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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device lens, iris reconstruction
Definition An iris reconstruction lens is an intraocular lens (IOL) which is used in patients with partial or complete loss of the iris induced by trauma or congenital defect. The IOL serves as an artificial iris and lens, reducing light sensitivity and/or glare disability. The device is implanted in the capsular bag or sulcus for the correction of aphakia and aniridia.
Product CodeNIZ
Regulation Number 886.3600
Device Class 3

MDR Year MDR Reports MDR Events
2016 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
Corneal Edema 2 2
Glaucoma 2 2
Iritis 1 1
Cataract, Induced 1 1

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