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U.S. Department of Health and Human Services

Product Classification

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Device artificial iris
Definition Artificial iris is intended to be implanted to replace the natural iris of the eye.
Physical State An artificial iris is manufactured from a polymeric material and may contain color additives to mimic the appearance of the natural iris.
Technical Method The artificial iris reduces the light sensitivity and/or glare associated with aniridia through the artificial pupil at the center of the prosthesis. The Artificial iris does not include optical power for the correction of refractive errors.
Target Area Eye
Review Panel Ophthalmic
Product CodeQBT
Premarket Review Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices (OHT1)
Ophthalmic Devices (DHT1A)
Submission Type PMA
Device Class 3
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Ineligible
Implanted Device? Yes
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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