2024 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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