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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device conformer, ophthalmic, biological tissue
Regulation Description Ophthalmic conformer.
Definition The ophthalmic conformer with molded plastic and biological tissue insert is introduced temporarily between the eyeball and eyelid to maintain space in the orbital cavity, prevent closure or adhesions during the healing process following surgery, and enables positioning of biological tissue to the ocular surface without the need for sutures.
Product CodeNQB
Regulation Number 886.3130
Device Class 2

MDR Year MDR Reports MDR Events
2021 10 10
2023 1 1
2025 6 6

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 5 5
Patient-Device Incompatibility 3 3
Insufficient Information 3 3
Therapeutic or Diagnostic Output Failure 3 3
Unsealed Device Packaging 1 1
Patient Device Interaction Problem 1 1
Unexpected Therapeutic Results 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Red Eye(s) 4 4
Eye Pain 4 4
Discomfort 3 3
Unspecified Infection 2 2
Burning Sensation 2 2
Insufficient Information 2 2
Pain 2 2
Chemosis 2 2
Swelling/ Edema 2 2
Foreign Body Sensation in Eye 1 1
No Clinical Signs, Symptoms or Conditions 1 1
Corneal Abrasion 1 1
Cyst(s) 1 1
Dry Eye(s) 1 1
Inflammation 1 1
Corneal Ulcer 1 1
Keratitis 1 1
Erythema 1 1
Fluid Discharge 1 1
Blurred Vision 1 1
Therapeutic Effects, Unexpected 1 1
Loss of Vision 1 1
Corneal Scar 1 1
Corneal Infiltrates 1 1
Excessive Tear Production 1 1
Increased Sensitivity 1 1

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