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U.S. Department of Health and Human Services

Product Classification

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Device phakic toric intraocular lens
Regulation Description Intraocular lens.
Definition Intended to be implanted within the eye to optically correct astigmatism (with or without other refractive errors), without removing the natural crystalline lens.
Physical State The device has a similar appearance and construction to any other intraocular lens. An intraocular lens is a device made of materials such as glass or plastic.
Technical Method The device is implanted into the eye without removing the natural crystalline lens. It is used to correct refractive errors, specifically astigmatism (with or without myopia or hyperopia).
Target Area The device is implanted within the eye without removing the eye's natural crystalline lens. It can be placed just in front of or just behind the iris.
Regulation Medical Specialty Ophthalmic
Review Panel Ophthalmic
Product CodeQCB
Premarket Review Ophthalmic Devices (DHT1A)
Ophthalmic Devices (DHT1A)
Submission Type PMA
Regulation Number 886.3600
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
Recognized Consensus Standards
Third Party Review Not Third Party Eligible
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