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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
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
2019 2 2
2020 3 3
2021 10 10
2023 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Patient-Device Incompatibility 4 4
Adverse Event Without Identified Device or Use Problem 4 4
Therapeutic or Diagnostic Output Failure 3 3
Insufficient Information 3 3
Detachment of Device or Device Component 2 2
Patient Device Interaction Problem 1 1
No Apparent Adverse Event 1 1
Device Appears to Trigger Rejection 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 4 4
Burning Sensation 3 3
Discomfort 3 3
Foreign Body In Patient 2 2
Red Eye(s) 2 2
Unspecified Infection 2 2
Inflammation 2 2
Insufficient Information 2 2
Intraocular Infection 1 1
Keratitis 1 1
Nausea 1 1
Swelling 1 1
Therapeutic Effects, Unexpected 1 1
No Known Impact Or Consequence To Patient 1 1
Cyst(s) 1 1
Dry Eye(s) 1 1
Foreign Body Sensation in Eye 1 1
Corneal Infiltrates 1 1
Excessive Tear Production 1 1
Ulcer 1 1

Recalls
Manufacturer Recall Class Date Posted
1 TissueTech, Inc. II Dec-09-2020
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