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Product Classification

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Device

intraocular lens

Regulation Description

Intraocular lens.

Regulation Medical Specialty

Ophthalmic

Review Panel

Ophthalmic

Product Code

HQL

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

10-66 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
10-89 ANSI Z80.7-2013 (R2023)
American National Standard for Ophthalmic Optics - Intraocular Lenses
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
10-135 ISO 11979-7 Fifth edition 2024-01
Ophthalmic implants - Intraocular lenses - Part 7: Clinical investigations of intraocular lenses for the correction of aphakia
10-137 ISO 11979-2 Third edition 2024-10
Ophthalmic implants - Intraocular lenses - Part 2: Optical properties and test methods

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

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