Recognition List Number: 020 Publication Date: 09/09/2008
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 10-42: ISO 11979-2 First edition 1999-12-15/ ISO 11979-2:1999, TECHNICAL CORRIGENDUM 1 Ophthalmic implants - Intraocular lenses -- Part 2: Optical properties and test methods. (Ophthalmic)
Date of Standard: 1999. |
| Address of Standards Organization: |
| International Organization for Standardization (ISO)* |
| 1, Rue de Varembe |
| Case Postale 56 |
| CH 1211 Geneva 20, 0 |
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SWITZERLAND
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| CDRH Office and Division Associated with Recognized Standards: |
| OFFICE OF DEVICE EVALUATION (ODE) | | DIVISION OF OPHTHALMIC AND EAR, NOSE AND THROAT DEVICES (DOED) |
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| Devices Affected: |
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| Processes Affected: |
| 510(k), PMA, IDE, PDP, HDE, Design Control Input |
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| Type of Standard: |
| Vertical, International |
| Extent of Recognition: |
Complete standard and any annexes, and corrigendum with the following addition.
Clause 4.1 describes the general optical requirements for IOLs. Additionally, it is required that the diameter of the clear lens optic with refractive power should be greater than or equal to 4.25 mm. Components such as positioning holes and haptics should not infringe on this minimum diameter. |
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| Related CFR Citations and Product Codes: |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §886.3600 |
Intraocular Lens |
Class 3 |
HQL |
| §886.3600 |
Lens, Iris Reconstruction |
Class 3 |
NIZ |
| §886.3600 |
Lens,Intraocular,Accommodative |
Class 3 |
NAA |
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| Relevant Guidance: |
| There is no relevant guidance developed at this time. |
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| FDA Technical Contact: |
| Don Calogero |
| FDA/CDRH/ODE |
| 10903 New Hampshire Avenue Building 66, Room 2500 |
| Silver Spring MD 20993 |
| 301/796-6483 |
| Email: don.calogero@fda.hhs.gov |
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