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Extended Depth Of Focus Intraocular Lens

Page Type
Product Code
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
Submission Type
PMA
Device Classification
Class 3
Regulation Number
886.3600
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
Yes
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 886.3600 Intraocular lens

§ 886.3600 Intraocular lens.

(a) Identification. An intraocular lens is a device made of materials such as glass or plastic intended to be implanted to replace the natural lens of an eye.

(b) Classification. Class III.

(c) Date PMA or notice of completion of a PDP is required. As of May 28, 1976, an approval under section 515 of the act is required before this device may be commercially distributed. See § 886.3.

Extended Depth Of Focus Intraocular Lens

Page Type
Product Code
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
Submission Type
PMA
Device Classification
Class 3
Regulation Number
886.3600
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
Yes
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 886.3600 Intraocular lens

§ 886.3600 Intraocular lens.

(a) Identification. An intraocular lens is a device made of materials such as glass or plastic intended to be implanted to replace the natural lens of an eye.

(b) Classification. Class III.

(c) Date PMA or notice of completion of a PDP is required. As of May 28, 1976, an approval under section 515 of the act is required before this device may be commercially distributed. See § 886.3.