Product Classification

• Device: lens, multifocal intraocular
• Regulation Description: Intraocular lens.
• Regulation Medical Specialty: Ophthalmic
• Review Panel: Ophthalmic
• Product Code: MFK
• 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: Eligible
• Implanted Device?: Yes
• Life-Sustain/Support Device?: No

Recognized Consensus Standards

• 10-56 ANSI Z80.12-2007 (R2022)
  American National Standard for Ophthalmics - Multifocal Intraocular Lenses
• 10-66 ISO 10936-2 Second edition 2010-01-15
  Optics and photonics - Operation microscopes - Part 2: Light hazard from operation microscopes used in ocular surgery
• 10-78 ISO 11979-3 Third edition 2012-12-01
  Ophthalmic implants - Intraocular lenses - Part 3: Mechanical properties and test methods
• 10-95 ISO 11979-6 Third edition 2014-10-01
  Ophthalmic implants - Intraocular lenses - Part 6: Shelf-life and transport stability testing
• 10-98 ISO 11979-2 Second edition 2014-08-15
  Ophthalmic implants - Intraocular lenses - Part 2: Optical properties and test methods
• 10-105 ISO 11979-8 Third edition 2017-04
  Ophthalmic implants - Intraocular lenses - Part 8: Fundamental requirements
• 10-119 ISO 11979-5 Third edition 2020-09
  Ophthalmic implants - Intraocular Lenses - Part 5: Biocompatibility
• 10-120 ISO TR 22979 Second Edition 2017-05
  Ophthalmic implants - Intraocular Lenses - Guidance on assessment of the need for clinical investigation of intraocular lens design modifications
• 10-124 ISO 11979-1 Fourth edition 2018-11
  Ophthalmic implants - Intraocular lenses - Part 1: Vocabulary
• 10-125 ISO 11979-7 Fourth edition 2018-03
  Ophthalmic implants - Intraocular lenses - Part 7: Clinical investigations of intraocular lenses for the correction of aphakia
• 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.
• 10-135 ISO 11979-7 Fifth edition 2024-01
  Ophthalmic implants - Intraocular lenses - Part 7: Clinical investigations of intraocular lenses for the correction of aphakia

Guidance Document

• Endotoxin Testing Recommendations for Single-Use Intraocular Ophthalmic Devices - Guidance for Industry and Food and Drug Administration Staff

Third Party Review

Not Third Party Eligible