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U.S. Department of Health and Human Services

Product Classification

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Device lens, iris reconstruction
Regulation Description Intraocular lens.
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.
Regulation Medical Specialty Ophthalmic
Review Panel Ophthalmic
Product CodeNIZ
Premarket Review Office of Device Evaluation (ODE)
Division of Ophthalmic and Ear, Nose and Throat Devices (DOED)
Intraocular and Corneal Implants Devices Branch (ICIB)
Submission Type PMA
Regulation Number 886.3600
Device Class 3
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Recognized Consensus Standards
Third Party Review Not Third Party Eligible
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