Product Classification

• 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 Code: QCB
• 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 Reporting: Ineligible
• Implanted Device?: Yes
• Life-Sustain/Support Device?: No

Recognized Consensus Standards

• 10-113 ANSI Z80.30-2018 (R2023)
  American National Standard for Ophthalmics - Toric Intraocular Lenses
• 10-124 ISO 11979-1 Fourth edition 2018-11
  Ophthalmic implants - Intraocular lenses - Part 1: Vocabulary
• 10-133 ISO 11979-10 Second edition 2018-03
  Ophthalmic implants - Intraocular lenses - Part 10: Clinical investigations of intraocular lenses for correction of ametropia in phakic eyes.

Third Party Review

Not Third Party Eligible