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U.S. Department of Health and Human Services

Product Classification

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Device extended depth of focus intraocular lens
Regulation Description Intraocular lens.
Definition Intended to be implanted to replace the natural lens of an eye.
Physical State An EDF IOL has a similar appearance and construction to any intraocular lens. An intraocular lens is a device made of materials such as glass or plastic.
Technical Method An Extended Depth of Focus Intraocular lens is one that uses an optical design (e.g., through aspheric shape, use of more than one refractive zone, or diffractive technology) that provides a continuous range of relatively clear vision, beyond that achievable with the optics of a monofocal lens. Extended Depth of Focus Intraocular lenses may have one or more focal points with any additional focal points or any significant light energy (on the optical axis) restricted to within 1.5 diopters (at the corneal plane) of the focal point associated with the labeled power when tested with a 3mm aperture.
Target Area Like all IOLs, an EDF IOL is implanted within the eye, either within or outside of the capsular bag, in the posterior or anterior chamber.
Regulation Medical Specialty Ophthalmic
Review Panel Ophthalmic
Product CodePOE
Premarket Review Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices (OHT1)
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
Implanted Device? Yes
Life-Sustain/Support Device? No
Recognized Consensus Standards
Third Party Review Not Third Party Eligible