Product Classification

• Device: lens, iris reconstruction
• Regulation Description: Intraocular lens.
• Definition: An iris reconstruction lens is an intraocular lens (IOL) which is used in patients with partial or complete loss of the iris induced by trauma or congenital defect. The IOL serves as an artificial iris and lens, reducing light sensitivity and/or glare disability. The device is implanted in the capsular bag or sulcus for the correction of aphakia and aniridia.
• Regulation Medical Specialty: Ophthalmic
• Review Panel: Ophthalmic
• Product Code: NIZ
• Premarket Review: Ophthalmic Devices (DHT1A); 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

• 10-78 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
• 10-124 ISO 11979-1 Fourth edition 2018-11
  Ophthalmic implants - Intraocular lenses - Part 1: Vocabulary

Third Party Review

Not Third Party Eligible