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Phakic Toric Intraocular Lens

Page Type
Product Code
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
Submission Type
PMA
Device Classification
Class 3
Regulation Number
886.3600
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
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.

Phakic Toric Intraocular Lens

Page Type
Product Code
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
Submission Type
PMA
Device Classification
Class 3
Regulation Number
886.3600
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
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.