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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device prosthesis, eyelid spacer/graft, polymer
Regulation Description Ophthalmic conformer.
Definition For implantation to reinforce and aid in reconstruction of the soft tissues of the eyelid and eyelid area.
Product CodeQWU
Regulation Number 886.3130
Device Class 2


Premarket Reviews
ManufacturerDecision
CORNEAT VISION LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2024 27 27
2025 6 6

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 10 10
Adverse Event Without Identified Device or Use Problem 6 6
Migration 3 3
Expulsion 1 1
Use of Device Problem 1 1
Improper or Incorrect Procedure or Method 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Wound Dehiscence 19 19
Failure of Implant 6 6
Unspecified Eye / Vision Problem 6 6
Glaucoma 4 4
Discomfort 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Intraocular Pressure Increased 1 1
Vitreous Hemorrhage 1 1
Erosion 1 1

Recalls
Manufacturer Recall Class Date Posted
1 CORNEAT VISION, LTD. II Oct-03-2025
2 CORNEAT VISION, LTD. II Sep-05-2025
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